个体化诊疗视角下中医药临床疗效评价体系的优化方法探讨  

Discussion on Innovative Methods of the Clinical Efficacy Evaluation System for Traditional Chinese Medicine in the Context of Personalized Medicine

作　　者：邱馨锐 冷祥杰 赖新梅[1] 杨朝阳[1] 方积乾[3] 李灿东[1] QIU Xinrui;LENG Xiangjie;LAI Xinmei;YANG Zhaoyang;FANG Jiqian;LI Candong(Base for Research on Traditional Chinese Medicine Syndromes,Fujian University of Traditional Chinese Medicine,Fuzhou,350122;College of Ophthalmology,Chengdu University of Traditional Chinese Medicine;School of Public Health,Sun Yat-sen University)

机构地区：[1]福建中医药大学中医证研究基地,福建省福州市350122 [2]成都中医药大学眼科学院 [3]中山大学公共卫生学院

出　　处：《中医杂志》2024年第23期2389-2393,共5页Journal of Traditional Chinese Medicine

基　　金：国家重点研发计划(2023YFC3503000);福建省自然科学基金(2022J01872)。

摘　　要：个体化诊疗强调个性化及动态化的治疗决策,因此迫切需要适应这种模式的新型疗效评价体系。通过回顾以往临床研究实践,指出在个体化诊疗视角下,中医药临床疗效评价体系在伦理审查、试验设计、数据管理和统计分析等方面面临新的需求,并以传统中医辨证论治的评价为例,围绕这些需求提出一套以亚群化动静态平行组设计与分析为主要方法,以持续审查、动态知情同意及多中心伦理审查体系为保障机制,以个体化临床疗效评价与证据支持一体化平台为技术支撑,以融合贝叶斯与传统统计方法的统计策略为基础的疗效评价体系方法,旨在促进中医个体化诊疗的发展。Personalized medicine emphasizes individualized and dynamic treatment decisions.There is an urgent need for a new efficacy evaluation system that can adapt to this approach.By reviewing past clinical research practices,this article pointed out the innovative needs of traditional Chinese medicine(TCM)efficacy evaluation from the per⁃spective of personalized medicine in terms of ethical review,trial design,data management,and statistical analysis.Focusing on these needs,the article has proposed a strategic framework using syndrome differentiation and treatment in TCM as an example.The framework includes a method based on subgroup dynamic-static parallel group design and analysis,a safeguard mechanism of continuous review,dynamic informed consent,and multicenter ethical review,a technological support platform for personalized clinical efficacy evaluation and evidence support,and a statistical strategy integrating Bayesian and traditional analysis methods,aiming to promote the development of personalized TCM diagnosis and treatment.

关 键 词：临床疗效评价 个体化诊疗 中医药 伦理审查 试验设计 数据管理 统计分析 

分 类 号：R24[医药卫生—中医临床基础]