Objective To overview the systematic review(SR) of efficacy and safety of fecal microbiota transplantation (FMT) in clostridium difficile infection (CDI). Methods PubMed, The Cochrane Library, EMbase, CNKI, VIP, WanFang Data databases and related website (http://scholar.google.com/) were electronically searched to collect SR and meta-analysis on FMT of CDI. The quality of collected documents and evidences were evaluated by OQAQ (Overview Quality Assessment Questionnaire) and GRADE (Grading of Recommendations Assessment, Development and Evaluation), respectively. Results Eleven SRs were included, in which 4 were completed by meta-analysis. The results of OQAQ showed that the score of one review was 2, the others SR received scores from 5 to 9. There were 9 SRs had reported the CDI clinical resolution rate (CRR), of which one SR showed CRR was 36.2%, and the others showed CRR were about 90%. Compared to upper gastrointestinal FMT, all studies showed lower gastrointestinal FMT (colonoscopy, enemas, etc.) had a higher CRR. The outcomes of selection and random fecal donor had no significant differences, and authors suggested that there should be made a standardization of donor screening table for safe fecal. Present evidence showed FMT were safety, and the majority of adverse events of FMT appeared to be mild, self-limiting and gastrointestinal in nature. The GRADE quality level of SR indicated from very low to moderate. Conclusion FMT, as a treatment for CDI, shows significant efficacy and safety, but need more high-level evidences because of its clinical translation difficulties. The study also give a reference to develop standardized clinical pathways of FMT to policy researchers.
Objective To evaluate the efficacy and safety of Celecoxib and Naproxen for treating osteoarthritis or rheumatoid arthritis.Methods Such databases as EMbase, PubMed, The Cochrane Library, Chinese Biomedical Literature Database (CBM), China Journal Full-text Database (CJFD), and Chinese Scientific Journal Full-text Database (CSJD) were searched to collect the randomized controlled trials (RCTs) of Celecoxib and Naproxen for treating osteoarthritis or rheumatoid arthritis. Two reviewers independently assessed the quality of the included studies and extracted the data. The Review Manager (version 5.0) software was used to analyze the data. Results Four RCTs involving 2 931 patients were included. The results of meta-analyses were as follows: a) There were significant differences in the dose of Celecoxib and Naproxen for treating rheumatoid arthritis or osteoarthritis; b) There was no significant difference in gastrointestinal reaction between the Celecoxib group and the placebo group (RR=1.29, 95%CI 0.93 to 1.79); c) The were significant differences in gastrointestinal reaction between the Celecoxib group and the Naproxen group (RR=0.78, 95%CI 0.64 to 0.95); d) There were significant differences in inducing the severity of Stomach and Duodenum Endoscopy Score between the Celecoxib group and the Naproxen group when treating rheumatoid arthritis or osteoarthritis (RR=1.29, 95%CI 0.93 to 1.79). As the Intention-To-Treat (ITT) analysis showed, there were significant differences in inducing the severity of gastrointestinal reaction between the Celecoxib group and the Naproxen group when treating rheumatoid arthritis or osteoarthritis (RR=0.84, 95%CI 0.77 to 0.92). Conclusion Compared with Naproxen, there are significant differences in efficacy for treating rheumatoid arthritis and osteoarthritis with Celecoxib in different doses. The Celecoxib has no significant difference in gastrointestinal reaction compared with the placebo group. The Celecoxib group has fewer gastrointestinal side-effects as compared with the Naproxen group, so it can be used to treat rheumatoid arthritis and osteoarthritis in clinic. The results still need to be confirmed by high-quality RCTs.
ObjectiveTo review the current status of case studies on drug comprehensive clinical evaluation published in China in the past decade, providing references for the standardized implementation of evaluation. MethodsA scoping review was conducted on the published cases of drug comprehensive clinical evaluation in China. The analysis was carried out from themes, dimensions, methods, and quality control. Descriptive analysis was used to analyze the evaluation themes, dimension, method, and quality control of the included studies. Meanwhile, VOSviewer 1.6.20 software was used to conduct co-occurrence network analysis of author's affiliation and evaluation dimensions. ResultsThe research on comprehensive drug clinical evaluation has developed the fastest in Beijing. Medical institutions, universities, and scientific institutions are the main research institutions. Universities and their affiliated hospitals have stronger collaboration, while some local hospitals show research isolation. The evaluation themes focus on chronic diseases and cancer, with some repetitions. The evaluation methods mainly rely on descriptive analysis. In nearly half of the cases, evidence-based medicine methods are inadequately applied. Only about 5% of the cases have conducted real-world research. For cases with the same theme, results may conflict due to differences in methods or data sources. The value integration mainly relies on quantitative scoring, which is lacking in 37.05% cases. Only 14.03% of the cases report quality control. In 31.87% of cases, the data provided by pharmaceutical companies were used, with a lack of conflict-of-interest disclosures. ConclusionAlthough the comprehensive clinical evaluation of drugs in China has developed rapidly, there are problems such as non-standardized methods and differences in data sources. It is necessary to improve the scientificity and decision-making value of evaluation results by coordinating theme selection, strengthening quality control, and developing reporting guideline.