中医临床疗效评价核心指标遴选的关键问题及解决途径  

Key issues and solutions in the selection of core outcomes in clinical efficacy evaluation for traditional Chinese medicine

作　　者：邱瑞瑾[1,2] 关之玥 张心怡 陈卓 王文惠 商洪才 QIU Ruijin;GUAN Zhiyue;ZHANG Xinyi;CHEN Zhuo;WANG Wenhui;SHANG Hongcai(Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing,Dongzhimen Hospital,Beijing University of Traditional Chinese Medicine,Beijing 100029,P.R.China;University of Liverpool,Liverpool L693GL,UK;Hunan University of Traditional Chinese Medicine,Changsha 410208,P.R.China)

机构地区：[1]北京中医药大学东直门医院中医内科学教育部和北京市重点实验室,北京100700 [2]英国利物浦大学,英国利物浦L693GL [3]湖南中医药大学,长沙410208

出　　处：《中国循证医学杂志》2024年第4期466-471,共6页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金项目(编号:82274354)。

摘　　要：中医临床研究中结局指标遴选存在诸多问题,如结局指标的适用性研究不足、辨证论治个体化指标体现不充分、整体/综合评价指标选择方法不完善、结局指标重要性判断缺乏证据支持、结局指标的人文价值体现不明显等。虽然核心指标集可以一定程度上帮助临床研究者选择结局指标,但其目前并未被临床研究者广泛应用,且核心指标集中结局指标重要性的判断主要基于参与者的个人经验,缺少方法学的支持,也会导致同一疾病有多个核心指标集,造成浪费。笔者认为,需要不断完善结局指标研究的方法学,特别是在核心指标集研究中,可通过构建证据和人文价值理念指导下的中医临床疗效评价核心指标遴选框架来解决这些问题。There are many problems in the selection of outcomes in clinical trials of traditional Chinese medicine(TCM),such as insufficient research on the applicability of outcomes,insufficient research of individualized outcomes for syndrome differentiation and treatment,incomplete selection methods for overall/comprehensive evaluation outcomes,lack of evidence in the importance of outcomes for researchers,and insufficient reflection of the humanistic value of outcomes.Although the core outcome sets(COS)may help clinical trialists to select outcomes to a certain extent,the COS has not been widely used at present,and the judgment of the importance of the outcomes in the COS is mainly based on the personal experience of the participants.The lack of methodology will also lead to multiple COS in the same disease area.The authors believe that it is necessary to improve the methodology of outcomes research,especially in the development of COS.Developing evidence and humanistic values framework may be a potential way to help researchers select core outcomes in clinical efficacy evaluation of TCM.

关 键 词：疗效评价 结局指标 证据 人文价值 方法学 

分 类 号：R2-0[医药卫生—中医学]