CONSORT-中药复方声明在国外中药复方RCT中的应用分析和临床科研启示

Application analysis and clinical research enlightenment of CONSORT-Chinese medicine compound declaration in RCT of Chinese medicine compound abroad

依据CONSORT–中药复方声明对国外中医药RCT进行质量评价,以期对中医药RCT质量的提高及优化试验研究提供信息参考。系统检索Pub Med、Cochrane图书馆、Embase三大数据库收录的国外中医药RCT文献,由3名研究者独立筛选文献,并提取相关条目进行质量评价。共纳入59篇文献,依据CONSORT–中药复方声明条目逐一评价,2017年后在方法学部分中受试者、分配隐藏、盲法等条目相较之前确有提升,但结果及声明部分相关情况仍不尽人意,CONSORT-中药复方声明应用普及率仍较低。笔者依据统计结果,结合当下中医药RCT的研究现状,分析、讨论、探究其相关原因,建议中医药临床试验应遵循三原则,严谨试验方案并严格执行,同时对中医药临床实践和科研启示更加有针对性地提出指导性建议。

According to the CONSORT-Chinese medicine compound declaration,the quality of foreign Chinese medicine RCT was evaluated in order to improve and optimize the quality of Chinese medicine RCT experimental studies provide information reference.Foreign Chinese medicine RCT literature collected in Pub Med,Cochrane Library and Embase were systematically searched.Three researchers independently screened the literature and extracted relevant items for quality evaluation.A total of 59 literatures were included and evaluated one by one according to CONSORT-Chinese medicine compound declaration items.After 2017,subjects,assignment concealment,blind method and other items in the methodological part were improved compared with before,but the results and the related situation of the declaration part were stil unsatisfactory,and the popularity rate of application of CONSORT-Chinese medicine compound declaration was still low.Based on the statistical results and the current research status of RCT of traditional Chinese medicine,the author analyzed,discussed and explored the relevant reasons,and suggested that clinical trials of traditional Chinese medicine should abide by the three principles,strictly implement the trial plan,and put forward more targeted guiding suggestions for clinical practice and scientific research of traditional Chinese medicine.