初步构建冻结肩中医临床研究核心结局指标集的思考  

The Reflect on Preliminary Construction of the Core Outcome Index Set of TCM Clinical Research on Frozen Shoulder

作　　者：白杨 陈波[2] 秦懿囡[1,2] 杜元灏 BAi Yang;CHEN Bo;QIN Yinan;DU Yuanhao(The First Affiliated Hospital of Tianjin University of Chinese Medicine,Tianjin China 300073;Tianjin University of Chinese Medicine,Tianjin China 300193;Qingyang Hospital of Chinese Medicine,Qingyang Gansu China 745000)

机构地区：[1]天津中医药大学第一附属医院,天津300073 [2]天津中医药大学,天津300193 [3]庆阳市中医医院,甘肃庆阳745000

出　　处：《中医学报》2021年第1期69-73,共5页Acta Chinese Medicine

基　　金：甘肃省中医药管理局科研课题立项项目(GZK-2018-77)。

摘　　要：冻结肩的中医临床研究中存在报告指标、测量工具、疗效判定标准不一致等诸多问题,造成研究结果不能被系统评价纳入或进行Meta分析,无法提供高级别的证据。而国外建立的冻结肩核心结局指标集不能反映中医临床研究特点,且我国目前也尚未构建适合中医临床研究的冻结肩核心指标集。因此,本研究基于前期中医药核心结局指标集构建方法与实例研究,结合国际肩关节疾病核心指标集的构建经验和方法,拟采用系统评价、半结构化访谈、德尔菲调查和共识会议相结合的方法初步构建冻结肩核心结局指标集和中医核心证候指标集,以适应冻结肩中医临床研究,并初步探索既能够体现中医特色又能够适应临床研究的中医核心指标集的构建流程及方法,为中医临床研究的方案优化和中医临床研究质量的提高提供科学合理的方法学依据。There are many problems in Chinese medicine clinical research of frozen shoulder(FS),such as inconsistent reporting indicators,measurement tools,and judgment criteria.As a result,the research results can not be included in the systematic evaluation or meta-analysis,and can not provide high-level evidence.However,FS core outcome index set established abroad can not reflect the characteristics of clinical research of Chinese medicine,and China has not yet built a core index set of frozen shoulder suitable for clinical research of Chinese medicine.Therefore,based on the construction method and case study of the core outcome index set of Chinese medicine in the early stage,combined with the construction experience and method of international core index set of shoulder joint disease,the method of systematic evaluation,semi-structured interview,Delphi survey and consensus meeting is proposed to initially construct the frozen shoulder core outcome index set and TCM core syndrome index set,so as to adapt to frozen shoulder to provide scientific and reasonable methodological basis for the optimization of TCM clinical research scheme and the quality of TCM clinical research.

关 键 词：冻结肩 核心结局指标集 中医核心证候指标集 中医临床研究 方法学 

分 类 号：R274.981.7[医药卫生—中西医结合]