中药复方治疗复发性流产随机对照试验报告的质量评价及思考  

Quality Evaluation and Thinking of RCT Reports of TCM Compounds in Treatment of Recurrent Pregnancy Loss

作　　者：邓楹君 刘胜京 赵丰 朱旭华[2] DENG Yingjun;LIU Shengjing;ZHAO Feng;ZHU Xuhua(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]中国中医科学院望京医院,北京100102

出　　处：《中国中医药信息杂志》2023年第3期51-56,共6页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：国家自然科学基金面上项目(82174392);中国中医科学院科技创新工程重大攻关项目重点项目(CI2021A00901)。

摘　　要：目的评价中药复方治疗复发性流产随机对照试验(RCT)的报告质量,以期为今后的临床实践和研究提供方法学参考。方法检索中国知识资源总库(CNKI)、中文科技期刊数据库(维普网)、万方数据知识服务平台(万方数据)、中国生物医学文献数据库(CBM)2011年1月-2021年12月公开发表的关于中药复方治疗复发性流产的RCT,以CONSORT-中药复方和改良Jadad量表为依据,2名研究者独立筛选文献后对入组的RCT报告质量进行评价。结果纳入相关RCT文献51篇,CONSORT-中药复方评价显示:60.78%的文献采用随机数字表法分组,但均并未具体说明随机数字表法的实施办法,所有试验均未设计盲法,94.12%的文献说明随机分配到各组的受试者例数,但仅有7.84%的文献说明脱落、退出患者例数及理由,25.49%的文献提及安全性评估和不良事件发生情况,11.76%讨论了试验的局限性,35.29%讨论了试验结果的可推广性,所有文献均无适当的关键词、完整的干预措施、合理的分配隐藏实施方式、受试者流程图、临床试验注册及研究方案和资助说明。改良Jadad量表评价显示:94.12%的文章改良Jadad量表评分均低于4分,仅3篇(5.88%)文献评分为4分,无5分以上的文献。结论目前国内中药复方治疗复发性流产的RCT报告质量普遍偏低,在随机和盲法的设计上有明显不足,在采纳和运用其结果时应谨慎;研究者应遵循CONSORT声明、改良Jadad量表进行方案设计、注册、实施及报告,充分考虑中药复方治疗复发性流产的临床特点,合理设计和报告结局评价指标及结果。Objective To evaluate the quality of reports of RCTs in the treatment of recurrent pregnancy loss with TCM;To provide methodological reference for future clinical practice and research.Methods The RCTs about TCM compounds in the treatment of recurrent pregnancy loss published in CNKI,VIP,Wanfang Data and CBM from January 2011 to December 2021 were retrieved.Based on CONSORT-CHM Formulas 2017 and modified Jadad scale,the quality of RCT reports was evaluated by two researchers after screening literature alone.Results Totally 51 RCTs were included.CONSORT-CHM Formulas 2017 compound evaluation showed that 60.78% of the articles were grouped by random number table method,but the implementation method of random number table method was not specified.All the tests were not designed with blind method;94.12% of the articles described the number of subjects randomly assigned to each group,but only 7.84% of the articles explained the number and reasons of patients who dropped out;25.49% of the articles mentioned safety assessment and adverse event;11.76%discussed the limitations of the test;35.29% discussed the popularization of the test results.There were no appropriate keywords,complete intervention measures,reasonable allocation of hidden implementation methods,participant flow chart,clinical trial registration,research programs and funding instructions in all literature.Evaluation of modified Jadad scale showed that 94.12% of articles scored below 4 points;only 3 articles(5.88%)scored 4 points;there were no articles more than 5 points.Conclusion At present,the quality of RCT reports about TCM compounds in the treatment of recurrent pregnancy loss is generally low,and there are obvious deficiencies in the design of random and blind methods.The results should be carefully adopted and applied.Researchers should follow the CONSORT statement and modified Jadad scale for scheme design,registration,implementation and reporting,fully consider the clinical characteristics of TCM compounds in the treatment of recurrent pregnancy l

关 键 词：复发性流产 中药复方 随机对照试验 质量评价 

分 类 号：R2-05[医药卫生—中医学] R271.952.421