中成药治疗糖尿病肾病的随机对照临床试验现状及质量评价

Summary and evaluation of randomized controlled trial on Chinese patent medicine treatment of diabetic kidney disease

[目的]对中成药治疗糖尿病肾脏疾病(DKD)的临床随机对照试验(RCT)进行系统的收集与分析,对其进行评估并总结证据全貌,为后续临床研究开展和相关研究提供参考。[方法]基于中医药循证研究证据库系统(EVDS)下数据库的收录,并补充检索中国知网(CNKI)、维普(VIP)等数据库,检索时间为建库至2022年12月31日,纳入中成药治疗DKD的RCT,对其进行统计分析,并从发表情况、纳入患者情况、方法学质量等方面进行评估。[结果]纳入RCT 2086篇,纳入患者情况>100例的RCT研究共529篇;涉及中成药160种;应用计数指标共计20种,计量指标381种;97.75%文章存在研究者和受试者盲法缺失;86.05%文章存在其他偏倚风险;仅6篇RCT(0.19%)报告了试验注册,4篇(0.19%)报告了样本量估算。[结论]中成药治疗DKD总体方法学质量不高,主要问题包括:试验注册、伦理审批等环节缺失;在分配隐藏、其他偏倚等方面报告存在明显不足。后续相关临床研究应重视并解决以上问题,规范相关的临床研究设计和实施,以期为临床实践提供数据支持和为进一步开展后续相关研究提供参考。

[Objective]To systematically collect,analyze and evaluate the clinical randomized controlled trial(RCT)of proprietary Chinese patent medicine in the treatment of diabetic kidney disease(DKD),summarizing the whole picture of evidence and providing reference for subsequent clinical studies and related studies.[Methods]Literature resources were based on the evidence-based research of traditional Chinese medicine evidence database system(EVDS)under the intelligent proprietary Chinese medicine clinical evidence database(AICED-CPM),we supplementary searched six common databases,including CNKI,VIP and so on,with the search period from the establishment of the database to December 31,2022.The type of disease,time to publication,sample size,intervention/control settings,evaluation methods and methodological quality were analyzed and evaluated.[Results]The 2086 RCTs were included,of which 529 RCTs with>100 patients were included;a total of 160 kinds of proprietary Chinese medicines were involved;a total of 20 counting indicators and 381 measures were applied;in terms of methodology,97.75%of articles had researcher and subject blinding omissions;86.05%of articles had other bias risks;and only 6 RCTs(0.29%)reported trial registration and 4(0.19%)reported sample size estimation.[Conclusion]The overall methodological quality of proprietary Chinese medicines for DKD was low,and the main problems included missing trial registration and ethical approvals;there were significant deficiencies in the reporting especially of 2 aspects:allocation concealment,other biases and so on.Subsequent relevant clinical studies should pay attention to and solve the above problems,standardize the design and implementation of relevant clinical studies,highlight the clinical value,and improve the quality of evidence.