中华中医药杂志2026，Vol.41Issue(2)：384-387,4.
真实世界视域下中医临床验方人用经验证据转化的评价方法构建探析
Exploration on the construction of evaluation methods for the transformation of human use experience evidence in traditional Chinese medicine clinical prescriptions from the perspective of the real world
摘要
Abstract
Human use experience represents the summation of traditional Chinese medicine(TCM)clinical practice and serves as a vital data source for the application of institutional preparations and the evaluation of efficacy and safety in the development of new TCM drugs.Standardizing the data collection and statistical analysis methods of human use experience in TCM,and establishing efficacy evaluation methods to transform human use experience data into evidence-based data,are essential for converting clinical practice data into research data.This paper attempts to summarize the characteristics of data collection of human use experience evidence in TCM clinical prescriptions and the analysis methods of real-world data.It also provides an overview of how to select clinical research methods that align with the characteristics of TCM clinical practice and how to manage bias risks and confounding factors in standardized data collection and statistical analysis.In response to the TCM-specific diagnostic and therapeutic approach of'formula variation according to syndrome differentiation',a'score-based efficacy evaluation method'is proposed to accurately reflect the therapeutic advantages of human use experience.This method offers a novel approach and perspective for the effectiveness evaluation of transforming human use experience evidence of TCM clinical prescriptions under the perspective of real world.关键词
真实世界研究/中医临床验方/人用经验证据/疗效评价方法Key words
Real-world study/TCM clinical trial formula/Evidence from human use experience/Efficacy evaluation method引用本文复制引用
庾馨予,敖梅英,聂鹤云,张国松,黄浪浪,颜冬梅,管咏梅,刘潜..真实世界视域下中医临床验方人用经验证据转化的评价方法构建探析[J].中华中医药杂志,2026,41(2):384-387,4.基金项目
江西省高校人文社会科学重点研究基地项目(No.JD21101),江西省研究生创新专项资金项目(No.YC2024-B226),江西省全国重点实验室自主部署重点研发计划项目(No.20243BCC31008),国家自然科学基金重点项目(No.82460914) （No.JD21101）
