中医证候疗效评价量表研制指南  

Guideline on establishing traditional Chinese medicinesyndrome efficacy evaluation scale

作　　者：王建新 孙明月[1] 吕行 郭曼萍 代欣玥 杨巧宁[1] 申春悌[4] 元唯安[5] 王天芳[6] 连凤梅[7] 刘树林[8] 张磊[9] 谢雁鸣[10] 王忠[10] 王保和[11] 黄宇虹[12] 刘文娜[13] 高蕊[1,3] WANG Jian-xin;SUN Ming-yue;LV Xing;GUO Man-ping;DAI Xin-yue;YANG Qiao-ning;SHEN Chun-di;YUAN Wei-an;WANG Tian-fang;LIAN Feng-mei;LIU Shu-lin;ZHANG Lei;XIE Yan-ming;WANG Zhong;WANG Bao-he;HUANG Yu-hong;LIU Wen-na;GAO Rui(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Center for Post-doctoral Studies,China Academy of Chinese Medical Sciences,Beijing 100700,China;NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine,Beijing 100091,China;Nanjing University of Chinese Medicine,Nanjing 210023,China;Shuguang Hospital,Shanghai University of Chinese Medicine,Shanghai 201203,China;Beijing University of Chinese Medicine,Beijing 100029,China;Guanganmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China;Shanghai University of Chinese Medicine,Shanghai 201203,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100091,China;First Affiliated Hospital of Tianjin University of Chinese Medicine,Tianjin 300073,China;Second Affiliated Hospital of Tianjin University of Chinese Medicine,Tianjin 300150,China;Dongfang Hospital of Beijing University of Chinese Medicine,Beijing 100078,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 [4]南京中医药大学,南京210023 [5]上海中医药大学曙光医院,上海201203 [6]北京中医药大学,北京100029 [7]中国中医科学院广安门医院,北京100053 [8]广州中医药大学第一附属医院,广州510405 [9]上海中医药大学,上海201203 [10]中国中医科学院中医临床基础研究所,北京100091 [11]天津中医药大学第一附属医院,天津300073 [12]天津中医药大学第二附属医院,天津300150 [13]北京中医药大学东方医院,北京100078

出　　处：《中国新药杂志》2025年第2期113-122,共10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《中医临床疗效评价指标体系研究》项目(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：量表是实现传统证候主观定性指标量化、客观化评价的重要工具。证候疗效评价量表可为证候疗效评价提供客观公认的研究证据,是构建符合中医药特色的中医临床疗效评价指标体系的重要内容。目前行业内尚无统一的证候疗效评价量表构建方法与共识。本研究总结前期已研制的中医证候疗效评价量表技术规范与流程,起草了《中医证候疗效评价量表研制指南》。本指南进一步明确并规范了以“证候相关核心症状/体征”为主体的中医证候疗效评价量表构建的关键技术与流程,为中西医临床医师、中医药临床研究工作者、中药研发相关人员及企业开展中医证候疗效评价提供方法学指导,实现中医证候疗效评价的科学化、客观量化与标准化,为开展中医药临床疗效评价、证候类中药新药研发提供参考。Scale is an important tool to realize the quantitative and objective evaluation of subjective qualitative indicators of traditional Chinese medicine(TCM)syndrome.The TCM syndrome efficacy evaluation scale can provide objective and recognized research evidence for the evaluation of syndrome efficacy and is an important part of constructing the evaluation indicator system of efficacy in line with the characteristics of TCM.There were no unified methods and consensus for the construction of syndrome efficacy evaluation scale.This study summarized the technical specifications and processes of the TCM syndrome efficacy evaluation scale developed previously and drafted the guideline on establishing TCM syndrome efficacy evaluation scale.This guideline clarifies and standardizes the key technologies and processes for the construction of TCM syndrome efficacy evaluation scale with“syndrome-related core symptoms/signs”as the main body,provides methodological guidance for TCM and Western medicine clinicians and clinical researchers to carry out evaluation of the syndrome efficacy of TCM,realizes the scientific,objective quantification and standardization evaluation of the efficacy of TCM syndrome,and serves the clinical efficacy evaluation and the research of new drugs of syndrome type.

关 键 词：证候疗效 量表 指南 

分 类 号：R969.4[医药卫生—药理学]