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Objective: To retrospectively analyze the pregnancy outcomes of patients with adenomyosis requiring fertility in a single center under real world condition. Methods: From June 2015 to May 2020, 231 cases of pregnancy complicated with adenomyosis diagnosed by ultrasound with fertility requirements were treated in the Women's and Children's Hospital Affiliated to Qingdao University with complete clinical data. And they were divided into three groups according to the treatment of adenomyosis before pregnancy: expectation group, drug group and operation group. The relevant data before pregnancy of the three groups were analyzed, and the pregnancy outcomes of the patients were summarized. According to whether the early pregnancy was treated with medication, the patients who were naturally conceived without symptoms of threatened abortion were divided into observation group and fetus protection group, and the pregnancy outcomes of the two groups were compared. Results: (1) Compared with the expectation group, the ages of patients in the drug group and the operation group were larger [(31.5±1.8) vs (34.1±3.7) vs (36.9±3.6) years old], and the difference was statistically significant ( P <0.05). Only 9 patients (11.5%, 9/78) had clinical symptoms in the expectation group, while the patients in the drug group and the operation group had a higher proportion of dysmenorrhea and increased menstrual volume. The uterine volume of the drug group and the operation group were larger than that of the expectation group [(151±46) vs (166±27) vs (97±18) cm 3 ], the difference was statistically significant ( P <0.05). 78.6% (33/42) of the operation group were focal adenomyosis. The proportion of natural pregnancy in the expectation group was 97.4% (76/78), and in vitro fertilization and embryo transfer was mainly used in the drug group and the operation group. (2) The abortion rates of the three groups were 48.7% (26/111), 4/17, 67.5% (27/78) respectively. Compared with the drug group and the operation group, the preterm birth rate was lower [55.9% (33/111) vs 11/17 vs 12.5% (5/78)] and the natural delivery rate was higher [44.1% (26/111) vs 4/17 vs 67.5% (27/78)] in the expectation group. (3) There were 89 cases of spontaneous pregnancy without threatened abortion symptoms, including 31 cases in the observation group and 58 cases in the fetus protection group. Compared with the observation group, the abortion rate of patients in the fetus protection group was lower [41.9% (13/31) vs 34.5% (20/58)], and the difference was statistically significant ( P <0.05). Conclusions: Patients with adenomyosis who have fertility requirements should be comprehensively evaluated and individualized treatment plans should be given. Pregnancy patients with adenomyosis have a high rate of miscarriage, and they should be included in the management of high-risk pregnant women. Active fetal protection treatment during early pregnancy might improve pregnancy outcomes.

How the brain perceives objects and classifies perceived objects is one of the important goals of visual cognitive neuroscience. Previous research has shown that when we see objects, the brain's ventral visual pathway recognizes and classifies them, leading to different ways of interacting with them. In this paper, we summarize the latest research progress of the ventral visual pathway related to the visual classification of objects. From the perspective of the neural representation of objects and its underlying mechanisms in the visual cortex, we summarize the current research status of the two important organizational dimensions of object animacy and real-world size, provide new insights, and point out the direction of further research.

Objective: To explore the efficacy and safety of real-world eribulin in the treatment of metastatic breast cancer. Methods: From December 2019 to December 2020, patients with advanced breast cancer were selected from Beijing Chaoyang District Sanhuan Cancer Hospital, Shandong Cancer Hospital, Peking University Cancer Hospital, Baotou Cancer Hospital, Shengjing Hospital Affiliated to China Medical University, and Cancer Hospital of Chinese Academy of Medical Sciences. Kaplan-Meier method and Log rank test were used for survival analysis, and Cox regression model was used for multivariate analysis. Results: The median progression-free survival (PFS) of 77 patients was 5 months, the objective response rate (ORR) was 33.8%, and the disease control rate (DCR) was 71.4%. The ORR of patients with triple-negative breast cancer was 23.1%, and the DCR was 57.7%; the ORR of patients with Luminal breast cancer was 40.0%, and the DCR was 77.8%; the ORR of patients with HER-2 overexpression breast cancer was 33.3%, and the DCR was 83.3%. ORR of 50.0% and DCR of 66.7% for patients treated with eribulin as first to second line treatment, ORR of 29.4% and DCR of 76.5% for patients treated with third to fourth line and ORR of 28.6% and DCR of 71.4% for patients treated with five to eleven line. The ORR of patients in the eribulin monotherapy group was 40.0% and the DCR was 66.0%; the ORR of patients in the combination chemotherapy or targeted therapy group was 22.2% and the DCR was 81.5%. Patients with a history of treatment with paclitaxel, docetaxel, or albumin paclitaxel during the adjuvant phase or after recurrent metastasis had an ORR of 32.9% and a DCR of 69.9% when treated with eribulin. The treatment efficacy is an independent prognostic factor affecting patient survival ( P <0.001). The main adverse reactions in the whole group of patients were Grade Ⅲ-Ⅳ neutrophil decline [29.9% (23/77)], and other adverse reactions were Grade Ⅲ-Ⅳ fatigue [5.2% (4/77)], Grade Ⅲ-Ⅳ peripheral nerve abnormality [2.6% (2/77)] and Grade Ⅲ-Ⅳ alopecia [2.6% (2/77)]. Conclusions: Eribulin still has good antitumor activity against various molecular subtypes of breast cancer and advanced breast cancer that has failed multiple lines of chemotherapy, and the adverse effects can be controlled, so it has a good clinical application value.

Objective: To explore the effect of primary and acquired resistance to anti-human epidermal growth factor receptor 2 (HER-2) on the overall survival of patients with HER-2 positive advanced breast cancer. Methods: The clinical characteristics of HER-2 positive patients with advanced breast cancer admitted to Cancer Hospital of Chinese Academy of Medical Sciences from January 1998 to December 2018 were collected, and their neoadjuvant/adjuvant and advanced three-line chemotherapy were summarized. Among them, targeted drugs for HER-2 included trastuzumab, pertuzumab, T-DM1, RC48-ADC, lapatinib, pyrotinib, allitinib, sipatinib, seratinib. Based on the duration of benefit from anti HER-2 treatment, the patients were divided into two groups: primary anti HER-2 resistance group and acquired anti HER-2 resistance group. In this study, the overall survival (OS) was used as the main end point. Kaplan-Meier analysis and Cox proportional risk regression model were used to analyze the effects of different drug resistance mechanisms on the overall survival. Results: The whole group of 284 patients were included. The median age of recurrence and metastasis was 48 years old, 155 (54.6%) were hormone receptor (HR) positive and 129 (45.4%) were HR negative, 128 cases (45.1%) were premenopausal and 156 cases (54.9%) were postmenopausal, 277 cases (97.5%) had a score of 0-1 in ECoG PS and 7 cases (2.5%) had a score of more than 2 in the first diagnosis of relapse and metastasis. There were 103 cases (36.3%) in the primary drug resistance group and 181 cases (63.7%) in the secondary drug resistance group. The median overall survival time of the two groups was 24.9 months and 40.4 months, respectively, with statistical significance ( P <0.001). Conclusion: Primary resistance to HER-2 is one of the factors of poor prognosis in HER-2 positive breast cancer, and its mechanism needs to be further explored.

Objective: To evaluate the real-world efficacy and safety of sofosbuvir and velpatasvir (SOF/VEL) tablets in the treatment of Chinese patients with chronic HCV infection. Methods: An open-label, single-center, prospective clinical study was conducted in a county in northern China. A total of 299 cases were enrolled. Of these, 161 cases with chronic hepatitis C and 73 cases with compensated cirrhosis received SOF/VEL for 12 weeks. 65 cases with decompensated cirrhosis received SOF/VEL combined with ribavirin for 12 weeks (22 cases) or SOF/VEL for 24 weeks (43 cases). Virological indicators, liver and renal function indexes, and liver stiffness measurement were detected at baseline, the fourth week of treatment, the end of treatment, and the 12-weeks of follow-up. Adverse reactions and laboratory abnormalities were observed during the course of treatment . The primary endpoint was undetectable rate of HCV RNA (SVR12) at 12 weeks of follow-up with the use of modified intention-to-treat (mITT) approach. Measurement data between two groups were compared using t-test. One Way ANOVA was used for comparison between multiple groups. Enumeration data were analyzed by chi-square test or Fisher's exact test. Results: 291 cases had completed treatment. HCV RNA was undetectable after 12 weeks of follow-up, and the SVR12 rate was 97.3% (95% confidence interval: 95.4%-99.3%). Among them, 97.4% of genotype 1b, 96.4% of genotype 2a, and 100% of those with undetected genotype achieved SVR12. The SVR12 rates in patients with chronic hepatitis C, compensated and decompensated liver cirrhosis were 98.1%, 98.6% and 93.8%, respectively. An improvement in alanine aminotransferase, aspartate aminotransferase and other liver biochemical indicators accompanied with virological clearance and reduced liver stiffness measurement was observed in patients with compensated cirrhosis, with statistically significant difference. There was no significant abnormality in renal function before and after treatment. The most common adverse reactions were fatigue, headache, epigastric discomfort and mild diarrhea. The overall adverse reactions were mild. One patient died of decompensated liver cirrhosis combined with massive upper gastrointestinal bleeding, which was unrelated to antiviral treatment. Four patients discontinued treatment prematurely due to adverse events. Relapse was occurred in four cases, and drug-resistance related mutations were detected in three cases. Conclusion: Sofosbuvir and velpatasvir tablets in Chinese HCV-infected patients with different genotypes, different clinical stages or previously treated with pegylated interferon combined with ribavirin resulted in higher SVR12, indicating that the treatment safety profile is good.

Objective: To investigate the influenza and pneumonia vaccination rates in patients with chronic obstructive pulmonary disease (COPD), and analyze the factors affecting vaccination. Methods: Totally 4 016 COPD patients at the initial visit were included in the Respiratory Department of Xiangya Second Hospital of Central South University from December, 2016 to December, 2019. Each patient's vaccination status after the visit for 1 year was reviewed, and finally 3 177 patients were included in the analysis. Relevant factors affecting vaccination were analyzed with logistic regression. Results: The overall vaccination rates of COPD patients with influenza vaccine, pneumonia vaccine and influenza combined pneumonia vaccine were 2.3% (72/3 177), 1.1% (34/3 177) and 1.1% (34/3 177), respectively. The influenza vaccination rate of urban patients (3.3%, 41/1 252) was higher than that of rural patients (1.6%, 31/1 925, P =0.002). The rates of influenza vaccine, pneumonia vaccine and influenza combined pneumonia vaccine in ex-smokers with COPD were 3.3% (33/993), 2.1% (21/993), 2.1% (21/993), respectively and 1.7% (25/1 467), 0.7% (11/1 467), 0.7% (11/1 467), in current smokers with COPD, respectively ( P =0.034, P =0.015, P =0.015, respectively). The influenza vaccination rate was higher in patients with COPD assessment test (CAT) scored less than 10 (4%, 27/673) than patients with CAT scored more than 10 (1.8%, 45/2 504, P =0.002). In a multifactor analysis, patients who lived in country side, were current smokers, and had more symptoms were less likely to be vaccinated, with an aOR 1.73(95% CI 1.02-2.93), 2.10(95% CI 1.18-3.76), 2.06(95% CI 1.24-3.43), respectively. 81.2% of COPD patients did not receive the vaccine because they did not know the vaccine. Conclusions: Vaccination rates for influenza vaccine, pneumonia vaccine and both of them in COPD patients were low and the patients lacked knowledge of vaccine. The residence, smoking status and symptoms were related to the vaccination of COPD patients, and these should be taken into account in the vaccination health education.

From the perspective of data users, ensuring the relevance and reliability of big data in healthcare and medicine via assessments on data appropriateness is a prerequisite for generating high-quality real-world evidence, which could guarantee good representativeness and generalizability of real-world studies. This review summarized the quality dimensions, definitions, evaluation indexes and calculating methods of assessment on the appropriateness of real-world data (RWD) according to guidance from different countries and international organizations, as well as exploring the opportunities and challenges for better assessing RWD appropriateness.

Objective: To provide reference and evidence for clinical application of neoadjuvant immunotherapy in patients with colorectal cancer through multicenter large-scale analysis based on real-world data in China. Methods: This was a retrospective multicenter case series study. From January 2017 to October 2021, data of 94 patients with colorectal cancer who received neoadjuvant immunotherapy in Peking University Cancer Hospital (55 cases), Union Hospital of Tongji Medical College of Huazhong University of Science and Technology (19 cases), Sun Yat-sen University Cancer Center (13 cases) and Changhai Hospital of Navy Medical University (7 cases) were retrospectively collected, including 48 males and 46 females. The median age was 58 years. Eighty-one cases were rectal cancer and 13 cases were colon cancer (2 cases of double primary colon cancer). Twelve cases were TNM staging II and 82 cases were stage III. Forty-six cases were well differentiated, 37 cases were moderately differentiated and 11 cases were poorly differentiated. Twenty-six patients (27.7%) with mismatch repair defects (dMMR) and microsatellite instability (MSI-H) were treated with immunotherapy alone, mainly programmed cell death protein-1 (PD-1); sixty-eight cases (72.3%) with mismatch repair proficient (pMMR) and microsatellite stability (MSS) were treated with immune combined with neoadjuvant therapy, mainly CapeOx (capecitabine+oxaliplatin) combined with PD-1 antibody plus long- or short-course radiotherapy, or PD-1 antibody combined with cytotoxic T lymphocyte associated antigen 4 (CTLA-4) antibody. Analysis and evaluation of adverse events during neoadjuvant immunotherapy were performed according to the National Cancer Institute Common Toxicity Standard version 3.0; the surgical complications were evaluated according to the Clavien-Dindo grading standard; the efficacy evaluation of neoadjuvant immunotherapy included the following indicators: major pathological remission (MPR) was defined as tumor regression induced by neoadjuvant therapy in pathology residual tumor ≤10%; pathological complete response (pCR) was defined as tumor regression induced by neoadjuvant therapy without residual tumor in pathology; the tumor response rate was disease control rate (DCR), namely the proportion of complete response (CR), partial response (PR) and stable disease (SD) in the whole group; the objective response rate (ORR) was CR+PR. Results: The median cycle of neoadjuvant immunotherapy was 4 (1-10) in whole group, and the incidence of immune-related adverse reactions was 37.2% (35/94), including 35 cases (37.2%) of skin-related adverse reactions, 21 cases (22.3%) of thyroid dysfunction and 8 cases (8.5%) of immune enteritis, of which grade III or above accounted for 1.1%. The median interval between completion of neoadjuvant therapy and surgery was 30 (21-55) days. There were 81 cases of radical resection of rectal cancer, 11 cases of radical resection of colon cancer, and 2 cases of colon cancer combined with other organ resection. The primary tumor resection of all the patients reached R0. The incidence of surgical-related complications was 22.3% (21/94), mainly anastomotic leakage (4 cases), pelvic infection (4 cases), abdominal effusion (3 cases), anastomotic stenosis (3 cases ) and abdominal and pelvic hemorrhage (2 cases). Grade I-II complications developed in 13 cases (13.8%), grade III and above complications developed in 8 cases (8.5%), no grade IV or above complications were found. During a median follow-up of 32 (1-46 ) months, DCR was 98.9% (93/94), ORR was 88.3 % (83/94), pCR was 41.5% (39/94), MPR was 60.6% (57/94). The pCR rate of 26 patients with dMMR and MSI-H undergoing simple immunotherapy was 57.7% (15/26), and MPR rate was 65.4% (17/26). The pCR rate of 68 pMMR and MSS patients undergoing combined immunotherapy was 35.3%(24/68), and MPR rate was 58.8% (40/68). Conclusions: Neoadjuvant immunotherapy has favorable tumor control rate and pathological remission rate for patients with initial resectable colorectal cancer. The incidences of perioperative adverse reactions and surgical complications are acceptable.

Objective: To investigate the relationship between the mechanical circulatory support (MCS) combined with immunomodulation and the prognosis of patients with fulminant myocarditis. Methods: This is a retrospective study. A total of 88 patients with fulminant myocarditis admitted to Dongguan Kanghua hospital from Aug. 2008 to Dec. 2020 were included. Medical histories, results of laboratory tests, treatment regimens and clinical outcomes of these patients during their hospitalization were collected from the medical record system. According to the treatment methods, the patients were divided into MCS+immunomodulation group (38 cases), MCS group (20 cases) and traditional treatment group (30 cases). Patients in the MCS+immunomodulation group received intra-aortic balloon pump (IABP) or IABP combined with extracorporeal membrane oxygenation (ECMO) and immunoglobulin or glucocorticoid. Patients in the MCS group only received mechanical circulatory support. Patients in the traditional treatment group received neither mechanical circulatory support nor immunomodulatory therapy, and only used vasoactive drugs and cardiotonic drugs. The in-hospital mortality and length of stay were compared among the three groups. Results: A total of 88 patients with fulminant myocarditis aged (35.0±10.8) years were included, and there were 46 males (52.3%). The mortality of MCS+immunomodulation group (7.9% (3/38) vs. 56.7% (17/30), P =0.001 2) and MCS group (30.0% (6/20) vs. 56.7% (17/30), P =0.002 8) were lower than that of traditional treatment group. Compared with the MCS group, the in-hospital mortality in the MCS+immunomodulation group was lower ( P =0.005 4). The most common cause of death was multiple organ dysfunction syndrome (MODS). The constituent ratios of death in MCS+immunomodulation group, MCS group and traditional treatment group were 3/3, 4/6 and 12/17, respectively. The incidence of MODS in the MCS group (20% (4/20)) and the traditional treatment group (40% (12/30)) was significantly higher than that in the MCS+immunomodulation group (7.9% (3/38)) (both P <0.01). In discharged patients, the hospitalization time of MCS+immunomodulation group was shorter than that of traditional treatment group ((13.4±5.5)d vs. (18.5±7.4)d, P <0.05) and MCS group ((13.4±5.5)d vs. (16.9±8.5)d, P <0.05). Conclusion: MCS combined with immunomodulatory therapy is associated with lower in-hospital mortality and shorter hospital stay in patients with fulminant myocarditis.

In recent years, as a powerful supplement to the randomized controlled trial (RCT), real world study (RWS) has received more and more attention. However, in the field of chronic wounds, most of the patients have complex condition, and the strict inclusion and exclusion criteria of RCT were lack of practical application values. The RWS provides data closer to the real medical environment in clinical medical practice, drug and medical device supervision, and health technology evaluation. However, RWS has some problems that need to be resolved, such as inconsistent diagnostic criteria and unclear research endpoints. In addition, RWS in chronic wound research in China seems to have not really started yet, and institutions at all levels need to work together to promote the development of RWS.

Objective: This study aimed to look into the clinical characteristics and prognosis of patients with human immunodeficiency virus (HIV) -associated diffuse large B-cell lymphoma (DLBCL) . Methods: Retrospective review of the clinical data of 63 HIV-infected patients with DLBCL diagnosed at Chongqing University Cancer Hospital between July 2008 and August 2021. The Kaplan-Meier method was used to calculate survival curves, and the log-rank test method was used to compare survival between groups. The Cox proportional hazards model was used for multivariate analysis. Results: In 63 patients with HIV-associated DLBCL, 57 (90.5% ) were men, and the median age was 49 (23-87) years. The most common pathological subtype was the germinal center B-cell-like lymphoma (74.6% ) ; 46.0% (29/63) were combined with extranodal lesions. Seventeen of 63 (27.0% ) patients had large masses (≥7.5 cm) . Twenty of 63 (31.7% ) patients had B symptoms. The median CD4(+) T cell count was 203 (4-1022) ×10(6)/L. A total of 49% (25/51) patients had CD4(+) cell count <200×10(6)/L, 56.9% (33/58) had high (3-5) International Prognostic Index (IPI) scores, and 43.1% (25/58) had low (0-2) IPI scores. Further, 78% (46/59) were diagnosed with Ann Arbor Stage Ⅲ/Ⅳ, and 25.4% (16/63) didn't receive chemotherapy. A total of 22.2% (14/63) of patients received less than four cycles of chemotherapy, and 52.4% (33/63) received four or more cycles of chemotherapy. Among patients undergoing chemotherapy, 61.7% (29/47) received R-CHOP-like regimens, and 38.3% (18/47) used CHOP-like regimens. The 1-, 2-, 3-, and 5-year overall survival (OS) rates were 65.0% , 53.8% , 47.1% , and 43.5% , respectively. Univariate analysis revealed that age ≥ 60 years ( P =0.012) , Eastern Cooperative Oncology Gruop Performance Status (ECOG-PS) score 2-4 points ( P =0.043) , IPI score 3-5 points ( P =0.001) , β(2)-MG elevation (≥5.5 mg/L) ( P =0.007) , and systemic chemotherapy cycles less than four times ( P <0.001) were the negative prognostic factors affecting the OS of patients. The Cox multivariate analysis depicted that age ≥60 years ( HR =2.272, 95% CI 1.110-4.651, P =0.025) , IPI score 3-5 points ( HR =3.562, 95% CI 1.794-7.074, P <0.001) , ECOG-PS score 2-4 points ( HR =2.675, 95% CI 1.162-6.153, P =0.021) , and number of cycles of chemotherapy<4 ( HR =0.290, 95% CI 0.176-0.479, P <0.001) were independent risk factors for adverse prognosis of OS. Conclusion: HIV-associated DLBCL is the most common HIV-related tumor, is most commonly seen in men, and has a high 1-year mortality rate. Chemotherapy combined with antiretroviral therapy can improve patient prognosis.

Real-world data study evidence, as an important part of evaluating the safety and effectiveness of drugs and devices, has attracted increasing attention from regulatory agencies and scholars both at home and abroad, and has become an essential source of evidence to support the development and review of drugs and devices. This paper systematically discusses the process and mode of real-world data system construction based on the preliminary practical study of real-world data according to the guidelines/technical specifications issued by regulatory agencies and academic research results. This study result provides not only reference for the generation of clinical evaluation evidence to meet the regulatory requirements for innovative drugs and devices, but also reference for researchers, sponsors and regulators to carry out real-world data studies successfully.

OBJECTIVE: To investigate the combination of traditional Chinese and western medicine in the treatment of cardiovascular diseases based on the real medical data in primary hospitals, so as to provide references for rational application of Chinese and western medicine in primary hospitals. METHODS: Totally 90 064 outpatient prescriptions in the hospital information system from 12 primary hospitals from 2019 to 2020 in Yanqing District, Beijing were selected, information related to patients with cardiovascular diseases in 33 234 prescriptions for cardiovascular disease and 9 649 prescriptions for combination application of Chinese and western medicine were extracted. Descriptive statistical analysis was performed on general information and disease conditions of patients with cardiovascular diseases, frequency analysis was used to explore the combined application of Chinese and western medicine in patients with cardiovascular diseases, and Apriori association rule algorithm was adopted to analyze the pattern of combined application of traditional Chinese and western medicine in primary hospitals. RESULTS: From 2019 to 2020, outpatient prescnptlons for cardiovascular diseases accounted for 36. 90% of the total outpatient prescriptions in 12 primary community hospitals in Y anqing District, Beijing. Among the 33 234 outpatient prescriptions for cardiovascular disease, prescriptions for combined application of traditional Chinese and western medicine accounted for 29. 03% ; prescriptions for patients >45 years accounted for 96. 56% ( 9 317 prescriptions) ; prescriptions for female patients ( 4 956 prescriptions, 51. 36%) was more than male patients ( 4 693 prescriptions, 48. 64%) ; prescriptions for patients with hypertension, coronary heart disease and hypercholesterolemia accounted for 71. 59% ( 6 908 prescriptions), of which the prescription for hypertension was the most, totally 3 874 prescriptions, accounting for 40. 15%. Among the prescriptions for combined application of traditional Chinese and western medicine, the number of categories of traditional Chinese and western medicine were respectively 312 and 223, the categories of traditional Chinese medicine with high use rate included traditional Chinese topical ointment, Ganmao Qingre granules, Fufang Danshen preparation ( tablets and dropping pill), Huoxiang Zhengqi preparation ( oral liquid and soft capsule) and Niuhuang Qingxin pill, and that of western medicine included aspirin, amlodipine, nifedipine and atorvastatin; the categories of combined application of traditional Chinese and western medicine mainly involved combination among anti-hypertensive drugs, antiplatelet drugs, lipid-regulating drugs and blood-regulating recipe, tonic prescription and diaphoretic recipes; results of the association analysis showed that among the drugs with high confidence in the combined application of traditional Chinese and western medicine, western medicine were relatively unchanged, including aspirin, nifedipine and amlodipine, while there were more categories of traditional Chinese medicine, including Xuesaitong preparation ( tablets, soft capsules, capsules and injections), Maixuekang capsule, N aoxintong capsule, Tongxinluo capsule, Shexiang Baoxin pills and Yinxing preparation ( drop pills, tablets, capsules and injections) ; in terms of combined application of western medicine, the confidence coefficient of statins and aspirin was higher; in terms of the combined application of traditional Chinese medicine, the confidence coefficient of Jinkui Shenqi pill and Wuling capsule, Xuesaitong preparation (tablets, soft capsules, capsules and injections) and Fufang Danshen preparation ( tablets and dropping pill), Biqi capsules and Dahuoluo preparation ( pills and capsules ) were higher. CONCLUSIONS: In the real world, primary hospitals have the phenomenon of more patients with cardiovascular diseases, more prescriptions for combined application of traditional Chinese and western medicine and more varieties of combined application of traditional Chinese and western medicine, the combined application of traditional Chinese and western medicine is quite common, so that primary clinicians should pay attention to the benefits and risks. [ABSTRACT FROM AUTHOR]

Objective To explore whether early treatment with integrated Chinese and western medicine can prolong the survival time of patients with advanced digestive tract malignant tumors using a new statistical analysis method and real-world data. Methods Based on the left truncated data, the Copula model was used to construct a joint model of the time from stage IV diagnosis to treatment and the time to overall survival. The estimated value and significance of the Copula dependence parameter, η, were obtained to evaluate the dependence strength between the two event times of interest. Results The numerical simulation showed that this method performed well when the left truncation rate was 20%. The estimated Copula dependence parameter η), in the real data analysis was 0.279 (P<0.05), indicating that there was a significant correlation between times to treatment and overall survival. Gender, the Eastern Cooperative Oncology Group score, targeted treatment, and metastatic site 1 were significant factors associated with overall survival. Conclusion The new statistical method provided valuable insights and analytical tools for the effectiveness of integrated traditional Chinese and western medicine in treating patients with advanced digestive tract malignant tumors. [ABSTRACT FROM AUTHOR]

Objective·To investigate the clinical characteristics of ischemic cardiovascular and cerebrovascular co-morbidities and the actual factors influencing the extension of hospitalization days. Methods·Patients with first diagnosis of coronary artery heart disease (CHD) or cerebrovascular disease in the First Affiliated Hospital of Xinjiang Medical University from December 2009 to June 2020 were selected as participants by retrieving electronic medical record (EMR) and divided into CHD group, cerebrovascular disease group, and cardiovascular and cerebrovascular co-morbidities group. Retrospective analysis was performed to compare the characteristics, hospitalization days and costs of each group, and compare the correlation between different costs and total hospitalization costs in each group. Logistic regression analysis was used to explore the influencing factors associated with hospitalization days extension. Results·A total of 22 216 patients were selected. Compared with single-disease groups, the patients in the comorbid group were older [(67±9) years] and had a higher prevalence of hypertension and atrial fibrillation, 75.4% and 9.0%, respectively; low-density lipoprotein cholesterol (LDL-Ch), leukocyte, and hemoglobin (Hb) levels were the highest (all P< 0.05). CHD group had a higher proportion of males (65.8%, P=0.000), 37.2% and 23.5% of patients with smoking and drinking habits, and high prevalence of diabetes and dyslipidemia, 43.8% and 64.0%, respectively (all P<0.05). In terms of hospitalization costs, the total hospital costs had a stronger correlation with consumables costs in the cardiovascular and cerebrovascular comorbidity group (P=0.000). The occurrence of co-morbidities led to increased costs for supplies and out-of-pocket expenses. Multifactorial Logistic regression analysis showed that gender (OR=1.158,95%CI 1.004‒1.336, P=0.045), age (OR=1.317,95%CI 1.112 ‒ 1.559, P=0.000) and prevalence of dyslipidemia (OR=1.361, 95%CI 1.167 ‒ 1.586, P=0.000) all correlated with longer hospitalization days (all P<0.05). Elevated blood pressure, higher low-density lipoprotein, and atrial fibrillation prevalence increased the number of hospital days in the cardiovascular and cerebrovascular co-morbidities group. Conclusion·Patients with cardiovascular and cerebrovascular co-morbidities are characterized by older age, high prevalence of hypertension and atrial fibrillation, as well as higher LDL-Ch, WBC, and Hb levels. The male age, and prevalence of dyslipidemia are the main risk factors that mainly influence the extension of hospitalization days in patients with cardiovascular and cerebrovascular co-morbidities. [ABSTRACT FROM AUTHOR]

Objective: To study the real-world outcome of China FDA-approved Sofosbuvir (SOF)/Velpatasvir (VEL) in Northwest China. Methods: In this multicenter, prospective, real-world cohort study, we recruited patients from 10 sites from Northwest China, who were chronically infected with HCV GTs 1-6 from 06/2018 to 09/2019. Patients received SOF (400mg)/VEL (100mg) for 12 weeks, and with ribavirin 900-1200 mg for GT3 cirrhosis and for any genotype decompensated cirrhosis. The primary endpoint was sustained virological response at 12-weeks post-treatment (SVR12) and safety. The secondary endpoint was the change of liver function after the achievement of SVR12. Results: Totally, 143 patients were enrolled in the study, four patients were lost to follow-up and one died during the follow-up, 138 patients were included in per-protocol analysis. Of the 138 patients, the mean age 53 years, 53.6% male, 94.2% Han nationality, 53.6% liver cirrhosis, 10.1% HBsAg(+), 6.5% renal dysfunction, 5.1% treatment-experienced, and 16.7% patients received ribavirin treatment. The genotype distribution was as follows: 35.5% GT1, 42.8% GT2, 15.9% GT3, and 5.8% un-typed. The SVR12 rate was 96.5% (138/143, 95% CI : 93.5%-99.6%) for intention-to-treat analysis, and in per-protocol analysis, all 138 patients obtained SVR12 (100%). Compared with baseline, the serum total bilirubin, ALT and AFP levels decreased (all P < 0.05), as well as increased ALB and platelet count (all P < 0.001) at post-treatment 12-weeks. Overall adverse events (AEs) rate is 29.0%, and the most common AEs were anemia (14.5%) and fatigue (8.0%). Severe side effects (edema and fatigue) occurred in 2 patients, one of whom needed a short-term interruption of treatment due to fatigue. Conclusion: In this real-world cohort study, 12-week SOF/VEL regimen with or without ribavirin achieved high SVR12 rates (96.5%-100% overall) with excellent safety profile among patients with HCV GT1/2/3 infection including patients with GT3 and cirrhosis, and led to improvement of liver function.

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.

Neonatal seizures are the most common clinical manifestations of critically ill neonates and often suggest serious diseases and complicated etiologies. The precise diagnosis of this disease can optimize the use of anti-seizure medication, reduce hospital costs, and improve the long-term neurodevelopmental outcomes. Currently, a few artificial intelligence-assisted diagnosis and treatment systems have been developed for neonatal seizures, but there is still a lack of high-level evidence for the diagnosis and treatment value in the real world. Based on an artificial intelligence-assisted diagnosis and treatment systems that has been developed for neonatal seizures, this study plans to recruit 370 neonates at a high risk of seizures from 6 neonatal intensive care units (NICUs) in China, in order to evaluate the effect of the system on the diagnosis, treatment, and prognosis of neonatal seizures in neonates with different gestational ages in the NICU. In this study, a diagnostic study protocol is used to evaluate the diagnostic value of the system, and a randomized parallel-controlled trial is designed to evaluate the effect of the system on the treatment and prognosis of neonates at a high risk of seizures. This multicenter prospective study will provide high-level evidence for the clinical application of artificial intelligence-assisted diagnosis and treatment systems for neonatal seizures in the real world.

Estimating the actual real-world effectiveness of the vaccine is an essential part of the post-marketing evaluation. This regression discontinuity design (RDD) using observational data is designed to quantify the effect of an intervention when eligibility for the intervention is based on a defined cutoff as age, making it suited to estimate vaccine effects. This approach can avoid the high cost and ethical issues; overcome difficulties in the organization and practice process in randomized controlled trials, which leads to a higher level of causal inference evidence and more realistic results. Here, we describe key features of RDD in general, and then specific scenarios, with examples, to illustrate that RDD are an essential tool for advancing our understanding of vaccine effects.

Objective: To evaluate the incidence of immune checkpoint inhibitor-based combination therapy-induced liver damage in patients with primary liver cancer. Methods: Clinical data of 65 hospitalized cases of primary liver cancer treated with programmed cell death-1 its ligand programmed death-ligand 1 (PD-1/PD-L1) antibody in the Department of Infectious Diseases of the Second Affiliated Hospital of Chongqing Medical University from January 1, 2018 to March 31, 2021 were retrospectively analyzed. The degree of liver injury before and after treatment was assessed according to CTCAE v5.0. Patients were grouped according to gender, age, presence or absence of cirrhosis, baseline Child-Pugh score, BCLC stage, and treatment regimen to compare the incidence of liver injury under different conditions. The χ (2) test or rank-sum test was used for comparison among multiple groups. Results: 46 cases (70.77%) had liver damage of any grade according to the CTCAE V5.0 criteria during the treatment and observation period. All 6 cases who received standardized anti-hepatitis B virus (HBV) treatment developed liver damage. 10 (15.38%), 15 (23.08%), 19 (29.23%), and 2 (3.08%) cases had grade 1, 2, 3, and 4 liver damage respectively. There was no statistically significant difference in the incidence of liver damage between male and female patients (68.33% and 100%, P = 0.180). There was no statistically significant difference in the incidence of liver damage among different age groups ( P = 0.245). The incidence of liver damage in cirrhotic and non-cirrhotic group was 72.22%, and 63.64% ( P = 0.370), respectively. The incidence of liver damage in patients with baseline Child-Pugh class A, B, and C were 71.43%, 61.11% and 100%, respectively, and the difference was not statistically significant ( P = 0.878). The incidence of liver damage was not statistically significantly different under different BCLC stages ( P = 1.000). The incidence of liver damage in the PD-1/PD-L1 antibody monotherapy, PD-1/PD-L1 antibody combined with targeted drug therapy, and PD-1/PD-L1 antibody combined with TACE/radiofrequency ablation treatment group were 60.00%, 67.85%, and 86.67%, respectively. There was no statistically significant difference in the incidence of liver damage between the treatment regimen ( P = 0.480). Conclusion: Immune checkpoint inhibitor therapy-induced liver damage is common in patients with primary liver cancer; however, it rarely severely endangers the patient's life. Additionally, patient's gender, age, presence or absence of cirrhosis, baseline liver function, BCLC stage and the immunotherapy regimen has no effect on the incidence of immune-related liver damage.

To investigate the relationship between serum C-reactive protein (CRP) levels and work impairment in patients with ankylosing spondylitis (AS) based on real-world evidence. Outpatients with confirmed AS at Chinese PLA General Hospital were recruited consecutively by Smart-phone SpondyloArthritis Management System (SpAMS) from April 2016 to April 2018. The relationship between CRP and work productivity and activity impairment questionnaire (WPAI) were evaluated. Five hundred and fifty-one outpatients with AS in paid employment were recruited. The presenteeism, overall work impairment, and activity impairment rates increased by 1.4% (1.1%, 1.8%), 1.1% (0.5%, 1.6%), and 1.7% (1.3%, 2.1%), respectively, for every 10 mg/L increase in the CRP level (all P value<0.01). However, the CRP level was not associated with absenteeism after adjusting for covariates [0.5%(-0.4%, 1.0%), P >0.05]. There is a significant association between increased serum CRP levels at baseline and the previous 7-day work impairment in patients with AS. Higher CRP levels contribute to worse presenteeism, overall work impairment, and activity impairment rates, which suggests the necessity of monitoring CRP on treatment, and also indicates that anti-inflammatory therapy may be effective for improving work productivity.

Objective To observe the effect of oral Objective To statistically analyze the effects of oral non-thiazide diuretics on glucose and lipid metabolism in patients with heart failure under real-world scenarios. Method Use the hospital network The Information System (HIS) system retrospectively screens eligible patients with heart failure who have been hospitalized in the Department of Cardiology or Cardiothoracic Surgery of the hospital from January 2018 to June 2020. Pick Collect the blood glucose and blood lipid indexes of all patients on the second admission and conduct a comparative analysis. At the same time, statistics were made on whether all patients finally used hypoglycemic drugs and lipid-lowering drugs. Results A total of 94 patients with heart failure were enrolled. All patients had 2 admissions for glycosylated hemoglobin (HbA1c) and fasting blood glucose (FPG). The latter included triacylglycerol (TG), total Cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) levels did not change significantly (P>0.05). Among 94 patients, Four cases eventually used lipid-lowering drugs, and the other two received oral hypoglycemic drugs. Conclusion In a real environment, oral non-thiazide diuretics will not significantly affect heart failure. The levels of HbA1c, FPG, TG, TC, HDL-C, and LDL-C in hospitalized patients, but such patients belong to high-risk groups of atherosclerosis and diabetes. Sugar drugs and lipid-lowering drugs. [ABSTRACT FROM AUTHOR]

Real world data (RWD) refers to the data generated in routine clinical practices, daily life, and real work environment and has been widely used in clinical or public health research. Still, issues related to the quality of RWD, such as incompleteness, inconsistency, and inaccuracy, would affect the validity of real-world research. To overcome the challenges due to the lack of standardization of real world source data, case report form based on clinical data interchange standards consortium (CDISC-CRF) on certain diseases was developed to promote the ecology construction of RWD based on the data standards set by the CDISC which has been widely used. Firstly, we described how to apply data standards to make up the gap between RWD and real world evidence. Then, the process was designed to build RWD ecology based on CDISC-CRF, in which the development technology of CDISC-CRF form is mainly introduced. Finally, the application prospect and significance of building real-world data based on disease-specific CDISC-CRF are described. It is believed that the present paper can provide a new idea for promoting the ecology construction of RWD in China.

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Objective: To observe the clinical therapeutic effect on mild and moderate postpartum depression treated with acupuncture of Tiaoren Tongdu (regulating the conception vessel and unblocking the governor vessel) on the base of real world., Methods: A total of 116 patients with mild and moderate postpartum depression were divided into an acupuncture group (103 cases) and a non-acupuncture group (13 cases) according to treatment regimen provided. In the acupuncture group, acupuncture of Tiaoren Tongdu was applied to Baihui (GV 20), Yintang (GV 29), Zhongwan (CV 12), Qihai (CV 6), Guanyuan (CV 4), Neiguan (PC 6), Shenmen (HT 7), Hegu (LI 4), Zusanli (ST 36), Sanyinjiao (SP 6) and Taichong (LR 3). Needles were retained for 30 min each time, the treatment was given once every other day, 3 times a week. In the non-acupuncture group, psychotherapy was provided, once daily. The duration of treatment in the two groups was 8 weeks. According to the treatment times of acupuncture, the acupuncture group was subdivided into an acupuncture A group (60 cases with total treatments ≥ 6 times) and an acupuncture B group (43 cases with total treatments<6 times). Using propensity score matching method, the patients of the acupuncture A and B groups were matched each other. Finally, 31 pairs of cases were matched successfully. Before treatment, at 1st, 2nd, 4th and 8th weeks of treatment, as well as at 3-month follow-up, the scores of Hamilton depression scale (HAMD) were compared in patients among the three groups. Using Logistic regression, the impact of acupuncture frequencies on the therapeutic effect was analyzed and the clinical therapeutic effect was assessed., Results: The total effective rate of the acupuncture A group was 100.0% (31/31), better than 76.9% (10/13) in the non-acupuncture group and 58.1% in the acupuncture B group (18/31) ( P <0.05). HAMD score at each time point after treatment was lower than that before treatment in the patients of each group ( P <0.05). But HAMD score at each time point after treatment in either the acupuncture A group or the acupuncture B group was lower than that in the non-acupuncture group separately ( P <0.05), HAMD scores in the acupuncture A group at the 4th and 8th weeks of treatment and at follow-up were lower than those in the acupuncture B group ( P <0.05). Logistic regression analysis showed that the total times of acupuncture treatment and the persistent days of treatment had a certain relation to therapeutic effect ( P <0.05)., Conclusion: Acupuncture of Tiaoren Tongdu effectively improves in mild and moderate postpartum depression and its therapeutic effect is closely related to treatment course.

Objectives: As the main implant material, coronary stent is one of the main factors that affect clinical treatment outcome and patient cost. The choice for coronary stent in clinic depends on multiply factors including patient preference, medical personnel expertise and current technology, and no recognized method has been established for the evaluation and choice of coronary stent. In this study, we aim to evaluate the safety, effectiveness, and economy of a few drug-eluting coronary stents in clinic., Methods: A retrospective analysis was employed to study the cases treated by drug-eluting stent intervention in a third grade hospital from January 2018 to December 2019. Based on the specific products, these cases were assigned into a domestic stent A group, a domestic stent B group, a domestic stent C group, and an imported stent group. According to the severity of the disease, they were divided into an angina pectoris, an acute myocardial infarction, and an ischemic heart disease subgroups. Layer analysis was carried out for inter-subgroup comparisons in terms of safety (indicated by mortality rate, complication rate, and infection rate), efficacy (indicated by 31-day return rate, 365-day myocardial infarction rate, restenosis rate, secondary intervention rate, and thrombosis rate), and economy (indicated by averaged total cost and coronary stent cost)., Results: Among the 4 products, there was no difference in safety ( P >0.05). Except for patients with acute myocardial infarction, there was no significant difference in the effectiveness of the 4 products for the other 2 diseases. The economical aspect of the domestic stent B and the domestic stent C was better than that of the domestic stent A and the imported stent (all P <0.05)., Conclusions: With all the indicators of these 4 stents taken into consideration, we conclude that hospitals may appropriately increase the share of domestic coronary stent in product selection and in-hospital management. This measure helps increase product localization rate and ease the financial burden for patients by reducing coronary stent cost.

Objective To demonstrate the clinical efficiency mid safoty of palhocidib combined With endocrine therapy in the treatment of hormone receptor ( HR ) positive and human epidermal growth factor receptor 2 ( HER-2) negative advmiced hreast cancer patients. Methods A total of 95 breast cancer patients with HR-positive/HER-2 negative underwent palhocidih combined with emlocrine in .Timigsu Cancer Hospital from Octorher, 2018 to Novermher, 2020 were retrospectively recruited. The shmi-term and longterm efficacy mid adverse reactions were summurized The primary end point was progressive free survival ( P FS) and the second end points were disease control rate ( DCR), objective response rate ( 0 RR ), clinical benefit rate ( CBR). Log rmik test and Cox proporional hazards regression model were used to mialyze the influencing factors of PFS in patients. Results The ORR, DCR and CBR of 95 patients were 29.5%·, 88.4%· and 72.6%·, respectively. The total median PFS for palhocidih plus endocrine therapy was10.4 months. The univariate analysis showcxl that visceral metastasis, the line number of palbocidib treatment and the sensitivity of emlocrine therapy were associated with the PFS of patients who received palbocidib combined with endocrine ( P < 0. 05) . The multivriate Cox regression analysis showed that the sensitivity of endocrine therapy and viscer;J mc:tastasis were the independent influencing factors of PFS in patients receiving p;Jbocidib combined with endocrine therapy. Complexl with patients with visceral metastasis, HR of patients with non-viscenJ metastases was 3.118 ( 95%· CI: 1.405-7 .236) . Compared with endocrine therapy sensitive patients, the HR of patients with primary and secondary resistmwe to emlocrine therapy were 4.455 ( 95%· CI: 1.380-14.385) and 1 .4566 ( 95%· CI: 0.488-4.346), respectively. The main adverse: reaction was hc:heatological toxicity. The leukopenia, neutrnphilsand thrnmboqiopenia were: main manifestations, which incidence rates were: 78. 9%· ( 75/95), 85. 3%• ( 81/95) and 72. 6%• ( 69/95), respectively and the incidence: rates of grade 3 to 4 of these manikstations were: 27.4%· ( 26/95), 51.6%• ( 49/95) and 20. Wk ( 19/95), respectively. Conclusion Among patients with HR-positivc/HER-2 negative advanced breast cmicer, the treatment of palbocidib combined with endocrine: drugs has yielded good clinical effects and the toxicity is manageable. [ABSTRACT FROM AUTHOR]

Objective To observe the efficacy of first line regimen containing nivolumab in the treatment of meningeal carcinomatosis（MC）. Methods Four patients diagnosed by cerebrospinal fluid （CSF）cytology in the Department of Oncology, Huashan Hospital, Fudan University from Apr 1 to Oct 1 2019 were enrolled. They all received nivolumab combined regimen in the first line. The clinical characteristics of CSF tumor burden（TB）, meningeal enhancement, hydrocephalus, and central nervous system （CNS） symptoms were summarized, and their relevance with short-term and long-term efficacy was analyzed. Results The primary tumor included two cases of lung cancer treated by multi-line targeted treatment, one case of cholangiocarcinoma, and one case of unknown primary tumor. Two patients had low CSF TB. The other two patients with high CSF TB complicated with hydrocephalus were treated with CSF shunt first. The median course of treatment with nivolumab combined with chemotherapy and/or antiangiogenic drugs was 5.5（5-33）. Until the final follow-up on May 1, 2022, the median follow-up was 610（153-947）days, one patient had no progression, two were still alive, all patients had no CNS side effect. The CNS symptoms of all patients were relieved on the first assessment after treatment, and the median follow-up was 46（37-65）days. Three patients had decreased CSF TB, and their CNS progression free survival（PFS）were 108, 134 and >944 days, respectively. One patient had no change in CSF TB, and his PFS was only 76 days. Patients with low CSF TB had longer overall survival（OS）than those with high CSF TB（>947 days and >944 days vs. 153 days and 275 days）. Conclusion In the first line treatment of MC patients with nivolumab, the decrease of CSF TB in the short term may indicate a longer CNS PFS, and the low CSF TB may indicate a longer OS. The efficacy is worthy of further verification. [ABSTRACT FROM AUTHOR]

Objective: To observe the efficacy and safety of albumin-bound paclitaxel in the treatment of metastatic breast cancer. Methods: Multi-center data of patients who accepted single-drug albumin-bound paclitaxel or combination regimens from 2013 to 2019 were collected and the efficacy and safety were evaluated. Kaplan-Meier method was used for survival analysis, while Log-rank test was used to compare the survival rates. Results: A total of 203 advanced breast cancer cases were enrolled. The median progression-free survival time (PFS) lasted for 4 months, the median overall survival(OS)was 14 months, objective response rate (ORR) was 36.0% while the disease control rate (DCR) was 81.3%. The ORRs of Luminal, human epidermal growth factor receptor 2 (HER2) overexpression and triple-negative breast cancer patients underwent albumin-bound paclitaxel treatment were 37.3%, 45.5% and 31.0%, respectively, the DCRs were 85.5%, 68.2% and 78.9%, respectively. The OS of patients with relapse or metastasis who accepted less than two and more than two chemotherapy regimens were 22 months and 11 months ( P <0.000 1), the ORRs were 44.9% vs 30.4%, DCRs were 87.2% vs 77.6% ( P =0.018). The ORR and DCR of patients who accepted traditional paclitaxel treatment before the albumin-bound paclitaxel treatment were 35.8% and 82.1%, respectively. The common adverse reaction of these patients was numbness of limbs, which incidence rate was 64.5% (131/203), and 61.1% (124/203) were degree 1 to 2. Other adverse reactions including decreased white blood cells, which incidence rate was 56.1% (114/203); nausea and vomit, which incidence rate was 36.9% (75/203); anemia, which incidence rate was 21.2% (43/203); decreased platelet, which incidence rate was 18.7% (38/203); hepatic dysfunction, which incidence rate was 18.2% (37/203). Conclusions: Albumin-bound paclitaxel single or combination regimen is still significant efficient for various molecular subtypes of breast cancer patients or patients with traditional paclitaxel resistance or multi-line chemotherapy failure. Early usage has better prognosis, controllable adverse reaction and prominent clinical application value.

Objectives: To study the efficacy of Huaiqihuang granules as adjuvant therapy for bronchial asthma in children., Methods: A multicenter, prospective, and registered real-world study was performed for the children, aged 2-5 years, who had a confirmed diagnosis of bronchial asthma in the outpatient service of 21 hospitals in China. Among these children, the children treated with medications for long-term asthma control (inhaled corticosteroid and/or leukotriene receptor antagonist) without Huaiqihuang granules were enrolled as the control treatment group, and those treated with medications for long-term asthma control combined with Huaiqihuang granules were enrolled as the combined treatment group. The medical data of all children were collected. Outpatient or telephone follow-up was performed at weeks 4, 8, 12, 20, 28, and 36 after treatment, including asthma attacks and rhinitis symptoms. A statistical analysis was performed for the changes in these indices., Results: There was no significant difference in the frequency of asthma attacks or rhinitis attacks between the two groups before treatment ( P >0.05). After treatment, the combined treatment group had significantly lower frequencies of asthma attacks, severe asthma attacks, and rhinitis attacks compared with the control treatment group ( P <0.05). There was no signification difference in the incidence rate of adverse reactions between the two groups ( P =0.667)., Conclusions: Huaiqihuang granules in addition to medications for long-term asthma control can alleviate the symptoms of bronchial asthma and rhinitis and improve the level of asthma control in children with bronchial asthma, with good safety and little adverse effect. Citation .

Objective: To explore the effect of perioperative chemotherapy on the prognosis of gastric cancer patients under real-world condition. Methods: A retrospective cohort study was carried out. Real world data of gastric cancer patients receiving perioperative chemotherapy and surgery + adjuvant chemotherapy in 33 domestic hospitals from January 1, 2014 to January 31, 2016 were collected. Inclusion criteria: (1) gastric adenocarcinoma was confirmed by histopathology, and clinical stage was cT2-4aN0-3M0 (AJCC 8th edition); (2) D2 radical gastric cancer surgery was performed; (3) at least one cycle of neoadjuvant chemotherapy (NAC) was completed; (4) at least 4 cycles of adjuvant chemotherapy (AC) [SOX (S-1+oxaliplatin) or CapeOX (capecitabine + oxaliplatin)] were completed. Exclusion criteria: (1) complicated with other malignant tumors; (2) radiotherapy received; (3) patients with incomplete data. The enrolled patients who received neoadjuvant chemotherapy and adjuvant chemotherapy were included in the perioperative chemotherapy group, and those who received only postoperative adjuvant chemotherapy were included in the surgery + adjuvant chemotherapy group. Propensity score matching (PSM) method was used to control selection bias. The primary outcome were overall survival (OS) and progression-free survival (PFS) after PSM. OS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the last effective follow-up or death. PFS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the first imaging diagnosis of tumor progression or death. The Kaplan-Meier method was used to estimate the survival rate, and the Cox proportional hazards model was used to evaluate the independent effect of perioperative chemo therapy on OS and PFS. Results: 2 045 cases were included, including 1 293 cases in the surgery+adjuvant chemotherapy group and 752 cases in the perioperative chemotherapy group. After PSM, 492 pairs were included in the analysis. There were no statistically significant differences in gender, age, body mass index, tumor stage before treatment, and tumor location between the two groups (all P >0.05). Compared with the surgery + adjuvant chemotherapy group, patients in the perioperative chemotherapy group had higher proportion of total gastrectomy (χ(2)=40.526, P <0.001), smaller maximum tumor diameter ( t =3.969, P <0.001), less number of metastatic lymph nodes ( t =1.343, P <0.001), lower ratio of vessel invasion (χ(2)=11.897, P =0.001) and nerve invasion (χ(2)=12.338, P <0.001). In the perioperative chemotherapy group and surgery + adjuvant chemotherapy group, 24 cases (4.9%) and 17 cases (3.4%) developed postoperative complications, respectively, and no significant difference was found between two groups (χ(2)=0.815, P =0.367). The median OS of the perioperative chemotherapy group was longer than that of the surgery + adjuvant chemotherapy group (65 months vs. 45 months, HR: 0.74, 95% CI: 0.62-0.89, P =0.001); the median PFS of the perioperative chemotherapy group was also longer than that of the surgery+adjuvant chemotherapy group (56 months vs. 36 months, HR=0.72, 95% CI:0.61-0.85, P <0.001). The forest plot results of subgroup analysis showed that both men and women could benefit from perioperative chemotherapy (all P <0.05); patients over 45 years of age ( P <0.05) and with normal body mass ( P <0.01) could benefit significantly; patients with cTNM stage II and III presented a trend of benefit or could benefit significantly ( P <0.05); patients with signet ring cell carcinoma benefited little ( P >0.05); tumors in the gastric body and gastric antrum benefited more significantly ( P <0.05). Conclusion: Perioperative chemotherapy can improve the prognosis of gastric cancer patients.

To explore the focus and trends in real-world studies in Chinese through knowledge mapping method, databases CNKI, VIP, Wanfang and Sinomed were retrieved, with 1 757 relevant articles published before September 30rd, 2020 finally included, whose bibliographical records were imported into NoteExpress to avoid duplication and check relativity. VOSviewer, a bibliometric analysis tool, was used to analyze their development. It was found that real-world studies have mainly taken shape after 2010, in which traditional Chinese medicine research plays an important role. China Journal of Chinese Material Medica was the leading journal with 120 papers, the China Academy of Chinese Medical Sciences the most contribution institution with 338 papers, and Xie Yanming from the institution the most contribution author with 250 papers. This study helps clinicians and researchers in better understanding the evolution of real-world research over more than two decades in China.

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Objective The aim of this study was to investigate the correlations between body composition and traditional Chinese medicine (TCM) constitution in normal-weight, overweight, and obese outpatients in Department of Acupuncture for Endocrine-related Obesity. Methods The "YiJianZhong Weight Management" We Chat app was used to record patients' weight, TCM constitution (only five types of TCM constitutions were included: balanced constitution, phlegm-dampness constitution, damp-heat constitution, yang-deficiency constitution, and qi-stagnation constitution), and other information. In addition, a body composition analyzer was used to collect the information including the percentage of body fat, body mass index (BMI), basal metabolic rate, and visceral fat index. Finally, the body constitution data of patients with different TCM constitutions were summarized and analyzed. Results A total of 308 patients were included in the analysis, including 100 cases of normal-weight patients and 208 cases of obese or overweight patients. The proportions of TCM constitutions in the normal-weight patients were ranked from most to least as follows; balanced constitution > yang-deficiency constitution > damp-heat constitution > qi-stagnation constitution > phlegm-dampness constitution, while the proportions of TCM constitutions in obese and overweight patients were ranked in the same order as follows; balanced constitution > phlegm-dampness constitution > damp-heat constitution > yang-deficiency constitution > qi-stagnation constitution. There was no significant difference in the composition ratio of the different TCM constitutions between normal-weight patients and overweight, obese patients. The BMIs of all the patients were negatively correlated with the qi-stagnation constitution scores. The BMI decreased by 0.152 kg/m when the qi-stagnation constitution score increased by one point. The age and qi-stagnation constitution scores had a positive interaction with the BMI. For every 1-year increase in the average age of patients, the effect of the qi-stagnation constitution scores on the BMI changed from -0.152 kg/m to -0.147 kg/m. Conclusion In terms of the TCM constitution, a balanced constitution accounted for the highest proportion in normal-weight patients, overweight, and obese patients, while phlegm-dampness and damp-heat constitution accounted for a higher proportion in overweight and obese patients, except for the balanced constitution. In addition, in terms of the relationship between the TCM constitution and body composition, due to the negative correlation between the BMI and the qi-stagnation constitution score, overweight or obese patients with a qi-stagnation constitution should pay more attention to the influence of body composition indicators other than BMI on the development of disease. [ABSTRACT FROM AUTHOR]

Objective: To describe the actual efficacy of programmed death-1 (PD-1)/ programmed-death ligand 1 (PD-L1) inhibitors in patients with metastatic non-small cell lung cancer (NSCLC) and explore potential prognostic predictive biomarkers. Methods: Patients with metastatic NSCLC who were treated with PD-1/PD-L1 inhibitors at Cancer Hospital, Chinese Academy of Medical Sciences from January 2016 to December 2019, either as monotherapy or in combination with other agents, were consecutively enrolled into this study. We retrospectively collected the data of demographics, clinical information and pathologic assessment to evaluate the therapeutic efficacy and conduct the survival analysis. Major endpoint of our study is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR) and overall survival (OS). Results: The ORR of 174 patients who underwent PD-1/PD-L1 inhibitor was 28.7%, and the DCR was 79.3%. Immune-related adverse events (irAEs) occurred in 23 patients (13.2%). Brain metastasis, line of treatment, and treatment patterns were associated with the ORR of metastatic NSCLC patients who underwent immunotherapy (P<0.05). After a median follow-up duration of 18.8 months, the median PFS was 10.5 months (ranged from 1.5 to 40.8 months) while the median OS was not reached. The 2-year survival rate was estimated to be 63.0%. The pathologic type was related with the PFS of metastatic NSCLC patients who underwent immunotherapy (P=0.028). Sex, age, brain metastasis and autoimmune diseases were associated with OS (P<0.05). Analysis of the receptor characteristic curve (ROC) of neutrophil/lymphocyte ratio (NLR) predicting ORR of immunotherapy in metastatic NSCLC showed that the areas under the curve of NLR before immunotherapy (NLR(C0)), NLR after one cycle of immunotherapy (NLR(C1)) and ΔNLR were 0.600, 0.706 and 0.628, respectively. Multivariate logistic regression analysis showed that NLR(C1) was an independent factor of the ORR of metastatic NSCLC patients who underwent immunotherapy (OR=0.161, 95% CI: 0.062-0.422), and the efficacy of combination therapy was better than that of single agent (OR=0.395, 95% CI: 0.174-0.896). The immunotherapy efficacy in patients without brain metastasis was better than those with metastasis (OR=0.291, 95% CI: 0.095-0.887). Multivariate Cox regression analysis showed that NLR(C1) was an independent influencing factor of PFS of metastatic NSCLC patients after immunotherapy (HR=0.480, 95% CI: 0.303-0.759). Sex (HR=0.399, 95% CI: 0.161-0.991, P=0.048), age (HR=0.356, 95% CI: 0.170-0.745, P=0.006) were independent influencing factors of OS of metastatic NSCLC patients after immunotherapy. Conclusions: PD-1/PD-L1 inhibitors are proved to be efficacious and have tolerable toxicities for patients with metastatic NSCLC. Patients at advanced age could still benefit from immunotherapy. Brain metastasis is related to compromised response. Earlier application of immunotherapy in combination with other modalities enhances the efficacy without elevating risk of irAEs. NLR(C1) is an early predictor of clinical outcome. The OS of patients younger than 75 years may be improved when treated with immunotherapy. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety profile of ixazomib/lenalidomide/dexamethasone (IRd) in Chinese patients with relapsed/refractory multiple myeloma (MM) . Methods: This study comprising 14 medical centers in China included patients with relapsed/refractory MM who received at least. Ixazomib at an initial oral dose of 4 mg was administered. Seven patients had dose adjustment to 3 mg at the time of first dose. The lenalidomide doses were adjusted according to creatinine clearance rate. The efficacy and safety were evaluated every cycle. Results: In the study cohort of 74 patients, the median age was 65 years and 11 (14.9% ) patients received over three lines of therapy. Overall response rate (ORR) was 54.1% (40/74) , and 7 (9.5% ) , 14 (18.9% ) , and 19 (25.7% ) patients achieved stringent complete response or complete response, very good partial response, and partial response, respectively. The median progression-free survival and overall survival were 9.9 and 20 months, respectively. The median time to response was 1 month. The efficacy and survival outcome were similar to those reported in the Tourmaline-MM1 China Continuous Study. The ORR of patients refractory to bortezomib, lenalidomide, and bortezomib plus lenalidomide were 52.0% (13/25) , 57.1% (4/7) , and 33.3% (6/18) , respectively. The rate of grade 3-4 adverse events was 36.5% (27/74) . Common hematological toxicities were anemia, thrombocytopenia, lymphopenia, and neutropenia. Common non-hematological toxicities were fatigue, gastrointestinal symptoms, and infections. Two cases of grade 3 peripheral neuropathy were reported. The patients eligible for the Tourmaline-MM1 China Continuous Study had a higher ORR than the ineligible patients [77.8% (14/18) vs 46.4% (26/56) , P =0.020]. There was no difference in the rate of grade 3-4 adverse events [33.3% (6/18) vs 37.5% (21/56) , P =0.749]. Conclusion: The IRd regimen had good efficacy and acceptable toxicity in Chinese patients with relapsed/refractory MM.

Objective: To investigate the physical indices and growth status of preterm children aged 0 to 4 years with different birth weight. Methods: Following the real world research approach, the current study retrospectively collected e-chart information of 8 496 preterm children from the child health care system of the Children's Hospital of Chongqing Medical University from December 2010 to December 2017, with 203 123 full-term children followed up during the same period as controls. Premature children were divided into normal birth weight (NBW) group, low birth weight (LBW) group, and very low birth weight (VLBW) group based on their birth weights. The weight and length development within 48 months of age of preterm boys and girls in each group were measured and recorded to establish a numerical table and analyze the growth levels, growth rate, and proportionality. The t -test or chi-square test was used for between-group comparison. Results: Of the 8 496 preterm children, 4 839 were girls and 3 657 boys, including 525 in the VLBW group, with an average birth weight of (1.28±0.14) kg, 3 862 in the LBW group, with an average birth weight of (2.07±0.28) kg, and 4 109 in the NBW group, with an average birth weight of (2.86±0.35) kg. The weight at the actual age of 2-<3 months ((5.61±0.96) vs . (5.64±0.78) kg in boys, (5.11±0.67) vs . (5.18±0.71) kg in girls) and the length at the actual age of 8-<10 months ((70.3±2.4) vs . (70.6±2.4) cm in boys, (68.9±2.2) vs . (68.9±2.4) cm in girls) in the NBW group reached the average weight and length of full-term children. The difference of physical growth before 24 months of age between LBW and control group decreased as children age, with that of LBW group approaches the average of full-term children after 24 months of age, with a weight difference of 0.64-0.95 kg and height difference of 1.3-1.7 cm. The weight and height of the VLBW group were lower than those of full-term infants (2.80-2.86 kg and 3.3-4.3 cm, respectively) at 48 months of age. During 2-12 months of age, the corresponding values of the VLBW group were higher than that of the LBW and NBW groups by 0.35 kg and 0.71 kg, respectively. However, the corresponding values of the VLBW group were lower than that of the LBW and NBW groups(0.64 kg and 0.76 kg at 0-2 months of age, 1.04 kg and 1.49 kg at 12-48 months of age, respectively). The rates of delayed development, underweight, and emaciation were the highest in the VLBW group (all P <0.01), while the rates of overweight and obesity were the highest in the NBW group, with that of the VLBW group being lower than LBW group ( P <0.01) at the age of 24-<36 months. Conclusions: Prior to 4 years of age, the time for preterm children to reach the average physical indices of full-term children differ by birth weights, hence warranting further examination of the corrected gestational age for preterm children. Normal birth weight preterm children present with the highest incidence of overweight and obesity and very low birth weight preterm children present with the highest incidence of growth disorders, marking both groups at high risks of malnutrition.

Objective: To explore the real-world effectiveness and safety of sofosbuvir-based regimen for patients with chronic hepatitis C virus (HCV) genotype 6 infection in Hainan Island. Methods: Fifty-three cases with chronic hepatitis C virus (HCV) genotype 6 infection who were initially treated with a sofosbuvir (SOF)-based regimen [sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks or sofosbuvir combined with ribavirin (SOF+RBV) for 24 weeks], followed by 24 weeks of follow-up after discontinuation of the drug from January 2018 to March 2020 were selected. The primary outcome measures were incidence of sustained virological response at 12 weeks (SVR12) after the drug withdrawal. The secondary outcome measures were adverse drug events with sustained virological response at the end of treatment and 24 weeks after the end of treatment. The occurrence of adverse events was observed during the treatment. An intragroup comparison was performed by t-test. Intention-to-treat and modified intention-to-treat analysis was used for sustained virological respons. Results: The subtype distribution of chronic hepatitis C virus (HCV) genotype 6 in 53 cases of chronic hepatitis C infection were as follows: 22 cases of type 6a, 5 cases of type 6w, 5 cases of type 6xa, 3 cases of type 6v, 2 cases of type 6e, 2 cases of type 6r, 1 case of type 6xh, and 13 cases of special virus strains with undetermined genotype. The overall sustained virological response rate at 12 weeks after the drug withdrawal was 100%. Furthermore, HCV RNA was undetectable during the treatment period (4 weeks), at the end of treatment and after the treatment (24 weeks). There were seven cases of adverse events, mainly including fatigue, anorexia, and mild anemia; however, no serious adverse events were reported. Conclusion: Sofosbuvir-based regimen combined with ribavirin or velpatasvir cannot only achieve high response rate to HCV subtype 6a, but also obtain a good sustained virological response to the rare prevalent sub-genotypes and special virus strains of HCV genotype 6, with mild adverse reactions and acceptable safety profile.

Objective: To evaluate the clinical therapeutic effect of electroacupuncture (EA) at Dong 's Sanqixue combined with auricular point sticking on post-operative complications of complex anal fistula., Methods: The data of 318 patients undergoing anal fistula surgery were analyzed retrospectively. In accordance with whether accepted the combined treatment with EA at bilateral Dong 's Sanqixue and auricular point sticking or not after operation, they were divided into an observation group (157 cases) and a control group (161 cases). At the ratio of 1︰1, the nearest neighbor matching method was adopted to match 125 pairs of patients. The score of visual analogue scale (VAS) on day 1, 7 and 14 after operation, the incidence of urine retention on day 1 and 3 after operation, the anorectal dynamical indexs (anal resting pressure, rectal resting pressure, anal maximum systolic pressure and rectal minimum sensitivity) before and after operation, as well as the clinical therapeutic effect were compared in the patients between the two groups separately., Results: For VAS score, there was an interaction between therapeutic method and treatment duration ( P <0.05); the main effect was significant for therapeutic method ( P <0.05), while, it was not significant for treatment time ( P >0.05). On day 7 and 14 after operation, VAS scores were lower than those on day 1 in the two groups ( P <0.05), and VAS scores on day 7 and 14 after operation in the observation group were lower than those in the control group ( P <0.05). On day 3 after operation, the incidence of urine retention in the observation group was lower than that in the control group (0.8% [1/125] vs 9.6% [12/125], P <0.05). On day 14 after operation, anal resting pressure, anal maximum systolic pressure and rectal minimum sensitivity in the observation group were lower than those in the control group ( P <0.05), and rectal resting pressure was higher than that in the control group ( P <0.05). In 1 month after operation, the total effective rate was 96.0% (120/125) in the observation group, higher than 80.8% (101/125) in the control group ( P <0.05)., Conclusion: Electroacupuncture at Dong 's Sanqixue combined with auricular point sticking therapy alleviates pain, reduces the incidence of urine retention, improves anal defecation function and clinical therapeutic effect in the patients after complex anal fistula surgery.

Boao Lecheng International Medical Tourism Pilot Area is the only administrative area in China where the pilot application of real-world data is performed. Based on the special healthcare policy in Boao Lecheng, conducting real-world data study to provide real-world evidence for the clinical evaluations and approvals of innovated medical products has become an important field that supports the reform of China's evaluation and approval system of medical products. Trustworthy real-world evidence needs to rely on both high-quality real-world data and reasonable and rigorous study designs. Based on the real-world data research guidelines and specifications issued by relevant academic research and regulatory authorities both at home and abroad, combined with the special policy environment of Boao Lecheng and previous practice experience, this paper summarizes the study designs of real world data in Boao Lecheng and discusses the key considerations of different study design in the context of special healthcare policies in Boao Lecheng in order to provide reference for the further study of real-world data.

Objective: To explore the diagnostic process and outcomes of patients with aplastic anemia (AA) who received outpatient treatment in a real-world setting. Methods: The diagnostic processes, treatment regimens, and outcomes of 176 patients with AA treated in outpatient centers from January 2018 to December 2019 were reviewed. Results: The median interval from the onset of symptoms to the first visit was 7 (5-120) months. Complaints during the first visit included bleeding (52.3% ) , anemia (51.7% ) , and infection (6.8% ) . For diagnosis, 168 patients (95.5% ) underwent bone marrow aspiration; however, only 22 of them (17.1% ) consented aspiration in multiple sites (sternum) . The completion rate of bone marrow biopsy was 85.1% (143/168) ; flow immunophenotype and karyotype analyses were performed on 59.5% (100/168) and 58.9% (99/168) of AA patients, respectively, and the culture of clonal forming units by bone marrow mononuclear cells was performed on 26.8% (45/168) of AA patients. The most preferred regimen was cyclosporine combined with androgen and levamisole (43.8% , 77 patients) , followed by cyclosporine combined with androgen (25.6% , 45 patients) . Cyclosporine alone was administered in 24 patients (13.6% ) and androgen alone in 16 patients (9.1% ) . Furthermore, 14 patients (7.9% ) did not consent to any drugs or only chose traditional Chinese medicine. The patients were divided according to the frequencies of follow-up: regular follow-up group (≥4 times/year, n =130) and irregular group (<4 times/year, n =46) . The former had a higher 6-month remission rate (52.5% vs 28.0% , P =0.005) , a greater high-quality remission rate in 12 months (40.7% vs 16.7% , P =0.027) , and a lower relapse rate in 24 months (4.4% vs 36.4% , P =0.001) . Conclusion: In real-world settings, bone marrow aspiration in multiple sites should be addressed in outpatient treatment for AA diagnostic work-up, including PNH clone screening, flow immunophenotype, chromosome karyotype analysis, and culture of clonal forming units. Patients with AA who follow regular visits were more likely to achieve high-quality remission and a lower relapse rate. Visits at least four times per year are recommended for AA patients undergoing outpatient treatment.

To investigate the extensive application of Injection of Xuesaitong(lyophilized) in clinical real world study, and provide basis for clinical guidance on rational drug use and improvement of drug instructions. A prospective, multi-center, large-sample hospital centralized monitoring method was adopted to collect the general information and medication information of all patients who received Injection of Xuesaitong(lyophilized) during the study period in the respective monitoring units. Data analysis was performed using SAS 9.1 software. This study included 79 hospitals, with 30 097 patients being recruited. The patients who met the indications for stroke and hemiplegia accounted for 31.18%, those who experienced indications of chest pain and heartache accounted for 23.15%, and patients with central retinal vein occlusion indication accounted for 0.53%. The minimum single dose of Injection of Xuesaitong(lyophilized) was 20 mg, the maximum single dose was 1 000 mg, and the average single dose was(383.31±78.10) mg. 69.96% of the patients used 0.9% sodium chloride as the menstruum, 28.78% of the patients used 5% glucose as the menstruum, and 0.19% of the patients used 10% glucose as the menstruum. The minimum time for Injection of Xuesaitong(lyophilized) to dissolve is 0 min, 120 min maximally, and(14.26±13.73) min on an average basis. Patients using Injection of Xuesaitong(lyophilized) by intravenous drip accounted for 99.93%, with a slowest drip rate of 10 drops per min, fastest drip rate of 80 drops per min, and an average of(43.91±10.77) drops per min. Injection of Xuesaitong(lyophilized) was used for a minimum of 1 day and a maximum of 80 days, with an average of(8.22±5.12) days. Combined use with other injections accounted for 80.67%, 47.14% of them flushed the tube and 3.31% of them replaced infusion sets. The study found 40 cases of adverse reactions in patients with Injection of Xuesaitong(lyophilized), with an overall incidence of 0.13%(0.09% to 0.17%) for adverse reactions. In the real world application, the usage of Injection of Xuesaitong(lyophilized) basically meets the requirement of drug instructions in terms of indications, dosages, and methods of administration. However, it still needs to be improved in standardizing the selection of the menstruum, drip rate, course of treatment, and the combined usage of medicine.