中医药治疗中风后失语临床研究核心指标集的构建  

Constructing core outcome set for clinical research on traditional Chinese medicine treatment of post-stroke aphasia

作　　者：马亚男 徐敏杰 杨瑜爱 陈健 任巧生 李颖[1] 常静玲[1] MA Ya-nan;XU Min-jie;YANG Yu-ai;CHEN Jian;REN Qiao-sheng;LI Ying;CHANG Jing-ling(Dongzhimen Hospital,Bejing University of Chinese Medicine,Bejing 100700,China;Hohhot Mongolian Medicine of Traditional Chinese Medicine Hospital,Hohhot O10010,China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]呼和浩特市中医蒙医医院,内蒙古呼和浩特010010

出　　处：《中国中药杂志》2025年第1期238-247,共10页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81973790);北京中医药大学东直门医院科技创新专项(DZMKJCX-2022-001)。

摘　　要：该研究基于核心指标集(core outcome set,COS)原理,参考目前国内外构建COS的流程,结合中风后失语疾病特点,构建中医药干预中风后失语有循证证据支持的COS。首先,全面检索四大中文数据库、三大英文数据库及三大临床注册中心,近五年中医药治疗中风后失语的相关文献,进行分析和归纳,形成中医药干预中风后失语临床研究核心结局清单的主要部分。其次,对临床医生及相关护理人员进行访谈,补充临床诊疗过程中认为重要的结局指标,形成核心结局指标条目池。采用2轮德尔菲问卷调查,对条目池中的核心结局指标进行重要性评分。最后,通过专家共识会议建立中医药干预中风后失语临床研究COS。最终纳入268篇研究(236篇RCTs,21篇Meta分析,11篇临床注册方案)和20份开放性问卷调查结果。经过两轮德尔菲专家调查,共14个结局指标及其对应的测量工具进入专家共识会议,最终专家共识会议确定了中风后失语COS,包含9个指标域和12个结局指标。According to the principle and current domestic and international construction processes of core outcome set(COS)and the characteristics of post-stroke aphasia,this study built COS with evidence-based support for traditional Chinese medicine(TCM)treatment of post-stroke aphasia.Firstly,a comprehensive review was conducted on the articles about the TCM treatment of post-stroke aphasia that were published in the four major Chinese databases,three major English databases,and three clinical registration centers over the past five years.The articles were analyzed and summarized,on the basis of which the main part of the COS for clinical research on the TCM treatment of post-stroke aphasia was formed.Secondly,clinical doctors and related nursing personnel were interviewed,and important outcome indicators in the clinical diagnosis and treatment process were supplemented to form a pool of core outcome indicators.Two rounds of Delphi surveys were carried out to score the importance of the core outcome indicators in the pool.Finally,a consensus meeting of experts was held to establish the COS for clinical research on the TCM treatment of post-stroke aphasia.The final COS included a total of 268 studies[236 randomized controlled trials(RCTs),21 Meta-analysis,and 11 clinical registration protocols]and 20 open questionnaire survey results.After two rounds of Delphi surveys,a total of 14 outcome indicators and their corresponding measurement tools were included in the expert consensus meeting.The final expert consensus meeting determined the COS for post-stroke aphasia,which included 9 indicator domains and 12 outcome indicators.

关 键 词：核心指标集 结局指标 中医药 中风后失语 核心指标测量工具 

分 类 号：R255.2[医药卫生—中医内科学]