基于中医辨证论治与整体观的临床研究治疗效果异质性探析OA
Analysis on Heterogeneity in Clinical Research Treatment Effects Based on TCM Syndrome Differentiation and Treatment and Holistic View
治疗效果异质性是临床研究中的固有性质,传统的随机对照试验通常是通过对比2组人群的边际平均值评估其疗效,难以全面反映各亚组人群的真实疗效,影响药物研发进程.本文针对治疗效果异质性探究测量及评估方法,基于中医辨证论治对治疗效果异质性进行多维探讨,从提高研究设计的严谨性与针对性、优化中医临床研究结局评价体系、加强中医标准化建设与基础研究、优化中医临床研究中数据分析方法4个方面探索中医临床研究治疗效果异质性的处理方法,为临床研究中快速、精准识别并处理治疗效果异质性提供参考.
Heterogeneity of treatment effect is an inherent characteristic in clinical research.Traditional randomized controlled trials usually evaluate therapeutic efficacy by comparing the marginal means between two groups,which fails to fully reflect the true efficacy across different subgroups and hinders the process of drug development.This article explored methods for measuring and evaluating heterogeneity of treatment effect,and provided a multi-dimensional discussion based on TCM syndrome differentiation and treatment.It proposed strategies for managing heterogeneity of treatment effect in TCM clinical research from four aspects:improving the rigor and specificity of study design,optimizing the outcome evaluation system for TCM clinical studies,strengthening TCM standardization and basic research,and refining data analysis methods in TCM clinical study.This article aimed to provide a reference for rapid and accurate identification and management of heterogeneity of treatment effect in clinical research.
钱真真;张国瑗;代欣玥;于亚南;武红莉;赵阳;高蕊;荆志伟;鲁喦
中国北京同仁堂(集团)有限责任公司,北京 100061||中国中医科学院西苑医院,北京 100091||中国中医科学院博士后流动站,北京 100700中国中医科学院西苑医院,北京 100091||中国中医科学院博士后流动站,北京 100700中国中医科学院西苑医院,北京 100091||中国中医科学院博士后流动站,北京 100700||华润三九医药股份有限公司,广东 深圳 518110中国中医科学院临床基础医学研究所,北京 100700中国中医科学院临床基础医学研究所,北京 100700中国中医科学院西苑医院,北京 100091中国中医科学院西苑医院,北京 100091中国中医科学院临床基础医学研究所,北京 100700中国北京同仁堂(集团)有限责任公司,北京 100061||北京同仁堂股份有限公司科学研究所,北京 100011
医药卫生
治疗效果异质性异质性分析临床试验评估测量
heterogeneity of treatment effectheterogeneity analysisclinical trialevaluation and measurement
《中国中医药信息杂志》 2026 (8)
1-5,5
国家自然科学基金(82074584)国家科技重大专项(2024ZD0532600)
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