中医药治疗慢性胆囊炎随机对照试验文献的质量评价

目的 评价中医药治疗慢性胆囊炎的随机对照试验(randomized controlled trials,RCT)的文献质量.方法 计算机检索MEDLINE、EMBASE、Cochrane图书馆对照试验注册库(CENTRAL)、中国临床注册中心、中国生物医学文献数据库( CBM),中国期刊网全文数据库(CNKI)、中文科技期刊数据库VIP及万方数据库.检索不受语种限制,时间截止至2009年9月.提取有效数据,对文献进行质量评价.结果 共检索得到相关文献512篇,涉及随机临床对照试验57篇.排除不符合纳入标准的49篇文献,最终纳入8篇文献.根据赋予分值的CONSORT for TCM的22项标准进行评价.8篇分值均低于17.5分,不到总分的50％.结论 目前中医药治疗慢性胆囊炎的临床研究报告质量尚低,还不能为临床应用提供可靠的依据.

Quality evaluation on literatures of randomized controlled trial in treating chronic cholecystitis with traditional Chinese medicine

【Objective】 This study proposes a quality evaluation of the research literatures involving randomized controlled trials(RCT) of TCM treatment of chronic Cholecystitis.【Methods】 We searched MEDLINE,PubMed,EMBASE,Cochrane Library(CENTRAL),CBM,CNKI,VIP,and Wanfang.No language restrictions were applied.Valid data were extracted and applied to evaluate the quality of the retrieved literatures.【Results】 Altogether 512 articles were retrieved from the databases with 57 pieces involving randomized controlled clinical trial,further excluding 49 pieces that fail to meet the selection criteria,8 pieces of articles were finally included into this study and evaluated according to scored 22 criteria of CONSORT for TCM with the results that the score for each article was below 17.5 points and less than 50% of the full score.【Conclusion】 Current clinical research literatures on TCM treatment of chronic Cholecystitis exhibit low quality level so that they can not provide reliable basis for clinical application.