中医药临床试验核心指标集研制技术规范  

Technical procedures standard for developing core outcome sets for clinical trials of traditional Chinese medicine

作　　者：张明妍 张俊华 张伯礼 李幼平 杜亮[2,3] 张永刚 胡镜清[4] 谢雁鸣 高蕊[5] 杨忠奇[6] 唐健元[7] 胡思源[8] 张磊[9] 田金徽 元唯安[11] 申春悌[12] 王保和[13] 黄宇虹[13] 朱明军[14] 郑文科[1,2] 钟成梁[8] 邢冬梅[14] 李雪梅 杨丰文[1,2] 王辉[1,2] 刘春香 张冬 ZHANG Ming-yan;ZHANG Jun-hua;ZHANG Bo-li;LI You-ping;DU Liang;ZHANG Yong-gang;HU Jing-qing;XIE Yan-ming;GAO Rui;YANG Zhong-qi;TANG Jian-yuan;HU Si-yuan;ZHANG Lei;TIAN Jin-hui;YUAN Wei-an;SHEN Chun-ti;WANG Bao-he;HUANG Yu-hong;ZHU Ming-jun;ZHENG Wen-ke;ZHONG Cheng-liang;XING Dong-mei;LI Xue-mei;YANG Feng-wen;WANG Hui;LIU Chun-xiang;ZHANG Dong(Evidence-based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Chinese Clinical Trial Core Outcome Set Research Center,Tianjin 301617,China;The Chinese Centre of Evidence-based Medicine,WestChina Hospital of Sichuan University,Chengdu 610041,China;China Academy of Chinese Medical Sciences,Beijing 100700,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;The First Affiliated Hospital ofGuangzhou University of Chinese Medicine,Guangzhou 510000,China;Affiliated Hospital of Chengdu University of TCM,Chengdu 610075,China;The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300201,China;Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Center for Evidence-Based Medicine,Lanzhou University,Lanzhou 730000,China;National Drug Clinical Trial Institution,Shuguang Hospital Afiliated to ShanghaiUniversity of Traditional Chinese Medicine,Shanghai 201203,China;Changzhou Hospital Affiliated to Nanjing Universityof Chinese Medicine,Changzhou 213000,China;The Second Affiliated Hospital of Tianjin University of Traditional ChineseMedicine,Tianjin 300150,China;The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China;Baokang Hospital,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China)

机构地区：[1]天津中医药大学循证医学中心,天津301617 [2]中国临床试验核心指标集研究中心,天津301617 [3]四川大学华西医院中国循证医学中心,成都610041 [4]中国中医科学院,北京100700 [5]中国中医科学院西苑医院,北京100091 [6]广州中医药大学第一附属医院,广州510000 [7]成都中医药大学附属医院,成都610075 [8]天津中医药大学第一附属医院,天津300201 [9]上海中医药大学,上海201203 [10]兰州大学循证医学中心,兰州730000 [11]上海中医药大学附属曙光医院国家药物临床试验机构,上海201203 [12]南京中医药大学附属常州市中医医院,常州213000 [13]天津中医药大学第二附属医院,天津300150 [14]河南中医药大学第一附属医院,郑州450000 [15]天津中医药大学附属保康医院,天津300193

出　　处：《中华中医药杂志》2021年第2期924-928,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家自然科学基金项目(No.81473544,No.81904056)。

摘　　要：研制核心指标集是解决中医药临床试验疗效评价指标不一致、不规范、不公认、随意性等问题的重要途径。为了引导各个专科病种能规范、高效地建立中医临床试验核心结局指标,进一步提升中医临床研究的质量,需要建立中医药临床研究核心指标集研制规范。本课题组结合中医特点和国际核心指标集最新研究成果,构建了结局指标条目产生方法、指标域确定方法、核心指标条目遴选方法、核心指标一致性认定方法等。该技术规范已通过中华中医药学会的审核发布(编号T/CACM 1339—2020)。Developing a core outcome set(COS)is an important way to solve the problems of inconsistency,nonstandard,not recognized,arbitrariness on outcome measures in the efficacy evaluation of clinical trials of traditional Chinese medicine(TCM).In order to guide various specialty diseases to establish COS-TCM in a standardized and efficient manner,and further improve the quality of clinical researches on traditional Chinese medicine,it is necessary to establish the standard technical procedures for developing COS-TCM.Combining the characteristics of traditional Chinese medicine and the latest research results of the international core outcome set,we developed a set of standards and methodology,including outcome items generation methods,outcome domain determination method,core outcome items selection method,core outcome consistency determination method.This technical procedure has been approved by China Association of Chinese Medicine which is numbered T/CACM 1339-2020.

关 键 词：标准 核心指标集 中医药 临床试验 技术规范 循证医学 结局指标 

分 类 号：R2-03[医药卫生—中医学]