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
吕健 1刘光宇 2赵晓晓 3刘征堂 4黄悦 4王慧婵 4付建华 2谢雁鸣3
作者信息
- 1. 中国中医科学院西苑医院国家药物临床试验机构,北京 100091;中国中医科学院西苑医院中药临床研究与评价重点实验室,北京 100091;中国中医科学院西苑医院国家中医心血管病临床医学研究中心,北京 100091
- 2. 中国中医科学院西苑医院国家中医心血管病临床医学研究中心,北京 100091
- 3. 中国中医科学院中医临床基础医学研究所,北京 100700
- 4. 中国中医科学院西苑医院国家中医心血管病临床医学研究中心,北京 100091;中国中医科学院西苑医院老年病科,北京 100091
- 折叠
摘要
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.
Abstract
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.
关键词
队列多重随机对照试验/适用性评价/倾向性评分匹配法/重复测量分析模型/临床评价创新方法Key words
Cohort multiple randomized controlled trial/Applicability evaluation/Propensity score matching/Repeated measures analysis models/Innovative methods for clinical evaluation引用本文复制引用
基金项目
国家中医心血管病临床医学研究中心专项科研基金(CMC2022012)
中央级公益性科研院所基本科研业务费专项资金(ZZ15-YQ-016)
国家重点研发计划(2018YFC1707400)
出版年
2024
NETL
NSTL
万方数据