中医药临床试验过程中随机化的实现方法及改进思考

Implement and improvement suggestions of randomization in the process of traditional Chinese medicine clinical trails

近年来,我国广泛开展中医药干预多病种的临床随机对照试验,其中随机化设计尤为重要。但是,我国中医药临床随机对照试验的方法学与报告质量普遍不高,尤其是在随机化方面认识不足。对于随机化分配方法、分配隐匿的了解较差,实施不严格。本文在梳理国内外临床试验中的随机化理论、随机化分配方法、分配隐匿方法的基础上,针对我国中医药临床随机对照试验中在随机化方面出现的问题进行阐述并深入思考,为规范临床试验的随机化过程提出可行性建议。

Recently,the randomized controlled trials(RCTs)in traditional Chinese medicine(TCM)intervention in multiple diseases have been widely developed in China,in which randomization plays an irreplaceable role.However,the methodology and reports of RCTs in TCM still keep a poor quality,specifically the lack of awareness of randomization.Most researchers know little about randomized methods and allocation concealment,and have no strict implementation.Therefore,on the basis of reviewing the randomization theory in clinical trials at home and abroad,the randomization allocation method and the allocation concealment method,the problems of randomization in clinical RCTs of TCM in China were expounded and deeply considered.This paper suggested feasibility ideas to standardize the randomization process of clinical trials.