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Objective To explore the construction of a real-world data annotation platform, and compare the real-world data extraction performance of retrieval augmented generation (RAG) combined with large language models and pre-training fine-tuning methods for pre-trained language models.Methods Taking the pathological records of bladder cancer in the real world electronic medical record data as an example, a real-world data annotation platform was built. Based on the platform annotation data, the effects of automatic extraction of cancer typing and staging of bladder cancer using RAG combined with GPT-3.5, and the pre- training fine tuning method based on BERT and RoBERTa models were compared. Results The extraction effects of the pre-training and fine-tuning model based on the fine-tuning of the full-training set were better than that of RAG combined with large model method and pre-training and fine-tuning model with the few-shot fine-tuning, and the effects of RoBERTa model were generally better than that of BERT model, but the extraction effects of these methods needs to be improved totally. The F1 scores for extracting bladder cancer typing, T staging, and N staging in the test set, using the RoBERTa model fine-tuned with the entire training set, were 71.06%, 50.18%, and 73.65% respectively. Conclusion Pre-trained language models have the application potential in processing clinical unstructured data, but there is still room for improvement in the information extraction effect of existing methods. Future work requires further optimization of models or training strategies to accelerate data empowerment.

Background and objective Pembrolizumab (PEM) has been shown to be effective in clinical trials for the treatment of advanced non-small cell lung cancer (NSCLC), but clinical trials were based on cohorts of patients selected on specific criteria, and whether the findings are consistent with real-world patients is debatable. The aim of this study is to evaluate the efficacy and safety of PEM in the treatment of advanced NSCLC based on real-world data. Methods A retrospective collection of real-world data from patients with advanced NSCLC receiving PEM was conducted. Propensity score matching was used to eliminate inter-group differences and assess the efficacy and safety of PEM compared to chemotherapy. Results Among 450 matched patients, the incidence rates of any-grade adverse events were 79.87% in the PEM group and 86.71% in the chemotherapy group, while the incidence rates of grade ≥3 adverse events were 4.03% and 7.31%, respectively. The objective response rates were 48.63% for PEM and 36.00% for chemotherapy (P=0.011). The median progression-free survival was 15.5 months for PEM and 8.8 months for chemotherapy (P

Objective To explore the effectiveness and safety of belimumab in Chinese adult lupus nephritis (LN) patients under a real-world setting. Methods For this retrospective cohort study, 30 LN patients received belimumab plus standard of care (SoC) due to a new onset or a relapse of LN from June 2021 to December 2022. And 30 matched patients only treated with SoC after propensity score matching (PSM) at the same period were also enrolled. After 24-week follow-ups, renal complete remission (CR), disease activity index, 24 h urine protein level, dose of prednisone and incidence of adverse events were compared. Results No statistically significant differences existed in baseline demographics, complement C3/C4, anti-dsDNA autoantibody titer, 24 h urine protein level or disease activity index. At Week 24, 21/30 patients achieved renal CR and it was higher than that of SoC group (21 vs 12, P=0.037). As compared with SoC group, belimumab group had lower levels of 24 h urine protein[346.50(183.75，571.00) mg vs 611.50(360.00，1450.00) mg], SLEDAI-2K (SLE disease activity index, SLEDAI-2K) score[(3.93±2.79) vs (5.70±3.14)] and daily prednisone dose [(11.67±4.34) mg/d vs (22.42±9.23) mg/d](P＜0.05). Furthermore, the incidence of adverse events between two group was comparable (P>0.05). Conclusions Belimumab plus SoC may alleviate LN, boost the rate of renal CR, lower 24 h urine protein levels, improve disease activity and reduce the intake of prednisone.

With the development of medical big data, the real-world study (RWS) has received increasing attention in recent years, and has a good promising prospect. However, there are still some challenges in the implementation of RWS that has led to extensive discussion among scholars. The most urgent issue currently to be addressed is the unstructured nature of real-world data (RWD). Based on regular expressions, this study used rule-based information extraction method to extract structured information from admission records, pathological reports, surgical records, and image records of bladder cancer patients in Zhongnan Hospital of Wuhan University in recent years, and evaluated the extraction effects with accuracy and recall as indicators, aiming to provide reference for subsequent research.

'Target trial emulation' (TTE), as a new framework in real-world research, has been formally established in recent years. It can be used to guide the evaluation of the effectiveness and safety of medical interventions based on real-world data for observational causal inference. The core idea of this framework is to follow the principles of randomized controlled trial (RCT), emulate a corresponding RCT using real-world data, and then draw conclusions about the causal relationship between interventions and outcomes. The main implementation tips of TTE can be summarized as '3-7-2': 3 implementation steps including formulating the causal question, designing the emulation plan, and emulating the target study; 7 design elements including eligibility criteria, treatment strategies, intervention allocation, follow-up period, outcome, causal contrast of interest, and analysis plan; and control of 2 critical biases including immortal time bias and prevalent user bias. In this article, we present an overview of the development, current status, implementation steps, classic examples, advantages and limitations of TTE, and its application prospects in traditional Chinese medicine (TCM). It is hoped that this article can assist researchers in TCM to utilize this method for real-world research and contribute to the construction of a clinical evaluation system with distinctive features of TCM.

Background Breast cancer is the most prevalent malignancy in the world. Endocrine therapy reduces the level of estrogen in vivo, thus affecting the blood lipid level, which reduces the quality of life and the treatment compliance of patients. Objective To analyze the clinical characteristics and traditional Chinese medicine (TCM) prescription of hyperlipidemia in estrogen receptor (ER) positive breast cancer patients during endocrine therapy in real world. Methods Based on method of retrospective study, a total of 238 patients with ER positive breast cancer who received endocrine therapy in Affiliated Hospital of Shandong University of Traditional Chinese Medicine from January 2012 to March 2022 were selected as the study subjects. The data including age, triglyceride, total cholesterol, low density lipoprotein, endocrine therapy drugs, TCM prescriptions of the patients were exported through the search platform of scientific research big data to establish a clinical data table of the patients. ER positive breast cancer patients with normal baseline blood lipid levels were divided into the normal group and dyslipidemia group according to the blood lipid levels during endocrine therapy, and hyperlipidemia was classified into hypercholesterolemia, hypertriglyceridemia and mixed hyperlipidemia. The exported prescriptions were analyzed for frequency, four properties, five flavors, channel tropism and medication regularity by using the "prescription analysis", an auxiliary platform for TCM inheritance, to obtain new prescriptions. Results Among 238 ER positive breast cancer patients, 97 patients (40.8%) had normal baseline blood lipid levels, of whom 42 patients (205 person-time return visit) developed dyslipidemia during standardized endocrine therapy. Among the patients with dyslipidemia, 37.6% (77/205) occurred in the age group of 51 to 60 years as the highest number; 86 person-time with dyslipidemia received exemestane treatment, accounting for the highest proportion of 42.0%. Among the 42 patients with dyslipidemia (205 person-time return visit) , hyperlipidemia occurred in 99 person-time, and hypercholesterolemia occurred in 49.5% (49/99) . There was no statistically significance difference in the age of patients with three types of hyperlipidemia (P>0.05) . There were statistically significance differences in the proportion of endocrine therapy types among patients with three types of hyperlipidemia (P

As optimization problems grow increasingly complex, characterized by their intricate difficulty, larger-scale, and diverse constraints, swarm intelligence optimization algorithms have emerged as an effective solution for addressing these multifaceted challenges. Among these, the marine predators algorithm, a recent innovation in intelligent optimization algorithms, has demonstrated remarkable efficacy in solving optimization issues. However, its application to complex CEC test function sets and engineering constraint problems reveals several limitations, including limited adaptive ability, low optimization accuracy, and high local shackle probability. This paper proposes an enhanced version of the marine predators algorithm designed to overcome its inherent shortcomings. The enhancement begins with the integration of a learning automata guided teaching–learning search mechanism during the marine memory stage. This adjustment aims to strike a better balance between exploration and exploitation across different iteration periods. Subsequently, the introduction of a logarithmic spiral exploration mechanism phase strengthens the algorithm’s ability to conduct nuanced searchers around the optimal solution, thereby improving convergence accuracy. Finally, an improved adaptive relative reflection strategy is added at the end of each iteration to enhance the algorithm’s capability to escape local optima and reduce the risk of local shackling. The optimization performance of this refined algorithm is evaluated through parameter sensitivity analysis, determining the optimal parameter values. To validate its effectiveness, the improved algorithm undergoes testing against six benchmark algorithms, including the basic marine predators algorithm and its variants, as well as other improved algorithms and those recognized with awards in the CEC2017 test suite across 100 dimensions. The evaluation focuses on optimization accuracy, the Wilcoxon rank sum test, and boxplot analysis. The test results indicate that the improved algorithm proposed in this paper outperforms the other six benchmark algorithms in optimization precision, convergence rate, and solution stability, particularly when solving complex functions in high-dimensional (100 dimensions) spaces. Furthermore, the applicability and superior performance of the improved algorithm are demonstrated through comparative analysis with four established algorithms on challenging engineering design optimization problems. These include welded beam design, process synthesis, heat exchanger network design, and design optimization of industrial refrigeration systems. The findings unequivocally showcase the enhanced algorithm’s exceptional ability to solve various engineering constraint problems effectively.

With the popularization and promotion of information technology, healthcare big data is growing exponentially, and clinical real-world research based on healthcare big data is receiving increasing attention. The hospital electronic medical record (EMR) records the whole process of diagnosis and treatment of patients in the "real-world", and is one of the most supportive data sources for clinical decision-making. However, the existence of a large number of unstructured text data in EMR data increases the difficulty of data processing and restricts the development of research based on EMR data. Advanced methods such as information technology and artificial intelligence need to be applied to the processing of unstructured EMR data to accelerate the transformation of data value. This paper summarizes the current common methods of unstructured medical data processing, including methods based on dictionaries and rules, methods based on traditional machine learning and deep learning, and methods based on cognitive models represented by ontology, and also discusses the problems of standardization and transparent reporting when processing unstructured EMR data and looks forward to the relevant development.

Objective·To construct a clinical database of diabetes in Shanghai, mine the value of clinical data, and carry out real-world study.Methods·The data were extracted from Shanghai Link Healthcare Database. All original clinical data have undergone standard processes such as desensitization, encryption, cleaning, standardization, information extraction and structuring, and clinical data were analyzed by the method of medical statistics or machine learning according to different research contents.Results·The database has imported the clinical data of 150 million visits and treatment records of 2.12 million diabetic patients in 37 municipal hospitals over a ten-year period from 2013 to 2022. The overall analysis showed the basic characteristics and development trends of all aspects of diabetes disease in real-world settings, the potential risks of diabetes are discovered by constructing retrospective cohort, and the inherent patterns of the disease are revealed by using machine learning methods such as cluster analysis and network analysis.Conclusion·The establishment of Shanghai Diabetes Clinical Database can not only summarize and show the clinical status of diabetes, but also obtain more scientific achievements with realistic clinical value by real-world clinical data study.

Background and purpose: The development and approval of inhibitors of cyclin-dependent kinase 4/6 (CDK4/6) is an essential milestone in treating hormone receptor-positive metastatic breast cancer. The efficacy of these drugs is similar, but the adverse events (AE) are different, directly affecting the physician's choice of drug. There is no systematic study on the safety of CDK4/6 inhibitors in the real world. In this study, we compared the differences in AE of CDK4/6 inhibitors through signal mining in the FDA Adverse Event Reporting System (FAERS) and identified unknown AE signals to provide a reference for the clinical choice of treatment and monitoring AE. Methods: All data in the FAERS database were extracted from the first quarter of 2004 to the first quarter of 2023. After removing duplicates, data were analyzed by the disproportionality method for reports ranking palbociclib, abemaciclib, or ribociclib as the primary suspect. Signals were identified using the reporting odds ratio (ROR) and MHRA methods. Positive signals were required to meet the following criteria: the number of reports ≥3, the lower limit of the 95% confidence interval of the ROR >1, proportional reporting ratios (PRR) >2, and the χ2 >4. Results: A total of 85 562 reports of AE associated with CDK4/6 inhibitors were identified. The highest signal intensity of palbociclib was observed in hematologic and lymphatic AE (leukopenia ROR = 20.01). Palbociclib had lower AE signals in the gastrointestinal, hepatic, and renal systems than the other drugs (diarrhea ROR = 1.95, gamma-glutamyltransferase increased ROR = 0.36, blood creatinine increased ROR = 1.01). Abemaciclib had the strongest signal in the gastrointestinal system (diarrhea ROR = 13.54); it also showed a strong AE signal in the hepatic and renal systems (gamma-glutamyltransferase increased ROR = 2.58, blood creatinine increased ROR = 7.74) and a lower AE signal than the other drugs in the blood and lymphatic systems (leukopenia ROR = 5.34). Ribociclib had a lower AE signal intensity in the blood and lymphatic system than palbociclib (leukopenia ROR = 7.55); however, among hepatic AE, ribociclib had the highest signal intensity of increased gamma-glutamyltransferase (ROR = 4.05). In rare severe hepatic systemic AE, abemaciclib had the strongest signal in hepatic failure (ROR = 3.50) and drug-induced liver injury (ROR = 4.68). Erythema multiforme was a newly identified signal in the abemaciclib reports (ROR = 3.06). Conclusion: The safety profile of CDK4/6 inhibitors varies. Analysis of the FAERS database revealed hematologic and lymphatic system toxicities for palbociclib and ribociclib and gastrointestinal and hepatorenal toxicities for abemaciclib. Erythema multiforme was found as a novel severe AE for abemaciclib. Individualized drug selection and monitoring of AE based on the patient’s physiological status and AE are needed during treatment.

Clinical practice guidelines are an important basis for clinical decision-making, but there are still many factors that prevent physicians from following the guidelines. One of the problems, the limited external validity of the guidelines, ultimately prevents the guidelines from providing an adequate basis for clinical decision-making, thus forming the gap between the guidelines and clinical decisions. Real-world research can enhance the external validity of the guidelines, provide a basis for clinical decision-making, and offer localized evidence for the guidelines, evidence of cost-effectiveness and other evidence for the guidelines. It can also monitor the implementation of the guidelines and help to make up for the lack of evidence in the formulation of traditional guidelines. Therefore, high-quality real-world studies and real-world evidence may be considered in the guideline development process to facilitate guideline optimization and serve as an aid to guideline quality improvement.

Objective To compare the efficacy and safety of vedolizumab (VDZ) and infliximab (IFX) for moderate to severe ulcerative colitis (UC) patients through a multicenter retrospective cohort study. Methods All patients with moderate to severe UC who were naive to biologic agents and treated with IFX or VDZ for at least 14 weeks at 3 hospitals in Southwest China between January 2021 and January 2023 were retrospectively enrolled. The efficacy evaluation indicators, including steroid-free clinical remission rates, clinical remission rates and endoscopic remission rates at weeks 14 and 52 were compared between the 2 groups. The occurrence of adverse events during treatment were recorded. Taking whether mucosal healing could be achieved after 14 and 52 weeks of treatment as the dependent variable, firstly, univariate analysis was performed to analyze the risk factors affecting mucosal healing at weeks 14 and 52, and then multivariate logistic regression analysis was applied to identify the independent risk factors of mucosal healing at the 2 time points. Results A total of 151 patients with moderate to severe UC were included, after propensity score matching (PSM), each group included 57 patients. There were no significant differences in the steroid-free clinical remission rate and clinical remission rate between the 2 groups at weeks 14 and 52 (P>0.05). The endoscopic remission rate at week 14 was significantly higher in the VDZ group than the IFX group [40.4% (23/57) vs 22.8% (13/57), P=0.044], but no such difference was observed at week 52 [64.5% (20/31) vs 59.5% (22/37), P=0.669]. Multivariate logistic regression analysis showed that left-sided disease (E2) [vs pancolitis (E3)](OR=0.46, 95%CI: 0.21~0.98, P=0.045) was independent risk factor for mucosal healing at week 14 and a disease duration ≥36 months (OR=0.25, 95%CI: 0.09~0.66, P=0.005) was independent risk factor for mucosal healing at week 52. No statistical difference was observed in the incidence of adverse events between the 2 groups (1.8% vs 7.0%, P=0.360). Conclusion VDZ and IFX have similar efficacy and safety, and both can be used as first-line options for patients with moderate to severe UC.

Background Multiple myeloma (MM) is a common hematologic malignancy. With the emergence of a variety of new drugs, the survival rates of patients have increased, however, further discussion on how to achieve deeper and faster remission and reduce recurrence of patients is still needed. Objective To investigate the efficacy and safety of daratumumab in the chemotherapy of MM. Methods 73 MM patients treated with daletumab in Sichuan Provincial People's Hospital from January 2020 to July 2022 were included as study subjects. Baseline information of the included patients were collected through the electronic medical record system. All patients were treated with daletumab based regimen and followed up through outpatient and inpatient review and telephone once a month when it is not time for review, with the time of first use of darettuzumab since 2020-01-01 as the starting point, death, disease recurrence or end of follow-up as the ending point. Follow-up was up to 2022-07-31 with a median follow-up time of 6.5 (0.5, 26.5) months. Overall response rate (ORR) and complete response rate were used to evaluate the efficacy of the patients. Kaplan-Meier curves were plotted for different drug use, initial renal function, drug administration, cytogenetic risk stratification and M protein types, and compared by Log-rank test. Results The median age of the patients was 64 (30, 86) years, including 38 males and 35 females. 28 MM patients were treated with first-line darettuzumab, 13 were switched from other regiments to darettuzumab due to adverse reactions, and 32 patients had relapsed and refractory multiple myeloma (RRMM). 18 patients were lost during follow-up, and a total of 55 patients were available for efficacy assessment. After one course of treatment with the darettuzumab-based chemotherapy regimen, ORR was 72.7% with the complete response rate of 30.9%, including 3.6% (2/55) achieved strin-gent complete response (sCR) and 27.3% (15/55) achieved complete response (CR), 10.9% (6/55) achieved very good partial response (VGPR), 30.9% (17/55) achieved partial response (PR), 9.1% (5/55) achieved minimal response (MR), 12.7% (7/55) achieved stable disease (SD), and 5.5% (3/55) achieved disease progression (PD). The median progress free survival (PFS) of the patients was 6.0 (0.5, 26.5) months, and the median overall survival was 16 (3, 103) months. There was no statistically significant difference in the PFS survival curve between patients treated first-line with darettuzumab and RRMM patients (χ2=3.676, P=0.055). The difference of PFS survival curve between patients with normal and impaired renal function was statistically significant (χ2=12.51, P=0.004). There was a statistically significant difference in the survival curve of patients treated with daletumab + bortezomib + dexamethasone and those treated with daletumab + dexamethasone (χ2=6.691, P=0.009). There was no statistically significant difference in PFS survival curves between patients with non-high risk and high-risk cytogenetic classification (χ2=0.328, P=0.567). There was no statistically significant difference in PFS survival curves among patients with M protein types of IgA, IgG, IgD, light chain, double clone and non-secretory (P>0.05). The main adverse reactions of the patients were infusion reaction and myelosuppression, of which 21 patients had adverse infusion reactions at the first infusion, 21 patients had leukopenia, 40 patients had anemia and 16 patients had thrombocytopenia. Conclusion Darettuzumab has good curative effect in MM patients, which can be used as the first-line treatment for newly diagnosed patients, improve the clinical prognosis of RRMM patients, and prolong the survival time of patients.

The safety and survival benefits of abiraterone acetate and docetaxel in the treatment of patients with metastatic hormone-sensitive prostate cancer have been confirmed by randomized controlled trials and clinical studies abroad. However, real-world studies remain lacking. In this article, we review the progress of real-world studies of abiraterone acetate and docetaxel in the treatment of patients with metastatic hormone-sensitive prostate cancer and the problems faced in clinical practice against the background of differentiated real-world studies. Further research is needed to address clinically important issues, such as individualized dosing, combination dosing, and monitoring of adverse effects.

The real-world data comes from the real medical environment, which can reflect the med-ical process and the patient's health status under real clinical conditions, and can be used as an important source of evidence and knowledge. As a semantic network, knowledge map can be used to organize, pre-sent and reason medical knowledge. The combination of real-world data and knowledge map can better supplement, display and use medical knowledge. At present, using real-world data to build a medical knowledge map or using real-world data to complete the medical knowledge map are the main ways of combining the two applications. When carrying out the application research on the combination of re-al-world data and medical knowledge map, attention should be paid to the issues about the multidiscipli-nary team collaboration, patient privacy protection and data standardization.

Objective To explore the efficacy, safety, and factors that might influence the efficacy of antiPD-1 antibody-based therapy in advanced hepatocellular carcinoma in the real world. Methods The clinical features, efficacy, and safety in patients with advanced hepatocellular carcinoma who received anti-PD-1 antibody-based therapy were retrospectively analyzed. The survival status was followed-up. Results The objective response and the disease control rate were 21.8% and 76.4%, respectively. The overall incidence of adverse events during treatment was 81.8%, of which the incidence of grade 3/4 adverse events was 14.5%. The incidence of immune-related adverse events was 58.2% and the incidence of grade 3/4 immune-related adverse events was 3.6%, and no treatment-related death was observed. The median PFS of the 55 patients was 5.0 (95%CI: 3.9-6.1) months, and the median OS was 11.4 (95%CI: 6.5-16.3) months. Univariate and multivariate analyses showed that liver function Child-Pugh scores and performance status ECOG score were the influencing factors of the objective response rate and survival. Conclusion In the real world anti-PD-1 antibody-based therapy is safe and effective in patients with advanced hepatocellular carcinoma, in which the performance status ECOG score and liver function Child-Pugh score before treatment are independent prognostic factors influencing survival.

ObjectiveTo picture the trajectory of changes in glucose and lipid metabolism among schizophrenic patients in long-term hospitalization.MethodsA total of 109 inpatients of Shenzhen Kangning Hospital from 2014 to 2022， who were diagnosed with schizophrenia based on the International Classification of Diseases， tenth edition （ICD-10） criteria， were recruited as subjects. Real-world follow-up data on longitudinal glucose metabolism （fasting blood glucose， glycosylated hemoglobin， C-peptide） and lipid metabolism （triglycerides， low density lipoprotein， high density lipoprotein， total cholesterol） were observed. The frequency of visit was once a year， with a total of 9 visits over 8 years.ResultsIn terms of glucose metabolism parameters， fasting blood glucose level decreased to 4.87 mmol/L at the 7th visit， lower than the baseline level （P

Background Arrhythmia has a high incidence, and is a serious threat to human health. However, due to concealed symptoms and unpredictability of onset, it is difficult for traditional ECG equipment to capture the ECG data at the onset of the arrhythmic events, so it could be misdiagnosed and under-treated. Fortunately, the diagnosis rate of arrhythmia could be greatly enhanced by analyzing the uploaded real-time ECG data of individuals measured at home using the wearable single-lead ECG monitoring system under the guidance of community doctors, but there is a lack of relevant evidence from real-world studies. Objective To assess the diagnostic accuracies of three schemes for screening arrhythmia in the community using a wearable single-lead ECG monitoring system. Methods A real-world, community-based study design was used for comparing three schemes for screening arrhythmia using a wearable single-lead ECG monitoring system: scheme 1 was used for collecting 24-hour ECG data on any three nonconsecutive days in two weeks, scheme 2 was used for collecting 24-hour ECG data on any day and at least three 1-hour ECG data in two weeks, and scheme 3 was adopted for collecting 72-hour ECG data on any three consecutive days and at least one 1-hour ECG data on any one day in two weeks. Subjects were 435 community-living residents, who were recruited from Yinchuan from September 2020 to September 2021. They were divided into male group (177 cases) , female group (258 cases) ; young group (135 cases) , middle-aged group (200 cases) and elderly group (100 cases) by age; primary school group (77 cases) , middle school group (165 cases) and university group (193 cases) by educational level; arrhythmia group (233 cases) and non-arrhythmia group (202 cases) by the history of arrhythmia. Subjects measured the ECG either at the onset time of perceived arrhythmia or not using any one of the three screening schemes chosen voluntarily with the wearable single-lead ECG monitoring system, then uploaded the measurement results to the cloud platform. The number of participants using each of the three screening schemes was counted. The correlation of age, education level or history of arrhythmia with scheme selection was analyzed. And detection rates of the three screening schemes were compared. Results The number of subjects who selected the three screening schemes was 321, 40 and 74, respectively. The average age of the subjects was significantly different (P=0.047) . There was no correlation between gender, education level, medical history and protocol selection (χ2=0.670, P=0.715; χ2=2.994, P=0.559; χ2=2.225, P=0.893) . There was a significant correlation between different age groups and protocol selection (χ2=9.939, P=0.041) . The arrhythmia detection rates of the three screening protocols were 85.67%, 82.50% and 85.14%, respectively, and the difference was not statistically significant (χ2=0.286, P=0.867) . There was no significant difference in the arrhythmia detection rate between the male group and the female group (χ2=0.966, P=0.707; χ2=0.917, P=0.678) . There was no significant difference in the detection rate of arrhythmia among young group, middle-aged group and elderly group (χ2=2.102, P=0.350; χ2=0.871, P=0.706; χ2=1.063, P=0.622) . There was no significant difference in the detection rate of arrhythmia among the three screening schemes in primary school group, middle school group and university group (χ2=2.421, P=0.271; χ2=1.115, P=0.633; χ2=2.181, P=0.353) . There was no significant difference in the arrhythmia detection rate between the three screening protocols in the history group and the no history group (χ2=1.442, P=0.507; χ2=0.548, P=0.818) . The frequency of 1-hour ECG data collection in protocol 2 was positively correlated with arrhythmia detection rate (rs=0.912, P=0.011) . The frequency of 1-hour ECG data collection in protocol 3 was positively correlated with arrhythmia detection rate (rs=0.852, P=0.026) . In protocol 2, the detection rate of arrhythmia in 24-hour ECG data was 72.5%, and that in 1-hour ECG data was 77.5%. There was a strong consistency between the two kinds of long-term ECG data (Kappa=0.601, P=0.001) . In protocol 3, the arrhythmia detection rate of 72-hour ECG data was 82.4%, and the arrhythmia detection rate of 1-hour ECG data was 63.5%. There was a medium consistency between the two kinds of long-term ECG data (Kappa=0.410, P

Background and purpose: Effective treatment for cervical cancer patients is one of the global strategies to eliminate cervical cancer. By analyzing the metastasis characteristics and survival status of patients with distant metastasis of cervical cancer from a hospital-based cancer registry data, our study provided real-world evidence for better survival of cervical cancer and finally eliminating cervical cancer. Methods: A total of 572 cervical cancer patients who had metastasis cancer at the initial diagnosis or developed distant metastasis during follow-up in Fudan University Shanghai Cancer Center from 2008 to 2017 were included in this study. Medical records review, telephone visits and death registry data linkage were applied in collecting endpoint data. The first follow-up date was the diagnose date of metastasis, and the last follow-up date was November 1, 2020. Kaplan-Meier method was applied in evaluating the 1-, 3- and 5-year overall survival (OS) rates for overall and site-specific patients. Results: The median follow-up time was 38.93 months, and 348 cases died during the follow-up. 72.55% were single site metastasis, and 27.45% were multiple metastases. Among all metastatic sites, the proportion of lung metastasis was the highest, 41.26%, 15.21% to bone, and 11.54% to liver. After metastasis, the 1-year, 3-year and 5-year OS rates were 62.29% (95% CI: 62.25-62.33), 33.13% (95% CI: 33.08-33.18) and 23.42% (95% CI: 23.37-23.47), respectively. In single site metastasis, 1-year OS was the highest after metastasis to the lung (72.52%). Besides, there was no significant difference among different metastatic sites, both in 3-year and 5-year OS. Conclusion: The most frequent distant metastatic sites of cervical cancer are lung, bone and liver. The survival rate after metastasis is poor. Further research with systematic treatment strategy is required for better survival.

国家监管部门及研究领域专家发表了针对真实世界数据和真实世界证据的一系列指导原则和研究，但真实世界研究的详细撰写方法和设计分析要点都仍未有明确的文件指导。本文综合梳理真实世界数据相关的各项文件和研究，结合研究方案设计经验，形成基于真实世界数据研究的设计要点和统计分析解析。真实世界研究的研究方案中需要充分说明真实世界数据的适用性，从数据来源、数据相关性、数据完整性、数据准确性和数据提取方法等方面全面阐述数据治理方法，评估数据质量。利用统计学方法分析真实世界研究结论的可靠性和稳健性，得出高质量的真实世界证据。 Abstract: National regulatory authorities and experts have published a series of guidelines and studies on real-world data and real-world evidence, but there is still no clear document guidance on the detailed protocol and statistical analysis methodology of real-world research. We comprehensively reviewed various documents and studies related to real-world data, based on the experience of research protocol design, and developed the research design key points and statistical analysis based on real-world data. The protocol of real-world research needs to explain the applicability of real-world data, comprehensively explain data governance methods from the aspects of data source, data relevance, data integrity, data accuracy and data extraction methods, and evaluate data quality. Statistical analysis methods are used to analyze the reliability and robustness of real-world research conclusions, thus to produce high-quality real-world evidence.

真实世界研究由于其研究结果更贴近真实世界，在临床研究领域逐渐受到关注和重视。真实世界研究不是并列于观察性研究和试验性研究的某种特定的研究设计类型，在真实世界研究的数据分析中更需要关注混杂因素和协变量的控制。正确识别混杂因素和协变量以及合理应用统计方法对其进行控制，可有效提高研究结论的准确性和真实性。本文介绍了真实世界研究中混杂因素和协变量控制的常见方法，包括分层分析、协方差分析、多因素回归、倾向性评分、疾病风险评分和工具变量分析等，并结合脑血管病的临床研究应用实例展开分析，以期为研究者理解与应用相关方法提供参考。 Abstract: Real-world studies have increasely become the focus in the field of clinical research because their findings are closer to the real world. However, real-world study is not a specific type of research design parallel with observational studies and experimental studies, and the control of confounding factors and covariates in the data analysis of real-world studies should be paid more attention. Correct identification of confounding factors/covariates and reasonable application of statistical methods can effectively improve the accuracy and authenticity of research conclusions. This article introduced the common methods of confounding factors/covariates control in real-world studies, including hierarchical analysis, analysis of covariance, multi-factor regression, propensity score, disease risk score and instrumental variable analysis, and cases analysis combined with clinical research application of cerebrovascular disease, so as to provide reference for understanding and applying the relevant methods.

Objective To construct and validate a prognosis prediction model and a risk stratification tool for more precise and individualized evaluation of prognosis for patients following resection of esophageal squamous cell carcinoma (ESCC), and provide real-world evidence for informing optimal decision-making about adjuvant therapy. Methods The comprehensive clinical data and follow-up data were collected from consecutive patients with ESCC in the Anyang Cancer Hospital (Anyang center) from May 31, 2011 to July 31, 2018, and in the Cancer Hospital of Shantou University Medical College (Shantou center) from August 1, 2009 to December 31, 2018. Patients from the Anyang center formed the training cohort, and a two-phase selection based on backward stepwise multivariable Cox proportional hazard regression and minimization of AIC was used to construct prediction model for overall survival (OS). Bootstrap with 1 000 resamples was used for internal validation, and cohort from the Shantou center was used for external validation. Furthermore, a risk stratification tool was constructed according to the tertiles of the total points derived from nomogram in the training cohort. Results A total of 4 171 eligible patients were included in the training cohort, and 1 895 patients were included in the validation cohort. The final model incorporated nine variables: age, sex, primary tumor location, T stage, N stage, number of lymph nodes harvested, tumor size, adjuvant treatment, and preoperative hemoglobin level. A significant interaction was observed between N stage and adjuvant treatment (P < 0.001), which means that N+ stage patients were likely to benefit from addition of adjuvant therapy as opposed to surgery alone, but adjuvant therapy did not improve OS for N0 stage patients. The C-index of the model was 0.728 (95% CI: 0.713-0.742) in the training cohort, 0.722 (95% CI: 0.711-0.739) after bootstrapping, and 0.679 (95% CI: 0.662-0.697) in the external validation cohort. Calibration plots demonstrated favorable agreement between model prediction and actual observation for 1-, 3- and 5-year OS. In both training and validation cohorts, this model outperformed the seventh edition of the AJCC TNM (tumor, lymph node, and metastasis) staging system in terms of the accuracy of prognostic prediction (P < 0.05). Moreover, within each TNM staging group, this model achieved ideal risk stratification. Conclusions The prediction model constructed in this study may provide individualized survival prediction for patients with resected ESCC in China. This study also demonstrated that the N stage may be a fundamental determinant in planning postoperative adjuvant therapy for ESCC patients.

实效性临床试验（pragmatic clinical trials，PCT）作为真实世界研究的重要构成，在临床研究设计中越来越受到关注和重视。然而，目前对PCT的理解和应用仍存在的一些误区。因此，本文首先从PCT的概念、研究策划与设计、研究目的、常见的设计类型和核心特征等方面进行阐述，使读者全面和正确地认识PCT。其次，本文详述了PCT的使用范围、基本的统计分析原则与各类型试验设计的分析要求。最后，本文明确了此类研究的报告规范。 Abstract: Pragmatic clinical trials (PCT), as a important component of real-world research, attracted more and more attention in clinical study design. However, there exists some confusions in understanding and application of PCT. Therefore, this article provided technical specifications of PCT in terms of the concept, study planning and design, purpose, design types and core features, to make readers have a comprehensive and correct understanding of PCT; in addition, the application scope, basic statistical analysis principles, analysis requirements for various types of study design, and the report standards of PCT were also elaborated.

Objectives: To study the treatment outcomes of extremely preterm infants., Methods: A retrospective analysis was performed for the clinical data of extremely preterm infants who were admitted to the neonatal intensive care unit of the Third Affiliated Hospital of Zhengzhou University from January 2016 to December 2022. The infants were divided into a non-in-hospital death group and a survival group. SPSS 29.0 was used for data analysis., Results: A total of 422 extremely preterm infants were included, of which 155 were in the non-in-hospital death group and 267 in the survival group. The gestational age, birth weight, cesarean section rate, and proportion of mothers with premature rupture of membranes >18 hours in the non-in-hospital death group were all lower than those in the survival group ( P <0.05). In contrast, the proportions of Apgar score ≤3 at 1 minute, intubation, neonatal respiratory distress syndrome, early-onset sepsis, periventricular-intraventricular hemorrhage (grades III-IV), and pneumorrhagia were higher in the non-in-hospital death group compared to the survival group ( P <0.05)., Conclusions: Low gestational age, low birth weight, the history of birth asphyxia, severe intracranial hemorrhage, and pneumorrhagia may be the main causes of non-in-hospital death in extremely preterm infants, and therefore, perinatal health care should be enhanced to reduce the onset of asphyxia and severe diseases.

Objective: To analyze the related factors of treatment failure in children with acute lymphoblastic leukemia (ALL) in real-world., Methods: The clinical data of 1414 newly diagnosed children with ALL admitted to five hospital in Fujian province from April 2011 to December 2020 were retrospectively analyzed. Treatment failure was defined as relapse, non-relapse death, and secondary tumor., Results: Following-up for median time 49.7 (0.1-136.9) months, there were 269 cases (19.0%) treatment failure, including 140 cases (52.0%) relapse, and 129 cases (48.0%) non-relapse death. Cox univariate and multivariate analysis showed that white WBC≥50×10 9 /L at newly diagnosis, acute T-cell lymphoblastic leukemia (T-ALL), BCR-ABL1 , KMT2A -rearrangement and poor early treatment response were independent risk factor for treatment failure (all HR＞1.000, P < 0.05). The 5-year OS of 140 relapsed ALL patients was only 23.8%, with a significantly worse prognosis for very early relapse (relapse time within 18 months of diagnosis). Among 129 patients died from non-relapse death, 71 cases (26.4%) were died from treatment-related complications, 56 cases (20.8%) died from treatment abandonment, and 2 cases (0.7%) died from disease progression. Among them, treatment-related death were significantly correlated with chemotherapy intensity, while treatment abandonment were mainly related to economic factors., Conclusion: The treatment failure of children with ALL in our province is still relatively high, with relapse being the main cause of treatment failure, while treatment related death and treatment abandonment caused by economic factors are the main causes of non-relapse related death.

Objective: To compare the efficacy and safety of flumatinib (FM) and imatinib (IM) as first-line treatment in newly-diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) in real world., Methods: A total of 84 newly-diagnosed CP-CML patients in our center from December 2019 to December 2022 were retrospectively analyzed. Among them, 32 cases received FM as first-line treatment, and 52 cases received IM. Molecular response (MR), disease progression, survival and incidence of adverse events (AEs) were compared between the two groups., Results: At 3 months of treatment, the incidences of early molecular response (EMR), MR2.0 and MR3.0 were 96.7%, 70.0% and 20.0% in FM group, respectively, which were significantly higher than 77.1%, 29.2% and 0 in IM group (all P < 0.05). At 6, 9 and 12 months of treatment, the incidences of major molecular response (MMR) in FM group were 68.2%, 85.7% and 90.0%, respectively, which were significantly higher than 22.9%, 34.0% and 51.1% in IM group (all P < 0.01). The median time to achieve MMR in FM group was 6(6-9) months, which was significantly shorter than 18(12-22) months in IM group ( P < 0.001). The 3-year progression-free survival rate and 3-year event-free survival rate in FM group were 100% and 68.8%, respectively, while in IM group were 98.1% and 55.8%. There were no significant differences between the two groups ( P >0.05). The incidence of grade 3-4 hematologic AEs in FM group was 21.9%, which was slightly lower than 25.0% in IM group, but the difference was not significant ( P >0.05)., Conclusion: In real clinical practice, FM as first-line treatment achieves MMR earlier than IM, and exhibits good safety profile in newly-diagnosed CML-CP patients, which potentially leads to improved long-term survival and treatment-free remission.

Background and purpose: In clinical studies, checkpoint inhibitor-related pneumonitis (CIP) ranks first among the causes of death in programmed cell death protein-1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitor immune-related adverse events. Real-world CIP situations lack extensive population reports. This study aimed to understand the incidence of CIP in the real world of lung cancer in China, and to summarize its characteristics, treatment status and outcomes. Methods: This study retrospectively collected the essential clinical information of patients with an initral diagnosis of lung cancer who received treatment with immune checkpoint inhibitors (ICIs) at the First Affiliated Hospital of Guangzhou Medical University and Shanghai Pulmonary Hospital between January 2019 and September 2021. For patients with CIP, we also collected the time of its onset, grade, treatment regimen and outcome. The analyses of incidence, patient’s characteristics and the risk factors of CIP in overall and subgroup were carried out. Moreover, we analyzed the outcomes of patients treated with immunosuppressive therapy. Results: A total of 2 031 patients with immunotherapy were enrolled, with a CIP incidence rate of 7.2% (147/2 031), a severe CIP rate of 2.6% (52/2 031) and a mortality rate of 0.4% (9/2 031). The rate of severe grade in the population with CIP was 35.4%, and the mortality rate was 6.1% (9/147). Compared with non-CIP patients, more CIP patients were male, older (>65 years), with combination therapy, and on first- and second-line immunotherapy in advanced treatment. In subgroup analyses, the incidence of CIP was higher in men, the elderly (>65 years), squamous cancer, combination therapy, anti-PD-1 inhibitors, and first- and second-line therapy in advanced treatment. The median onset time of CIP in the real world was 148 days, with a double-peak characteristic, that was, 60-90 days and 150-210 days after immunotherapy were both the peak time periods for CIP onset. The incidence of CIP was also influenced by seasonality, with a high incidence in autumn and winter. All treated patients used corticosteroids as first-line treatment; the immunosuppressive treatment rate of CIP in this study was 76.2%. After treatment, 97.9% of mild CIP patients and 81.2% of severe CIP patients had a good prognosis, and 17.3% of severe CIP patients died due to CIP. Conclusion: In the real world, the incidence of CIP for lung cancer patients was 7.2%, incidence of severe CIP was 2.6%, and mortality rate was 0.4%; the incidence of severe disease in the population with CIP was 35.4%, and mortality rate was 6.1%. The median onset time of CIP was characterized by a double peak, and incidence of CIP was higher in autumn and winter. Men, the elderly, squamous cancer patients, patients on combination therapy, patients who used anti-PD-1 inhibitors, and patients with advanced treatment had higher incidence of CIP. Most patients with CIP had good outcomes after immunosuppressive therapy.

Background Bigu is a health-preserving regimen with a long history advocating appropriately reducing food intake in China, whose efficacy has been confirmed in practical treatment of some diseases currently. However, the applicability of Bigu in human experiments is poor due to nonforcible control of dietary intake in the participants. Objective To assess the effect of medicine-qi intake type of Bigu in healthy people using real-world data. Methods Two hundred and eighty healthy volunteers were recruited from Sichuan Nursing Vocational College from November 2018 to September 2020, and equally divided into two groups (A and B, with 140 cases in each) after being matched using k-nearest neighbor propensity score approach based on their demographics, and received a two-round Bigu trial: in the first round, group A received 10-day diet-restriction type of Bigu, while group B received 10-day medicine-qi intake in combination with diet-restriction type of Bigu. Then, after one-month washout period, the second round was conducted, during which group A received 10-day medicine-qi intake in combination with diet-restriction type of Bigu, while group B received 10-day diet-restriction type of Bigu. Comparisons were performed between two groups in terms of incidence of adverse reactions and number of dropouts in two rounds of Bigu, and subjective hunger sensation, weight, BMI, morning blood pressure, and fasting fingerstick glucose on the first and 10th days of two rounds of Bigu. Results After being assigned by PSM, there were 72 males and 80 females in group A; 61 males and 67 females in group B. In the first round, the incidence of adverse reactions in group A was 65.7% (92/140) , and the trial discontinuation rate was 48.6% (68/140) ; the incidence of adverse reactions in group B was 42.9% (60/140) , and the trial discontinuation rate was 20.0% (28/140) . The incidence of adverse reactions and trial discontinuation rate in group A were higher than those in group B, and the difference was statistically significant (P

Background The Severe Acute Respiratory Syndrome Coronavirus 2 Omicron variant (SARS-CoV-2, Omicron) has been widely spread around the world. Since February 2022, Shenzhen was continuously affected by it as a major hub connecting domestic and international transportation, resulting in rapidly increasing number of infected cases. Objective To construct a modified susceptible-exposed-infected-recovered (SEIR) model for providing policy references and suggestions with applied value for epidemic prevention and control in Shenzhen, China, so as to alleviate the pressure of prevention and control. Methods This study developed a modified SEIR model targeting the epidemiological characteristics of the Omicron variant such as rapid transmission, high concealment, and general susceptibility of the population, introducing groups with policy characteristics as close contacts, secondary contacts, quarantined individuals and carriers, based on traditional SEIR model of infectious disease dynamics. The relevant parameters of the modified model were determined by fitting the Shenzhen epidemic data of February 18 to 28, 2022. Results The predicted data of the model were basically consistent with the actual data from March 01 to 04, 2022, providing a reliable basis for predicting the subsequent development of the epidemic. Subsequently, the Omicron variant outbreak in Shenzhen between 5 to 19 March 2022 was forecasted through this modified model to provide guidance for epidemic prevention and control measures in terms of the degree and time of manual intervention in epidemic prevention and control, and healthcare resource requirements such as patient beds and isolation rooms. Conclusion The modified SEIR model developed in this study has proved its practical value in forecasting epidemic development, formulating and adjusting epidemic control measures, and allocating health resources.

BackgroundThere are differences between RCTs and real-world data in reporting the rate of clinical control of patients with diabetes, which cannot solve the problem of continuous observation in large-scale populations. At present, there is no real-world data cross-sectional survey research and related literature of clinical control indicators of T2DM patients who avoid direct contact with patients and doctors in China.ObjectiveTo explore the clinical control compliance rate of individual and comprehensive indicators in patients with type 2 diabetes mellitus (T2DM) in the real world.MethodsSince 2017, 13 community health service institutions in Wuhou District that have gradually bound the data of the primary care information business system to the EPM through unique ID information were selected as sample areas. T2DM patients with EPM bound in the sample area were selected as the research subjects. The effective follow-up period, within 1 year outside the effective follow-up period, and more than 1 year outside the effective follow-up period of T2DM patients with glycated hemoglobin (HbA1c) , low-density lipoprotein cholesterol (LDL-C) , blood pressure follow-up rate, average level, and clinical control compliance rate were recorded. The follow-up rate of comprehensive indicators of 3B (ie HbA1c, LDL-C, blood pressure) and the rate of clinical control compliance were recorded. The correlation between HbA1c, LDL-C, blood pressure, 3B comprehensive indicators and the number of T2DM patients managed in different community health service institutions, the correlation between the number of patients with HbA1c, LDL-C, blood pressure and the effect of each indicator during the effective follow-up period sex were analyzed.ResultsAmong the 26 501 contracted T2DM patients, the follow-up rates of HbA1c, LDL-C, blood pressure and 3B comprehensive indicators during the effective follow-up period were 43.54% (11 539/26 501) , 45.66% (12 101/26 501) , 89.18% (23 633/26 501) and 32.89% (8 715/26 501) , respectively. The follow-up rates of HbA1c, LDL-C, blood pressure and 3B composite indicators within 1 year outside the effective follow-up period were 15.81% (4 190/26 501) , 24.02 % (6 366/ 26 501) , 9.29 (2 463/26 501) and 0.97% (257/26 501) respectively. The follow-up rates of HbA1c, LDL-C, blood pressure and 3B comprehensive indicators beyond the effective follow-up period for more than 1 year were 19.20% (5 087/26 501) , 23.41% (6 203/26 501) , 1.28% (339/26 501) and 0.49% (131/26 501) , respectively. During the effective follow-up period, the clinical control rates of HbA1c, LDL-C, blood pressure and 3B comprehensive indicators were 60.79% (7 015/11 539) , 59.74% (7 229/12 101) , 52.57% (12 423/23 633) and 18.75% (1 634/8 715) , respectively. The clinical control rate of HbA1c, LDL-C, blood pressure, and 3B comprehensive indicators within 1 year outside the effective follow-up period were 51.98% (2 178/4 190) , 56.75% (3 613/6 366) , 47.79% (1 177/2 463) and 14.79% (38/257) , respectively. The clinical control rates of HbA1c, LDL-C and blood pressure beyond the effective follow-up period for more than 1 year were 65.62% (3 338/5 087) , 59.46% (3 688/6 203) and 22.71% (77/339) , respectively. There was a high correlation between the blood pressure clinical control compliance rate and the 3B comprehensive index clinical control compliance rate (r=0.949, P

Objective: To investigate the efficacy and safety of orelabrutinib combined with R-CHOP in the treatment of MCD subtype diffuse large B cell lymphoma (DLBCL) . Methods: Twenty-three MCD subtype patients whose gene-subtype classification was based on baseline tumor tissue and/or baseline plasma using the LymphGen algorithm from June 2022 to June 2023 in the First Affiliated Hospital of Nanjing Medical University were retrospectively enrolled in the analysis. All patients were treated with R-CHOP or R-miniCHOP in Course 1, OR-CHOP or OR-miniCHOP (21 days for one course) in Courses 2-6, and R-monotherapy in Courses 7-8. Results: Of the 23 patients, the median age was 58 years (range: 30-81 years), and 11 (47.8% ) aged >60 years. Fifteen cases (65.2% ) had international prognostic index (IPI) scores of 3 to 5. The top 10 mutated genes in the gDNA tissues were PIM1 (78.3% ), MYD88 (69.6% ), ETV6 (43.5% ), BTG1 (39.1% ), CD79B (43.5% ), HIST1H1E (39.1% ), BTG2 (34.8% ), KMT2D (30.4% ), CD58 (26.1% ), and CDKN2B (21.7% ). The consistency rate of the tissue and plasma mutations was 80%, while the baseline plasma ctDNA burden was closely correlated with the LDH levels and IPI scores ( P <0.05). All patients received 5 courses of OR-CHOP regimens. The mid-term (after 3 courses) evaluation showed that the overall response rate (ORR) was 100% (23/23), with 22 patients (95.65% ) achieving complete remission (CR), and 1 patient (4.35% ) achieving partial remission (PR). The ORR after the end of treatment (EOT) was 95.65% (22/23). Moreover, 21 patients (91.30% ) obtained CR, 1 patient (4.35% ) obtained PR, and 1 patient (4.35% ) obtained progression disease (PD). Of the 21 patients who had the dynamic EOT-ctDNA burden, only four patients (19.0% ) did not achieve EOT-ctDNA clearance, while the other 17 patients (81.0% ) achieved EOT-ctDNA clearance. The median follow-up time was 20.8 (15.3-30.0) months, while the median progression-free survival (PFS) and overall survival (OS) were not reached. The 2-year PFS rate was 71.8% (95% CI 54.7% -94.2% ), while the 2-year OS rate was 91.3% (95% CI 80.5% -100.0% ). Furthermore, the OR-CHOP regimen was generally well tolerated during clinical use, with hematological toxicity being the main adverse effect. Conclusion: This study revealed that the OR-CHOP regimen can be used as an effective and safe first-line treatment for MCD subtype DLBCL.

In recent years, the rapid development of medical information technology has made it critical to analyze largescale diagnosis and therapeutic data and extract rules based on real medical environment. This has become an essential approach for marketing evaluation and regulatory decision-making of drugs and devices both domestically and internationally. Real world study (RWS), as a novel methodology for clinical evaluation of drugs in the field of drug utilization research (DUR), have presented opportunities and challenges for observational studies in assessing actual efficacy or effectiveness. However, despite being a popular methodological approach among scholars in the field, there are still limitations and deficiencies when analyzing population medication characteristics in RWS. Systematic evaluation research methods have not yet been established, leading to inadequate generation of real-world evidence (RWE). The research design, methodological pathways, evaluation indicators, confounding factors, and bias management involved in DUR based on real-world data (RWD) were reviewed in this artical with the intention of providing guidance for further exploration into DUR. [ABSTRACT FROM AUTHOR]

Objective: To analyze the efficacy and safety of anti-fibrosis therapy in patients with fibrotic interstitial lung disease (FILD) in the real world and the risk factors of disease progression. Methods: Patients who were first diagnosed with FILD and started oral pirfenidone or nintedanib anti-fibrosis treatment were included. The patients were followed up for 2 years. The clinical data of the patients were collected and the baseline characteristics were analyzed, including gender, age, smoking history, basic lung function [forced vital capacity (FVC), diffusing capacity of the lungs for carbon monoxide (DLCO)], complications and shared drugs. Lung function was recorded at the beginning of anti-fibrosis, 12 months and 24 months after anti-fibrosis treatment, and the annual decline rates of FVC and DLCO were analyzed. Drug-related adverse reactions and tolerance were collected.Logistic regression model was established to analyze the relationship between clinical variables and disease progression. Results: After 12 months of anti-fibrosis treatment, there was no significant difference in FVC and DLCO between 167 patients with FILD and before treatment (P>0.05). The FVC and DLCO of 67 patients with FILD decreased after 24 months of anti-fibrosis treatment, but there was no statistical difference (P>0.05). A total of 98 adverse events occurred in 110 patients treated with pirfenidone, and 70 adverse events occurred in 57 patients treated with nintedanib. Only some adverse events led to drug withdrawal. The most common side effect of both anti-fibrosis drugs was diarrhea. Compared with pirfenidone, the discontinuation rate of nintedanib due to adverse events was significantly higher (P<0.05). Logistic regression analysis showed that the risk factors of disease progression within 12 months after anti-fibrosis treatment were smoking and patients with idiopathic pulmonary fibrosis (IPF), while DLCO was a protective factor for disease progression. Conclusion: In the real world, anti-fibrosis therapy can maintain the stability of FVC and DLCO in FILD patients, and the adverse reactions related to anti-fibrosis drugs can be tolerated with high safety. Smoking and IPF patients are more prone to disease progression, and higher DLCO is a protective factor for disease progression in FILD patients. [ABSTRACT FROM AUTHOR]

BackgroundAs the most common chronic disease, hypertension is an important high-risk factor for cardiovascular and cerebrovascular diseases and vascular events. Previous studies have found that acupuncture has the effect of lowering blood pressure, but there is currently a lack of real-world research evidence for acupuncture to lower blood pressure.ObjectiveTo evaluate the blood pressure control effect of Huoxue Sanfeng acupuncture on hospitalized patients with cerebral infarction and hypertension in the real world.MethodsPatients with cerebral infarction and hypertension meeting the inclusion and exclusion criteria in the acupuncture ward of First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from January 2014 to April 2020 were selected. There were 10 781 patiens who met the inclusion and exclusion criteria. According to whether the Huoxue Sanfeng acupuncture method was applied during hospitalization, the patients were divided into basic treatment group (n=10 424) and Huoxue Sanfeng group (n=357) . The propensity score matching (PSM) was used to obtain a new sample with balanced covariates between groups, and the linear mixed effects model was used to compare the average daily blood pressure and morning blood pressure of the two groups in the new sample, which was used to evaluate the effect of Huoxue Sanfeng acupuncture in controlling blood pressure.ResultsThere was no statistically significant difference in gender, age, coronary heart disease, diabetes, atrial fibrillation, the levels of HCY, TC, TG, LDL, and Cr levels before matching (P>0.05) , while the levels of HDL and Ur in basic treatment group were higher than those in the Huoxue Sanfeng group (P0.05) . The results of the linear mixed effect model showed that the average systolic blood pressure in the Huoxue Sanfeng group was lower than the basic treatment group (P=0.002) ; the average level of diastolic blood pressure in the Huoxue Sanfenggroup and the basic treatment group was not statistically significant difference (P=0.083) ; there was no interaction between treatment methods and hospital admission time (P=0.532, P=0.775) . The results of the mixed effect model showed that after the intervention of different treatments, the systolic blood pressure in theHuoxue Sanfenggroup was lower than the basic treatment group in the morning (P=0.012) ; the morning diastolic blood pressure of the Huoxue Sanfenggroup and the basic treatment group was not statistically significant difference (P=0.539) ; there was no interaction between the treatment method and hospital admission time (P=0.974, P=0.985) .ConclusionHuoxue Sanfeng acupuncture can further control the daily average systolic blood pressure and early morning systolic blood pressure in hospitalized patients with cerebral infarction and hypertension.

Objective To compare the efficacy, safety, and survivability of TCbHP versus AC-THP in the neoadjuvant therapy of HER2-positive breast cancer in real-world. Methods Clinical data of patients with HER2 positive breast cancer, who have received TCbHP or AC-THP as neoadjuvant therapy and completed surgery in 11 third-class hospitals in various cities of Hebei Province, were retrospectively collected.The total pathological complete remission (tpCR) rate, the incidence of grade 3 or higher adverse reactions and the completion rate of the given approaches were compared. Results A total of 110 cases were collected, including 78 cases in the TCbHP group and 32 cases in the AC-THP group.The tpCR rate of the TCbHP group was higher than that of the AC-THP group, but the difference was not statistically significant (64.10% vs. 56.25%, P=0.441).No significant difference was found in the breast pathologic complete response (bpCR) and axillary pathologic complete response (apCR) rates between the TCbHP group and the AC-THP group (70.51% vs. 56.25%, P=0.150;78.21% vs. 84.38%, P=0.462).Exploratory analysis revealed that the tpCR rate of the TCbHP group was significantly higher than that of the AC-THP group in patients with HR-positive breast cancer (51.11% vs. 22.22%, P=0.036).As for the patients with HR-negative breast cancer, the tpCR rate of the AC-THP group tended to be higher than that of the TCbHP group (100% vs. 81.82%, P=0.088).The incidence of grade 3 or higher adverse reactions in the TCbHP group was slightly higher than that in the AC-THP group (12.82% vs. 9.38%, P=0.753).No deaths occurred in the whole group.Moreover, no significant difference was observed in the completion rate of the given approaches between the TCbHP group and the AC-THP group (92.31% vs. 90.63%, P=0.718). Conclusion In real-world clinical practice, the neoadjuvant therapy of TCbHP and AC-THP are effective, safe, and well tolerated among patients with HER2-positive breast cancer.The tpCR rate between the two approaches was not significantly different.The AC-THP regimen could also be considered as one of the optimal regimens for HER2-positive breast cancer in neoadjuvant therapy.

Objective: To observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel as first-line treatment for patients with advanced pancreatic cancer in China, and to explore the prognosis-related molecules in pancreatic cancer based on next-generation sequencing (NGS) of tumor tissues. Methods: From December 2018 to December 2020, patients with locally advanced or metastatic pancreatic cancer were recruited to accept albumin-bound paclitaxel as first-line treatment in the oncology departments of 24 hospitals in East China. The primary endpoints were overall survival (OS) and treatment related adverse events, and the secondary endpoint was progression-free survival (PFS). Adverse effects were graded using Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0). NGS sequencing on the primary or metastatic tissue samples of pancreatic cancer obtained through surgical resection or biopsy was performed. Results: This study recruited 229 patients, including 70 patients with locally advanced pancreatic cancer (LAPC) and 159 patients with metastatic pancreatic cancer (mPC). The disease control rate was 79.9% and the objective response rate is 36.3%.The common adverse effects during treatment were anaemia (159 cases), leucopenia (170 cases), neutropenia (169 cases), increased aminotransferases (110 cases), and thrombocytopenia (95 cases), and the incidence of grade 3-4 neutropenia is 12.2% (28/229). The median follow-up time was 21.2 months (95% CI : 18.5-23.1 months). The median PFS (mPFS) was 5.3 months (95% CI : 4.37-4.07 months) and the median OS (mOS) was 11.2 months (95% CI : 9.5-12.9 months). The mPFS of patients with LAPC was 7.4 months (95% CI : 6.6-11.2 months), and their mOS was 15.5 months (95% CI : 12.6-NA months). The mPFS of patients with mPC was 3.9 months (95% CI : 3.4-5.1 months), and their mOS was 9.3 months (95% CI : 8.0-10.8 months). Multivariate Cox regression analysis showed that clinical stage ( HR =1.47, 95% CI : 1.06-2.04), primary tumor site ( HR =0.64, 95% CI : 0.48-0.86), Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ( HR =2.66, 95% CI : 1.53-4.65), and whether to combine radiotherapy ( HR =0.65, 95% CI : 0.42-1.00) were independent influencing factors for the PFS of these patients. The primary tumor site ( HR =0.68, 95% CI : 0.48-0.95), ECOG score ( HR =5.82, 95% CI : 3.14-10.82), and whether to combine radiotherapy ( HR =0.58, 95% CI : 0.35-0.96) were independent influencing factors of the OS of these patients. The most frequent gene mutations in these advanced stage pancreatic patients were KRAS (89.66%), TP53 (77.01%), CDKN2A (32.18%), and SMAD4 (21.84%) by NGS of tumor tissues from 87 pancreatic cancer patients with sufficient specimens. Further analysis revealed that mutations in CDKN2B , PTEN , FGF6 , and RBBP8 genes were significantly associated with an increased risk of death ( P ＜0.05). Conclusion: Albumin-bound paclitaxel as first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety for patients with advanced pancreatic cancer in China.

Objective: To compare the real-world efficacy and safety profile of tenofovir amibufenamid (TMF) and tenofovir alafenamide (TAF) tablets in the treatment of patients with chronic hepatitis B (CHB). Methods: This retrospective study included patients with chronic hepatitis B who received TMF and TAF antiviral treatment at the Infectious Disease Outpatient Department of the First Affiliated Hospital of Zhengzhou University from January 2021 to December 2023. The primary and secondary outcome was to study the patient HBV DNA conversion rate (<20 IU/ml), alanine aminotransferase (ALT) normalization rate, renal function, and lipid levels of patients at 48 weeks of treatment. The comparison of data between measurement data groups was differentiated using a t -test and Mann-Whitney U test. The inter-group comparison rate in count data was performed using the χ 2 test or Fisher's exact probability. Results: A total of 440 cases were enrolled, including 220 in the TMF group (63 treatment-naïve and 157 treatment-experienced) and 220 cases in the TAF group (61 treatment-naïve and 159 treatment-experienced). In terms of efficacy, the HBV DNA seroconversion rates in the TMF group and TAF group were 90.5% and 85.2% ( P =0.372), respectively, while the ALT normalization rates were 92.1% and 88.5% ( P =0.505), respectively, at 48 weeks of treatment. The HBV DNA-negative conversion rate for the newly treated patients was 99.4% and 98.7%, respectively ( P =1.000), while the rates of ALT normalization were 94.9% and 92.3%, respectively ( P =0.863). In terms of safety profile, the serum creatinine level was lower in the TMF group than that in the TAF group at 48 weeks of treatment [TMF group 66.5 (56.3, 78.3) μmol/L, TAF group 70.6 (60.7, 77.8) μmol/L, Z =-2.282, P =0.022]. However, there was no statistically significant difference in other renal function and tubular function related indicators between the two groups of patients ( P >0.05). The serum high-density lipoprotein levels were higher in the TMF group than those in the TAF group [TMF 1.4 (1.1, 1.6) mmol/L vs. TAF group 1.3 (1.1, 1.6) mmol/L, Z =-2.204, P =0.027] at 48 weeks of treatment. However, there was no statistically significant difference in other blood lipid indicators between the two groups of patients ( P >0.05). Conclusion: There is no statistically significant difference in efficacy and safety profiles between TMF and TAF at 48 weeks in the treatment of patients with chronic hepatitis B, and the overall safety profile is favorable.

Objective: To explore the distribution of different biomarkers for Behcet's syndrome (BS) and their correlation with distinct clinical phenotypes of BS patients in real-world studies. Methods: This study was a retrospective cross-sectional study. A total of 483 patients diagnosed with BS in the Department of Rheumatology and Immunology, Peking University People's Hospital from 2019 to 2022 were enrolled. The baseline information and clinical features of the patients were recorded at their first diagnosis and tested the level of HLA-B51, several auto-antibodies, antistreptolysin-O(ASO), immune globulin, complement in blood serum and interleukin-6 (IL-6). Logistic regression was used to analyze the correlation of biomarkers and phenotypes. Results: Among BS patients, the number of positive cases for HLA-B51, anti-endothelial cell antibody (AECA), antinuclear antibodies (ANA) and ASO was 129, 115, 79 and 54, respectively. The positive rate of other biomarkers was less than 5.0%. About 12.6% of patients with BS had an increased level of IgA ( n =61), and 10.8% of patients had an increased level of IgG ( n =52). About 41.0% of patients had increased levels of IL-6 ( n =198), and 6.4% of patients had decreased levels of IgM ( n =31). About 11.2% of patients had decreased levels of C3 ( n =54), and 6.0% of patients had decreased levels of C4 ( n =29). Elevated IgA was a risk factor for the articular phenotype of BS ( OR =2.652, P =0.011). Decreased complement C4 was a risk factor for the neurological phenotype of BS ( OR =3.594, P =0.039). Positive ASO was a risk factor for the gastrointestinal phenotype of BS ( OR =2.578, P =0.041). Elevated IL-6 was a risk factor for the ocular phenotype of BS ( OR =7.560, P =0.016). Conclusion: HLA-B51 and AECA are common biomarkers in BS. Elevated IgA, decreased complement C4, positive ASO, and elevated IL-6 are risk factors for different phenotypes of BS.

Objective To investigate the effectiveness, safety and economy of Qianliexin capsule in the treatment of chronic prostatitis using multi-center and real world research method for providing the guidance for clinical application. Methods A total of 3 399 patients with chronic prostatitis were enrolled from 22 centers across the country. The patients received Qianliexin capsule alone or in addition to their conventional treatment. NIH-CPSI scores were observed and recorded before and after treatment, and change s in total re sponse rate, score halving rate, symptom disappe arance rate and single symptom score we re analyzed. Adverse reactions were observed and abnormal rate of liver and kidney function (ALT/AST/Cr), as well as cost-effectiveness ratio and incremental cost-effectivene ss ratio during treatment cycle were recorded. Results After treatment, the total NIH-CPSI score decreased compared with that before treatment, and the total effective rate was 89.79%, the difference was statistically significant (P <0.001). The overall halving rate of pain or discomfort symptom score was 76.21%, and the overall halving rate of urination symptom score was 78.26%. The overall disappearance rate of pain or discomfort symptom score was 23.36%, and the overall disappearance rate of urination symptom score was 21.77%. The incidence of adverse reactions was 0.47%, and the frequency was rare. No serious adverse reactions were found. In the economic evaluation, the cost-effectiveness ratio of Qianliexin capsule used alone (3.42 yuan/%) was the smallest. Conclusion Qianliexin capsule can significantly improve the pain and discomfort symptoms and urination symptoms of chronic prostatitis patients in real medical scenes, with good safety and high economy. [ABSTRACT FROM AUTHOR]

目的 明确真实世界内蒙古包头地区40岁及以上人群抗血小板聚集类药物的使用情况，以及不同人群服药率的影响因素。 方法 采用以居委会、村委会为单位的多级、整群、随机抽样方法，在2021年6月—2022年9月抽取包头地区40岁及以上常住居民。采用调查问卷形式收集研究对象的一般资料、既往病史及抗血小板聚集类药物使用情况。按照是否有心脑血管疾病（cardio cerebrovascular diseases，CVD）以及是否存在CVD危险因素将研究对象分为3组：CVD组（既往患CVD人群）、CVD危险因素组（无CVD病史，有以下1个或多个CVD危险因素：高血压、糖尿病、高血脂、吸烟史、饮酒史、肥胖）、健康对照组（无CVD病史，无CVD危险因素）。比较3组间一般资料的差异。根据是否服用抗血小板聚集类药物，将CVD组和CVD危险因素组的研究对象分别分为服药组和未服药组，采用单因素和多因素分析调查两组中影响服药的相关因素。 结果 ①研究共纳入2100例有效调查对象，其中CVD组298例（14.2%）、CVD危险因素组1040例（49.5%）、健康对照组762例（36.3%）。3组人群中抗血小板聚集类药物应用率分别为51.68%（154例）、33.46%（348例）和6.69%（51例），组间差异有统计学意义（P＜0.001）。②多因素分析显示，CVD组中较高学历（以小学及以下学历为基线，高中OR 2.429，95%CI 1.277～4.619，P=0.007、本科及以上学历OR 8.500，95%CI 1.015～12.165，P=0.048）以及合并糖尿病（OR 2.820，95%CI 1.377～5.777，P=0.005）的患者更倾向于应用抗血小板聚集类药物；CVD危险因素组中抗血小板聚集类药物应用率受个人经济收入（以＜1.0万/年为基线，＞5.0万/年 OR 18.547，95%CI 8.948～38.444，P＜0.001）、学历（以小学及以下学历为基线，本科及以上学历OR 5.512，95%CI 1.736～17.495，P=0.004）、吸烟史（OR 0.712，95%CI 0.541～0.936，P=0.015）、BMI（与低BMI患者相比，BMI正常OR 5.640，95%CI 1.172～27.144，P=0.031）；肥胖 （OR 8.440，95%CI 1.684～42.293，P=0.009）、患高血压（OR 246.029，95%CI 112.44～538.337， P＜0.001）、患糖尿病（OR 117.689，95%CI 51.041～271.367，P＜0.001）等因素的独立影响。③CVD组和CVD危险因素组的服药原因中医师处方占比最高，分别为83.12%和79.60%；健康对照组服药原因从高到低依次为自觉应该服用（47.06%）、亲友介绍（29.41%）、广告媒体宣传（13.73%）和医师处方（9.80%）。 结论 内蒙古包头地区40岁及以上人群中使用抗血小板聚集类药物进行CVD一级、二级预防的情况不理想，不同人群服药影响因素各不相同，且存在健康人群不规范和错误用药情况。 Abstract: Objective To clarify the use of antiplatelet aggregating drugs in people aged 40 years and above in Baotou area of Inner Mongolia in the real world, and the factors influencing the rate of taking drugs in different populations. Methods A multilevel, whole-group, random sampling method with neighborhood and village committees was used to draw permanent residents aged 40 years and above in Baotou area from June 2021 to September 2022. A questionnaire was used to collect general information, past medical history and the use of anti-platelet aggregating drugs from the study population. The subjects were divided into three groups according to the presence or absence of cardio cerebrovascular diseases (CVD) and the presence of CVD risk factors: CVD group (with previous CVD), CVD risk factor group (no history of CVD, with one or more of the following CVD risk factors: hypertension, diabetes mellitus, hyperlipidemia, history of smoking, history of alcohol consumption, obesity), the healthy control group (no history of CVD, no risk factors for CVD). The differences in general information between the 3 groups were compared. The subjects in the CVD group and the CVD risk factor group were divided into the medication group and the non-medication group according to whether they were taking antiplatelet aggregation drugs or not, and the relevant factors affecting medication taking in the two groups were investigated using univariate and multifactorial analyses. Results ①A total of 2100 validated subjects were included in the study, including 298 cases (14.2%) in the CVD group, 1040 cases (49.5%) in the CVD risk factor group, and 762 cases (36.3%) in the healthy control group.The rates of taking antiplatelet aggregation drugs in the three groups were 51.68% (154 cases), 33.46% (348 cases), and 6.69% (51 cases), respectively, with statistically significant differences between groups (P50 000/year, OR 18.547, 95%CI 8.948-38.444, P

Background The thrombolytic effect for ischemic stroke (IS) is affected by complex factors, such as acute onset of stroke, short therapeutic time window, various individual patient factors, treatment model, types and doses of medicines as well as mode of administration. To identify the influencing factors of thrombolytic effect, most existing studies adopt statistical methods, while rare studies use artificial intelligence (AI) -based algorithms.Objective To establish models using AI-based algorithms for IS patients based on the real-world data including general patient characteristics, medication model and recovery effects, to achieve precise individualized thrombolytic treatment and provide data support for clinical prescription decisions.Methods A retrospective design was used. The clinical information of IS patients (n=55 621) was extracted from the Yidu Cloud scientific research big data server system of the Second Affiliated Hospital of Dalian Medical University from January 1, 2001 to December 31, 2021, among whom 1 855 with complete information were enrolled according to the inclusion criteria. Thrombolysis effect was evaluated by comparing the National Institutes of Health Stroke Scale (NIHSS) score measured at admission and discharge, and those with an improvement in the NIHSS score by ≥4 points and

Background Immunotherapy-related endocrine adverse reactions are relatively common, which often lead to serious outcomes if not treated in time. However, the incidence of immunotherapy-related endocrine adverse reactions varies widely in previous literature reports without standard processing. Objective To investigate the occurrence and treatment process of endocrinologic adverse reactions caused by immune checkpoint inhibitors (ICIs) in the real world. Methods The clinical data of 204 patients with solid tumors treated with ICIs at the Third People's Hospital of Zhengzhou from January 2019 to March 2022 was retrospectively analyzed, the endocrinologic adverse reactions occured their treatment were observed and standardized management was conducted according to the adverse reactions grading. Results A total of 204 patients with solid tumors were included, involving 139 male patients and 65 female patients, with a median age of 65.4 (8.0, 88.4) years. The types of solid tumor were predominantly non-small cell lung cancer (43.1%) , the treatment drugs were mainly sindilizumab (47.1%) , and the treatment patterns were predominantly immunotherapy combined with targeted agents (57.4%) . 12 patients developed ICIs-related endocrinologic adverse reactions, including 9 cases (4.4%) of hypothyroidism (1 case of gradeⅠ, 7 cases of grade Ⅱ, 1 case of grade Ⅲ) with the median onset time of 7 (6, 10) weeks after the treatment of immunological drugs, 1 case (0.5%) of hyperthyroidism (gradeⅠ) occurred 9 weeks after the immunotherapy, 1 case (0.5%) of type 1 diabetes (gradeⅣ) occurred 6 weeks after auto-immunotherapy, 1 case (0.5%) of adrenal dysfunction (gradeⅢ) occurred 7 weeks after immunotherapy. All the 12 patients with endocrinologic adverse reactions were treated in time according to the hierarchical management process, and all their symptoms were improved or returned to normal, and continued to be treated with ICIs. Conclusion The risk of endocrinologic adverse reactions in the endocrine system is relatively high during the use of ICIs, especially abnormal thyroid function, which requires regular detection of endocrine indicators during treatment, timely intervention will not affect the subsequent treatment of ICIs.

Objective: To evaluate the efficacy and safety of tislelizumab combined with chemotherapy as first ⁃line treatment for locally advanced or metastatic squamous non ⁃ small ⁃ cell lung cancer in the real ⁃world. Methods: A total of 109 patients with lung squamous cell carcinoma were included in the Affiliated Hospital of Inner Mongolia Medical University from January 2021 to December 2023, of whom 66 patients in the tislelizumab combined with chemotherapy group and 43 patients in the chemotherapy group. The objective response rate (ORR), progression⁃free survival (PFS), overall survival (OS) and the incidence of treatment related adverse events (TRAEs) of the two groups were evaluated. Results: At a median follow⁃up of 20.2 months, the ORR of the tislelizumab combined with chemotherapy group was significantly higher than that of the chemotherapy group (75.8% vs. 51.2%) . The median PFS prolonged significantly in the tislelizumab combined with chemotherapy group compared to the chemotherapy group (17.3 months vs. 9.3 months) . OS data were not reached in the tislelizumab combined with chemotherapy group, which was significantly longer than the chemotherapy group (19.3 months, HR=0.38, 95%CI: 0.19-0.68, P=0.002) . The incidence of overall TRAEs and TRAEs above grade 3 in the two groups was similar. The incidence of immune⁃related adverse events (irAEs) in the tislelizumab combined chemotherapy group was 28.8%, including one case (1.5%) of grade 3 and above immune⁃associated pneumonia. Conclusion: Tislelizumab combined with chemotherapy as first⁃line treatment significantly improves the efficacy and manageable safety/tolerability profile in patients with locally advanced or metastatic lung squamous cell carcinoma. [ABSTRACT FROM AUTHOR]

Objective To evaluate the efficacy and safety of endovascular treatment for acute ischemic stroke caused by large vessel occlusion of posterior circulation in the real world. Methods The baseline and clinical data of stroke patients with posterior circulation occlusion who received emergency endovascular treatment (EVT) at 9 stroke centers in the Southwest China from January 2018 to August 2020 were collected and retrospectively analyzed. The main observation indicators included modified Rankin Scale (mRS) score at 90 d, postoperative modified Thrombolysis in Cerebral Infarction (mTICI) score, symptomatic intracranial hemorrhage (sICH), etc. The enrolled patients were divided into good prognosis group (mRS ≤2) and poor prognosis group (mRS >2) according to their mRS score in 90 d postoperatively. Student's t test and Chi-square analysis were employed to compare the differences in baseline and clinical data between the 2 groups, and the results were further analyzed in subgroups. Results A total of 108 patients were enrolled in this study. In 90 d after treatment, the ratio of good prognosis was 43.5% (47/108), mortality rate 25.9% (28/108), vessel recanalization rate 95.4% (103/108), and sICH rate 8.3% (9/108). There were significant differences between the 2 groups in preoperative Posterior circulation Alberta Stroke Program Early CT Score (Pc-ASPECTS), National Institutes of Health Stroke Scale (NIHSS) score, Glasgow Coma Scale (GCS) score, Basilar Artery on Computed Tomography Angiography (BATMAN) score, vessel recanalization rate and sICH rate (P < 0.05). The results of subgroup analysis suggested that the patients with a shorter recanalization time had a higher rate of good prognosis (P < 0.05), and those with good recanalization had lower mortality rate (P < 0.05). Conclusion In the real world, endovascular treatment for large-vessel occlusive stroke in the posterior circulation is safe and effective. Rapid recanalization of occlusive vessels is beneficial to improve the clinical prognosis and reduce mortality.

Objective To understand the current situation of a patient management service and evaluate its effect in direct-to-patient (DTP) pharmacies. Method This is a retrospective cohort study using real-world data routinely collected from DTP pharmacies. A cohort of lung cancer patients using PD-1/L1 was retrospectively established using sales and follow-up data which were collected from 79 Medbanks DTP pharmacies during their daily business activities. Cox regression analysis was used to explore the factors associated with the durations of drug purchase and follow-up. Result A total of 12,226 subjects were included in this study, 76.4% of them were male, with a median age of 62 years. Across the total study population, 1,902 (15.56%) were described as low follow-up response rate group, 1,448 (11.84%) were described as middle follow-up response rate group and 8,876 (72.60%) as high follow-up response rate group. Statistically significant differences were observed in both median drug purchase duration and follow-up duration across the three groups. Findings from Cox regression analysis indicated that factors associated with longer duration of drug purchase included participating a patient access program (HR=0.873, P

ObjectiveTo systematically evaluate the safety of interferon β-1a for treatment of corona virus disease 2019 （COVID-19）， and to provide references for interferon β-1a's clinical application.MethodsThis study was conducted with the database from US Food and Drug Administration adverse event reporting system （FAERS） from January 1， 2015 to March 31， 2021. Information component （IC） and reporting odds ratio （ROR） methods were applied for signal mining.ResultsA total of 463 700 records of COVID-19 were selected for analysis， and 45 positive drug adverse event signals were detected. Headache （IC025=1.09， ROR025=2.28）， pyrexia （IC025=0.51， ROR025=1.51） and multiple sclerosis relapse （IC025=3.67， ROR025=14.71） were positive adverse events with higher frequency. Autoimmune disorder （IC025=4.42， ROR025=24.03）， streptococcal infection （IC025=4.12， ROR025=19.82）， and multiple sclerosis relapse （IC025=3.67， ROR025=14.71） were positive adverse events. Acute lung injury， cardio-respiratory arrest and metabolic acidosis were associated with a higher proportion and frequency of death.ConclusionThere are certain safety issues with interferon β-1a in the treatment of COVID-19， and some adverse events with high frequency and high death rate deserve further attention by medical staffs.

Objective: To assess the safety of sitagliptin added to metformin on cardiovascular adverse events in real world patients with type 2 diabetes mellitus (T2DM)., Methods: Real world data from Yinzhou Regional Health Care Database were used to select T2DM patients with diagnosis and treatment records in the platform from January 1, 2017 to December 31, 2022. According to drug prescription records, the patients were divided into metformin plus sitagliptin group (combination group) and metformin monotherapy group(monotherapy group). A series of retrospective cohorts were constructed according to the index date.Finally, full retrospective cohorts were constructed according to propensity score model, including baseline covariates that might be related to outcomes, to match the subjects in the combination group and monotherapy group for the purpose of increasing the comparability of baseline characteristics. The participants were followed up from the index date until the first occurrence of the following events: Diagnosis of outcomes, death, or the end of the study period (December 31, 2022). Cox proportional risk model was used to estimate the hazard ratio( HR )and 95% confidence interval ( CI ) of sitagliptin added to metformin on 3-point major adverse cardiovascular events (3P-MACE) combination outcome and secondary cardiovascular outcomes., Results: Before propensity score matching, the proportion of the patients in combination group using insulin, α glucosidase inhibitors, sodium-glucose transporter 2 inhibitors (SGLT-2I) and glienides at baseline was higher than that in monotherapy group, and the baseline fasting blood glucose (FBG) and hemoglobin A1c (HbA1c) levels in combination group were higher than those in monotherapy group. After propensity score matching, 5 416 subjects were included in the combination group and the monotherapy group, and baseline characteristics were effectively balanced between the groups. The incidence densities of 3P-MACE were 6.41/100 person years and 6.35/100 person years, respectively. Sitagliptin added to metformin did not increase or decrease the risk of 3P-MACE compared with the metformin monotherapy ( HR =1.00, 95% CI : 0.91-1.10). In secondary outcomes analysis, the incidence of cardiovascular death was lower in the combination group than in the monotherapy group ( HR =0.59, 95% CI : 0.41-0.85), and no association was found between sitagliptin and the risk of myocardial infarction and stroke ( HR =1.12, 95% CI : 0.89-1.41; HR =0.99, 95% CI : 0.91-1.12)., Conclusion: In T2DM patients in Yinzhou district of Ningbo, compared with metformin alone, sitagliptin added to metformin may reduce the risk of cardiovascular death, and do not increase the incidence of overall cardiovascular events. The results of this study can provide real-world evidence for post-marketing cardiovascular safety evaluation of sitagliptin.

Background and objective Immune-related adverse events (irAEs) are commonly occurred in patients treated with immune checkpoint inhibitors. However, evidence of irAEs derived from the Chinese population is relatively lacking. The aim of this study was to investigate the incidence and outcomes of irAEs in Chinese patients with lung cancer after receiving immune checkpoint inhibitors (ICIs). Methods Clinical and follow-up data from lung cancer patients who received at least one time of ICIs from January 2018 to September 2021 at Huadong Hospital, Fudan University were included. Statistical descriptions and Kaplan-Meier method were used to analyze the overall incidence of irAEs, as well as the incidence and outcomes of each type of irAEs. Results 135 patients were included in the study. 106 patients (78.5%) presented at least one type of irAEs, and the median time to first irAEs onset was 28 d. Most irAEs occurred at early time after treatment, and most irAEs were mild-moderate and reversible. 57 patients (42.2%) died at the study cutoff. The mortality rate of severe irAEs was 12.6% (n=17), and among them 7 patients (41.2%) died of pneumonitis. The median progression-free survival (PFS) and overall survival (OS) time of the total population was 505 d (95%CI: 352-658) and 625 d (95%CI: 491-759), respectively. Patients who presented any irAEs achieved a longer PFS than those who did not (median PFS: 533 d vs 179 d, P=0.037, HR=0.57), while patients who presented skin toxicities achieved a longer OS than patients who did not (median OS: 797 d vs 469 d, P=0.006, HR=0.70). Conclusion In real-world settings, irAEs in lung cancer patients were commonly observed, with pneumonitis as the most common fatal irAEs. In addition, patients who presented any irAEs may tend to achieve a longer PFS.

Background and objective Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) is the first choice for first-line treatment of advanced patients with EGFR positive non-small cell lung cancer (NSCLC). For advanced NSCLC patients with negative drive gene and positive programmed cell death ligand 1 (PD-L1) or highly expressed NSCLC patients, the first-line treatment recommends immune checkpoint inhibitors (ICIs) monotherapy or ICIs combined chemotherapy. Therefore, the first-line treatment strategy for advanced NSCLC patients with EGFR positive at different PD-L1 expression levels is worth further exploring. Many previous studies have suggested that the expression of PD-L1 is obviously affected by EGFR mutation, and the expression of PD-L1 is likely to be related to the mechanism of EGFR-TKIs resistance. The purpose of this study was to analyze the expression characteristics of PD-L1 in patients with advanced EGFR positive NSCLC and its relationship with the efficacy of EGFR-TKIs. Methods 159 patients with newly diagnosed advanced NSCLC with EGFR positive (including 141 patients with EGFR sensitive mutations) were enrolled to analyze the relationship between clinicopathological characteristics and PD-L1 expression. The factors affecting the therapeutic effect of EGFR-TKIs in 141 patients with EGFR sensitive mutations were also explored. Results The PD-L1 expression of the included patients was classified according to the tumor promotion score (TPS): negative (TPS