中医证候疗效评价指标体系的构建与思考  

Construction and considerations on efficacy evaluation indicator system of Chinese medicine syndrome

作　　者：王建新 代欣玥 孙明月[1] 吕行 郭曼萍 訾明杰[1] 杨巧宁[1] 高蕊[1,3] WANG Jian-xin;DAI Xin-yue;SUN Ming-yue;LV Xing;GUO Man-ping;ZI Ming-jie;YANG Qiao-ning;GAO Rui(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Postdoctoral Research Station of China Academy of Chinese Medical Sciences,Beijing 100700,China;National Medical Products Administration for Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine,Beijing 100091,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]中国中医科学院博士后流动站,北京100700 [3]国家药品监督管理局中药临床研究与评价重点实验室,北京100091

出　　处：《中国新药杂志》2025年第4期341-345,共5页Chinese Journal of New Drugs

基　　金：国家中医药管理局中医药科学技术研究专项资助项目(GZY-KJS-2021-019);中华中医药学会资助项目“中医临床疗效评价指标体系研究”(CACMRE2023-A-02);中国中医科学院科技创新工程重大攻关项目(CI2021A04701);中国中医科学院科技创新工程-中药临床药理学培育项目(CI2021A04708)。

摘　　要：基于“疾病变化、证候特征、人体健康生命状态三要素结合”构建评价指标体系,遵循主客观指标结合、医患共评相结合、病证结合、定性与定量研究方法相结合的原则,实现多指标、多维度、系统性综合评价中医药临床疗效的目标。中医证候疗效是中医特有且最能体现中医药优势的疗效评价指标,但其科学内涵、评价思路与方法、关键技术尚不明确,导致中医证候疗效评价模式与方法多样,评价指标各不相同,限制了中医临床疗效评价指标体系的构建。本研究阐明多层次、多维度、多角度证候疗效评价的科学内涵,明确了基于医生报告结局、患者报告结局的中医证候相关症状或体征指标以及证候相关客观生物学指标的评价维度,提出基于医生用和患者用证候疗效评价量表以及客观生物学指标评价证候疗效,构建了中医临床有效性疗效评价指标体系结构,以期实现中医证候疗效评价科学化、客观量化和标准规范化,实现多指标、多维度系统评价中医临床疗效。Based on the construction of the three-dimensional efficacy evaluation index system of“disease-syndrome-person”,following the principle of combining subjective and objective indicators,doctor and patient reported outcomes,disease of Western medicine and syndrome of traditional Chinese medicine(TCM),and qualitative and quantitative research methods,this study aimed to achieve the goal of multi-index,multi-dimensional and comprehensive evaluation of clinical efficacy of TCM.The efficacy of TCM syndrome is conspicuously characteristic and the best example of efficacy evaluation indicators of TCM.However,the uncertainty of scientific connotation,evaluation ideas and methods,and key technologies of the efficacy of TCM syndrome results in confusion and heterogeneity of evaluation indicators,thus limiting the construction of efficacy evaluation indicator system of TCM.This study elucidated the multi-level,multi-dimensional and multi-perspective scientific connotation,clarified the evaluative dimension of patient and doctor-reported outcome indicators and objective biological indicators,advised using syndrome efficacy evaluation scales to evaluate the efficacy of Chinese medicine syndrome,and established the structure of the evaluation indicator system of TCM,to achieve scientific,objective,quantitative and standard evaluation of the efficacy of TCM syndrome and evaluating the efficacy of TCM with a multi-index and multi-dimension system.

关 键 词：证候疗效 评价指标 综合评价 

分 类 号：R95[医药卫生—药学]