中医临床试验证据个体适用性评价方法的探索构建  

Exploration and establishment of individual applicability evaluation method on traditional Chinese medicine clinical trials

作　　者：魏旭煦 关曼柯 石兆峰 尤良震 蒋寅 赵晨 商洪才[1,3] WEI Xuxu;GUAN Manke;SHI Zhaofeng;YOU Liangzhen;JIANG Yin;ZHAO Chen;SHANG Hongcai(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,P.R.China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,P.R.China;International Evidence-Based Chinese Medicine Institute,Beijing University of Chinese Medicine,Beijing 100029,P.R.China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]中国中医科学院中医临床基础医学研究所,北京100700 [3]北京中医药大学国际循证中医药研究院,北京100029

出　　处：《中国循证医学杂志》2021年第7期858-862,共5页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金项目(编号:81725024、81803963)。

摘　　要：在循证实践的路径中,证据的个体适用性评价依赖于临床医生的主观判断,缺少系统的方法学指导。而中医临床信息的复杂性增加了依靠主观判断证据适用性的不确定性和风险。本文分析循证临床实践流程,对中医药证据适用性评价的方法学进行了探索和尝试,提出通过建立基于临床试验原始数据的疗效预测模型来评价证据的个体适用性,以促进中医药证据的合理应用。In the process of evidence-based practice,the evaluation of evidence applicability relied on the subjective judgment of clinicians,while the systematic method of which was still in lack.The complex clinical information of traditional Chinese medicine(TCM)enhanced the uncertainty and risk of applying evidence.Based on the analysis of the process of evidence-based practice,this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients.The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.

关 键 词：中医药 临床试验 证据适用性 个体化 原始数据 

分 类 号：R288[医药卫生—中药学]