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OBJECTIVE: At present, there are various surgical repair strategies for the lateral stability of chronic ankle instability after the injury of the lateral collateral ligament of the ankle, but the specific repair strategy to maximize the recovery of lateral stability of the ankle still lacks of evidence-based medical evidence. Based on this, for the first time, this paper systematically evaluated the effects of four popular repair strategies to restore the lateral stability of chronic ankle instability using the network meta-analysis method. METHODS: Computer retrieval was conducted on CNKI, WanFang, VIP, PubMed, Embase, Web of Science and Cochrane Library. The retrieval time was from the establishment of each database to December 2022. The randomized controlled trials or clinical controlled trials on different repair strategies to recover chronic ankle instability after injury of the lateral ligament of the ankle were included. The literature was screened and extracted. The literature quality was evaluated and data were analyzed using RevMan 5.4, R4.2 and Stata 14.2 software. RESULTS: Twelve studies (including 10 randomized controlled trials and 2 cohort studies) were included. A total of 673 patients with chronic ankle instability were involved in 4 repair strategies. The observation indicators were: anterior talar translation distance and talar tilt angle of ankle joint stress X-ray film (hereinafter referred to as anterior talar translation distance and talar tilt angle). The results of network meta-analysis showed that: (1) In terms of anterior talar translation distance, the sequence of reticular meta-analysis results from inferior to superior was anatomical repair > anatomical repair + enhancement of inferior extensor retinaculum > internal brake anatomical reconstruction > autologous/allogeneic tendon anatomical reconstruction. (2) In terms of talar tilt angle, the sorting results of reticular meta-analysis from inferior to superior were as follows: anatomical repair > anatomical repair + inferior extensor retinaculum enhancement > internal brace anatomical reconstruction > autologous/allogeneic tendon anatomical reconstruction. CONCLUSION: Anatomical reconstruction strategy of autologous/allogeneic tendon is the first in improving anterior talar translation distance and talar tilt angle, suggesting that this strategy may have the best effect in restoring the stability of chronic joint instability after injury of the lateral ligament of ankle, but more large sample, multicenter, double-blind randomized controlled trials are still needed in the future to further confirm. [ABSTRACT FROM AUTHOR]

Interstitial lung disease (ILD) is one of common pulmonary complications of connective tissue disease (CTD), which seriously affects quality of life and significantly increases risk of death of patients with CTD. However, related immune mechanism of CTD-ILD is not clear yet. This paper systematically reviews involvement of various cytokines in pathogenesis of CTD-ILD. Pathogenesis of CTD-ILD and correlation between cytokines and clinical indicators were discussed from cell level, animal model and clinical trials, to investigate whether cytokines can be targeted for treatment of CTD-ILD to help guide future research and clinical practice. [ABSTRACT FROM AUTHOR]

Coronavirus disease 2019 （COVID-19） is highly infectious， severe and critically ill patients have high mortality and lack specific treatment， so it is urgent to find safe and effective treatment methods. Mesenchymal stem cells （MSCs） have biologi⁃ cal properties such as immune regulation， tissue repair， regeneration， migration and homing， antiviral and anti-inflammatory. At present， studies on use of MSCs in treatment of COVID-19 have been gradually carried out. This paper reviews pathogenesis of 2019 novel coronavirus（ 2019-nCoV）， potential regulatory mechanisms and challenges of MSCs in treatment of COVID-19. [ABSTRACT FROM AUTHOR]

There is no specific biomarker for triple-negative breast cancer (TNBC), and chemotherapy remains as backbone but with limited efficacy and more side effects. 10%-21% TNBC are elderly patients with high prevalence of concomitant cardiocerebrovascular and renal complications, which may lead to intolerance of chemotherapy. How to properly treat these elderly TNBC patients becomes a big challenge during daily clinical practice. To date, few clinical trials specifically focus on elderly TNBC patients, thus no enough evidence-based safety and efficacy data are provided to support the proper therapy to this population. There are also challenges and controversies in the diagnosis and treatment. Elderly TNBC patients have special age-related disease characteristics and high non-cancer related mortality. Therefore, it is very important to balance survival benefit and quality of life during the treatment. This paper summarized data of the epidemiology, tumor biological behavior, current diagnosis and treatment status and the huge unmet medical needs of elderly TNBC patients, and explored the benefits of novel antibody-drug conjugate (ADC), to provide certain guidance on systemic treatment strategies for elderly TNBC patients. [ABSTRACT FROM AUTHOR]

Breast cancer has become the most common type of cancer in the world, harming the majority of women's physical and mental health and challenging clinical prevention and treatment of tumors. With the in-depth research on the pathogenesis and metastasis mechanism of breast cancer, as well as the development of translational research such as multiomics technology and tumor immunity, it has been proved that breast cancer has highly heterogeneous molecular and clinical characteristics. The clinical treatment methods of different subtypes of breast cancer are different and related, and the achievements in the field of breast cancer clinical research are fruitful. In 2022, results of important clinical trials have achieved for different subtypes of breast cancer. For the neo-adjuvant treatment of human epidermal growth factor receptor 2 (HER2) positive breast cancer, the PHEDRA study provided new adjuvant treatment options for HER2 positive breast cancer patients; And for the HER2 positive metastatic breast cancer, PHILA study and SYSUCC-002 study results provided reference for clinicians. For patients with brain metastasis, PERMEATE study showed that pyrrolitinib combined with capecitabine regimen was to become the preferred treatment scheme for HER2 positive brain metastasis population, especially for patients with brain metastasis without local radiotherapy. In hormone receptor positive breast cancer, a number of clinical trials (monarchE study, DAWNA-1 study, MONALEESA series of studies, etc.) of arbacilli, daracilli, rebosilli and others reported their efficacy on visceral metastasis. For triple-negative breast cancer, many clinical trials are under way. This paper aimed to review the recent advances in clinical research on breast cancer in the past year. [ABSTRACT FROM AUTHOR]

Breast cancer is the most common cancer in women worldwide with rising prevalence. The human epidermal growth factor receptor 2 (HER2) is crucial to the biological behavior and pathogenic mechanism of breast cancer. Approximately 45%- 55% of all subtypes of breast cancer have low expression of HER2, which are classified as HER2 immunohistochemistry staining 1+ or 2+ and in situ hybridization (ISH) negative. Although in most cases, HER2 low expression (HER2-low) breast cancer is still classified as HER2 negative or triple negative in clinical practice, HER2-low differs from HER2 not detected (HER2-0) breast cancer not only in HER2 expression levels, there are also differences in terms of estrogen receptor (ER) status, primary tumor volume, lymph node involvement, and pathologic complete response (pCR) following neoadjuvant therapy and disease-free survival (DFS). In clinical trials targeting early-stage HER2-low breast cancer, the NSABP B-31 and N9831 trials demonstrated the possibilities for breast cancer patients to benefit from adjuvant trastuzumab therapy; however, in phase III prospective randomized controlled study NSABP B-47, trastuzumab did not alter invasive disease-free survival (iDFS), 5-year interval without distant recurrence, or overall survival (OS) in patients with HER2-low breast cancer. Recent years have seen the emergence of clinical trials for targeted treatments for advanced HER2-low breast cancer, focusing mostly on trastuzumab, lapatinib, and antibody-drug conjugate (ADC), such as trastuzumab emtansine (T-DM1), DS-8201 (also known as trastuzumab deruxtecan, T-DXd, Enhertu), and SYD985. Phase III trial CALGB9840 demonstrated a lack of therapeutic effect of trastuzumab and a narrow therapeutic window that could not be overcome by changing the dose of lumretuzumab in HER2 non-over-expressed breast cancer, respectively. Two randomized phase III trials (EGF30001 and EGF100151) both found that receiving lapatinib did not improve progression-free survival (PFS) in patients with HER2-low breast cancer. T-DM1 sensitivity was initially observed in patients with HER2-low breast cancer in the single-arm phase II studies 4258g and 4374g, but results were still uncertain because of the small number of patients. The phase III clinical study DESTINY-Breast04 proved the safety and efficacy of DS-8201 (5.4 mg/kg) in HER2-low metastatic breast cancer. The phase I clinical trial proved the efficacy and safety of 1.2 mg/kg SYD985 intravenously in HER2-low breast cancer. Additionally, there are currently ongoing clinical trials for several novel anti-HER2 therapeutics, including novel ADC drugs (RC48-ADC, ARX788, A166, etc.), bispecific antibodies (KN026, ZW25, ertumaxomab, etc.), and breast cancer vaccines (nelipepimut-S, GP2, AE37, etc.). In this paper, we will review the major clinical trials of targeted therapies for HER2-low breast cancer. [ABSTRACT FROM AUTHOR]

Objective To analyze the global registration of osteosarcoma clinical trials, to understand the research status and trend of the field, and to provide the latest information for osteosarcoma research and clinical diagnosis and treatment. Methods The data of osteosarcoma clinical trials registered in ClinicalTrials.gov from 2001 to 2021 were collected and statistically analyzed in terms of regional distribution, annual trend, trial progress, research type, clinical stage, and number of participating institutions. Results From 2001 to 2021, a total of 514 global osteosarcoma clinical trials were registered, mainly in North America and Europe. Among them, 416 (80.9%) were interventional clinical trials, 87.0% (362/416) were drug⁃related treatments, and 127 were anti⁃tumor drug studies. The results showed that only 147 (35.3%) interventional clinical trials had been completed, including 71 (48.3%) published papers and 33 (46.5%) published trial results. Compared with 2001-2011, the proportion of interventional clinical trials for osteosarcoma registered in Asia increased from 6.1% (10/163) to 15.0% (38/253) between 2012 and 2021, and the proportion of pre⁃recruitment registrations increased from 1.2% (2/163) to 43.9% (111/253), However, the number of phase Ⅱ clinical trials still accounted for the largest propor⁃ tion in these two periods, which were 46.0% (75/163) and 37.9% (96/253), respectively. Conclusions The majority of global osteosarcoma studies are interventional clinical trials, mainly focusing on drug⁃related treatments, and antitumor drugs are still the first choice for the osteosarcoma drug intervention research. The number of osteosarcoma interventional clinical trials registered in Asia has increased significantly, but the quality and quantity of these researches are still quite different from those in North America and Europe. [ABSTRACT FROM AUTHOR]

The ongoing global development of the COVID-19 epidemic has led to in-depth research on the disease, including therapeutic agents. As a promising specific antiviral agents, the neutralizing antibodies have been successfully applied on some viral infectious diseases. Currently, the development of neutralizing antibodies against SARS-CoV-2 is progressing rapidly internationally, several antibodies have been authorized for emergency use. This paper reviews the effect targets of neutralizing antibodies against SARS-CoV-2, the research progress of drugs, and the problems and shortcomings that need attention. [ABSTRACT FROM AUTHOR]

Objective　To evaluate the quality of the clinical trial literatures published on the treatment of COVID-19 with TCM, find out the shortcomings and put forward corresponding suggestions, in order to promote TCM against COVID-19. Methods　"COVID-19", "New Coronavirus Pneumonia", "TCM", "Chinese Medicine", "Clinical Trial", "Lianhua Qingwen", "Huoxiang Zhengqi", "Jinhua Qinggan", and other keywords were used to search relevant literatures in CNKI and PubMed database. Among the all the screened relevant literatures on the treatment of COVID-19 with TCM, the literature quality was assessed according to evaluation criteria of clinical trial literatures. Results　A total of 463 papers related to the treatment of COVID-19 with TCM were obtained. 440 papers on theoretical research on the network pharmacology mechanism of Chinese medicine treatment of COVID-19 were excluded. Among the 23 articles included in the quality analysis, there are 3 randomized controlled studies, 1 multi-center prospective randomized controlled trial, 2 disease case report trials, and 5 uncontrolled single arm studies, 5 controlled trials and 7 retrospective studies. In the period of more than half a year, although many clinical trial documents of TCM for the treatment of COVID-19 have been published, the clinical trial design reflected in most TCM clinical trials were not standardized. There are problems in "randomness and rationality", such as no control group, no randomization design, only case studies, no blinding method in controlling bias, and insufficient objectivity in the evaluation criteria of efficacy. All of these need to be improved. Conclusion　The treatment of new coronavirus pneumonia with TCM still requires more and standardized clinical trial verifications and publications to generate strong evidence-based results, such as adding control groups, increasing sample size, and using blinding methods to increase the credibility of clinical trials. [ABSTRACT FROM AUTHOR]

As a representative external therapy of traditional Chinese medicine, acupuncture is considered a valuable treasure with a history of thousands of years and it has been playing an important role in the process of disease prevention and treatment. In this paper, advices was given in order to improve the reliability of clinical evidence of acupuncture. The author summarized existing contradictions and issues by reviewing the status quo of evidence of acupuncture clinical trials. With the expansion of acupuncture disease spectrum, and emerging of high-quality clinical trials, promoting acupuncture clinical research evidence reliability would serve as the breakthrough point. Currently reliability of evidence in acupuncture clinical research has gained increasing international recognition. However, there remains room for improvement in the setting of sham acupuncture standard, attainment of practical evidence, and translation studies of clinical research result. In the future, it is advised to standardize sham acupuncture, achieve international consensus on operating standards, strengthen real world studies, as well as translate clinical trials result of acupuncture from multiple disciplinary perspectives, to further improve the influence of acupuncture in the process of internationalization. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To systematically evaluate the efficacy of programmed death-1/programmed death ligand-1（ PD-1/PD-L1） monoclonal antibody in gastric cancer or adenocarcinoma of the gastroesophageal junction.METHODS: PubMed,Embase,the Cochrane Library database and abstracts of American society of clinical oncology（ ASCO） conferences in the past three years,and European society for medical oncology（ ESMO） conferences in 2020 were retrieved to collect the prospective studies,phase Ⅱ and phase Ⅲ clinical trials( the study group was treated with PD-1/PD-L1 monoclonal antibody alone or in combination with chemotherapy,while the control group received chemotherapy or placebo. The retrieval deadline was Sept. 26 th,2020. The efficacy of different treatment regimens（ PD-1/PD-L1 monoclonal antibody treatment group compared with chemotherapy group,PD-1/PD-L1 monoclonal antibody treatment + chemotherapy group compared with chemotherapy group,and PD-1/PD-L1 monoclonal antibody treatment group compared with placebo group） was assessed by subgroup analysis,and forest plotting was performed by Stata SE 12 software. RESULTS: Seven clinical trials were ultimately enrolled,including three original papers,two abstracts of ASCO conferences and two abstracts of ESMO conferences.（ 1） The differences in overall survival（ OS）（ HR = 0. 96,95% CI = 0. 87-1. 07,P = 0. 451） and objective response rate（ ORR）（ RR = 0. 65,95% CI = 0. 39-1. 09,P = 0. 102） between the PD-1/PD-L1 monoclonal antibody treatment group alone and the chemotherapy group were not statistically significant,yet the difference in progression free survival（ PFS） between two groups was statistically significant（ HR = 1. 45,95% CI = 1. 17-1. 81,P = 0. 001）.（ 2） The differences of OS（ HR = 0. 84,95% CI = 0. 76-0. 94,P = 0. 001）,PFS（ HR = 0. 78,95% CI = 0. 70-0. 86,P = 0. 000） and ORR（ RR = 1. 24,95% CI = 1. 10-1. 39,P = 0. 000） between the PD-1/PD-L1 monoclonal antibody treatment + chemotherapy group and the chemotherapy group were statistically significant.（ 3） The differences of OS（ HR = 0. 63,95% CI = 0. 51-0. 78,P = 0. 000）,PFS（ HR = 0. 60,95% CI = 0. 49-0. 75,P = 0. 000） and ORR（ RR = 29. 93,95% CI = 1. 84-485. 72,P = 0. 017）between the PD-1/PD-L1 monoclonal antibody treatment group and the placebo group were statistically significant.CONCLUSIONS: The results of this study suggest that PD-1/PD-L1 monoclonal antibody combined with chemotherapy may benefit patients with advanced gastric cancer or adenocarcinoma of the gastroesophageal junction.Compared with placebo,PD-1/PD-L1 monoclonal antibody alone also benefits patients with advanced gastric cancer or adenocarcinoma of the gastroesophageal junction. However,compared with chemotherapy,patients with advanced gastric cancer or adenocarcinoma of the gastroesophageal junction may not get a more significant treatment effect from PD-1/PD-L1 monoclonal antibody,and more evidence is needed to confirm these findings. [ABSTRACT FROM AUTHOR]

OBJECTIVE: With the widespread use of intra-articular injection of sodium hyaluronate in the treatment of early and mid-stage knee osteoarthritis, the controversy about its efficacy has become increasingly fierce; however, there is a lack of evidence-based medical evidence from high-quality randomized controlled double-blind clinical trials. Based on the double-blind randomized controlled clinical trials regarding intra-articular injection of sodium hyaluronate in the treatment of early and mid-term knee osteoarthritis, this study aimed to clarify the objective curative effect and offer evidences for the clinical application. METHODS: CNKI, WanFang, Duxiu Academic, Chaoxing Journal, VIP, Web of Science, PubMed, and Scopus were searched for the relevant articles addressing intra-articular injections of sodium hyaluronate for knee osteoarthritis. And we screened double-blind randomized controlled clinical trials. According to the Cochrane Handbook 6.1, a risk of bias assessment tool (Risk of bias table 2, RoB2) was used to strictly evaluate the quality of the included papers, most of which are of high quality. The data of sensitive indicators that reflect therapeutic efficacy were extracted, and integrated for evaluation using the Meta-analysis. RESULTS: A total of 11 double-blind randomized controlled clinical studies were included, involving 3 034 patients. Meta-analysis results indicated that more OMERACT-OARSI responders of the sodium hyaluronate group than the control group at the end of each study (relative ratio (RR)=1.11, 95% confidence interval (CI): 1.05-1.18, P=0.000 6), at 3 months after injection (RR=1.10, 95 %CI: 1.02-1.18, P=0.02) and at 6 months after injection (RR=1.07, 95% CI: 1.01- 1.14, P=0.03). However, there was no significant difference between the two groups at 1 month after injection. Changes in the painful Visual Analogue Scale score relative to the baseline were significantly better in the sodium hyaluronate group than the placebo group at 1 (mean difference (MD)=2.71, 95% CI: 1.35- 4.07, P < 0.000 1) and 6 months after injections (MD=3.14, 95% CI: 0.81-5.47, P=0.008). However, there was no significant difference between the two groups at 3 months after injections (MD=0.42, 95% CI: -3.17 to 4.02, P=0.82). The overall patient satisfaction and the changes relative to the baseline in the sodium hyaluronate injection group were significantly better than those of the placebo group. However, there was no difference in the use of analgesics in emergency situations and treatment-related adverse events between the two groups. CONCLUSION: Based on double-blind randomized controlled clinical data, it is shown that intra-articular injection of sodium hyaluronate is effective for early and mid-term knee osteoarthritis patients half a year later, and can significantly improve joint pain and patient treatment experience. The long-term effect needs to be further confirmed. [ABSTRACT FROM AUTHOR]

Medical simulation provides reliable clinical program verification and experience accumulation for medical staff. The simulation of outer tissue materials in simulation plays an important role in the simulation of clinical trials, medical scientific research and teaching demonstration. Therefore, a kind of outer material formula of heart simulation model is studied in this paper. According to the different requirements of the region, the corresponding experimental optimization scheme is adopted. The materials of outer surface layer were optimized and investigated by orthogonal test, four factors, liquid silica gel, curing agent, amount of dye and curing time, were selected for index analysis and verification. The best proportions of the outer materials in the heart simulation model were obtained. Among them, the weight ratio of curing time is the most obvious, the weight of curing agent dosage is the second, and the weight of liquid silica gel and dye dosage is the least. The optimal propo1tion of liquid silica gel is 100 mL, the curing agent is 2 mL, the dye is 17 mL and the curing time is 2 h. Due to the support of orthogonal experiment data, each condition was investigated as a single factor variable. The optimum conditions are drying time 2 h, curing agent dosage 2. 5 mL, and liquid silica gel amount 100 mL. The second modification of the tissue functional area was compared with that of the sample after drying the 15 min, and the effect of the thick coating was good. [ABSTRACT FROM AUTHOR]

Albiglutide, a new type of GLP-1 receptor agonists, combined with GLP-1 receptors on the surface of the islet β cells,activate the cell membrane coupling G-protein regulation of intracellular signal transduction system, repair and promote the islet β cell function, increase the secretion of insulin, thus reduce blood sugar and glycated hemoglobin (HbA1c) levels. So it is an ideal drug for the treatment of Ⅱ diabetes. The current development of long-acting GLP-1 agonists have become the focus diabetes drugs in the nearly twenty years. In this paper, Albiglutide, a kind of new GLP-1 receptor agonists, has extremely market potential. It summarized research progress on its molecular structure, mechanism of action and clinical trials which include its dose research, pharmacokinetics, pharmacodynamics and side effects, etc. [ABSTRACT FROM AUTHOR]