基于队列多重随机对照试验的中医药临床评价创新方法及适用性评价方法的探索构建

Exploration and construction of innovative methods and applicability evaluation methods for traditional Chinese medicine clinical evaluation based on cmRCT

2019年中国科协发布了20个重大科学问题和工程技术难题,其中之一为“中医药临床疗效评价创新方法与技术”。《“十四五”中医药发展规划》提出要加强中医药临床疗效评价研究。中医药临床疗效评价创新方法与技术是一个亟待解决的关键问题。2010年,BMJ杂志首次提出“队列多重随机对照试验(cmRCT)”,其作为新兴的实用性临床试验设计方法,具有招募效率高、人群代表性较好、节省资源等优势。文章通过梳理cmRCT相关研究,创新性融合倾向性评分匹配(PSM)、广义线性混合模型(GLMM),以处理混杂偏倚与重复测量问题,初步构建一套基于cmRCT的中医药临床评价方法;并构建了适用性评价的基本维度与要素,以期为中医药临床评价创新研究提供新的方法学参考。

In 2019,the Chinese Association for Science and Technology(CAST)released 20 major scientific issues and engineering technical problems,one of those is‘innovative methods and technologies for clinical efficacy evaluation of traditional Chinese medicine’.The 14th Five-Year Plan for the Development of Traditional Chinese Medicine proposes to strengthen research on the clinical efficacy evaluation of traditional Chinese medicine.In 2010,the journal BMJ first proposed the‘cohort multiple randomised controlled trial(cmRCT)’,which is an emerging practical clinical trial design method with the advantages of high recruitment efficiency,better population representation and resource saving.We have compiled relevant studies on cmRCT,innovatively integrated propensity score matching(PSM)and generalized linear mixed model(GLMM)to deal with the problems of confounding bias and repeated measures,and initially constructed a set of clinical evaluation methods based on cmRCT;and constructed the basic dimensions and elements of applicability evaluation,in order to provide a new methodological reference for innovative research on clinical evaluation of traditional Chinese medicine.