针刺治疗卒中后吞咽困难随机对照试验结局及其测量工具现状分析  

Analysis on status quo of outcomes and measurement instruments of randomized controlled trials of acupuncture for post-stroke dysphagia

作　　者：曹文聪 邱幸莹 刘冰清 李庚[2,3] 温泽淮[2,3,4] CAO Wen-cong;QIU Xing-ying;LIU Bing-qing;LI Geng;WEN Ze-huai(Second Clinical College,Guangzhou University of CM,Guangzhou 510405,Guangdong Province,China;Key Unit of Methodology in Clinical Research,Guangdong Provincial Hospital of CM,Guangzhou 510120;State Key Laboratory of Dampness Syndrome of CM,Guangdong Provincial Hospital of CM,Guangzhou 510120;National Center for Design Measurement and Evaluation in Clinical Research,Guangzhou University of CM,Guangzhou 510405,Guangdong Province)

机构地区：[1]广州中医药大学第二临床医学院,广东广州510405 [2]广东省中医院临床研究方法学重点研究室,广州510120 [3]广东省中医院省部共建中医湿证国家重点实验室,广州510120 [4]广州中医药大学DME中心,广东广州510405

出　　处：《中国针灸》2023年第9期1086-1093,共8页Chinese Acupuncture & Moxibustion

基　　金：2021年度省部共建中医湿证国家重点实验室重点项目:SZ2021ZZ04。

摘　　要：目的:分析针刺治疗卒中后吞咽困难随机对照试验(RCT)结局及其测量工具的报告情况,为其临床试验设计及构建核心结局指标集提供依据。方法:检索中国期刊全文数据库(CNKI)、中国生物医学文献服务系统(SinoMed)、万方学术期刊全文数据库(Wanfang)、PubMed、EMbase、Web of Science及ClinicalTrials.gov、中国临床试验注册中心(ChiCTR)针刺治疗卒中后吞咽困难的RCT,检索日期为2012年1月1日至2021年10月30日,通过文献筛选和资料提取汇总结局指标及其测量工具并进行整理和分析。结果:共纳入172项研究(165项RCT,7项在研试验注册方案)。涉及91个结局指标,可按照功能属性分为临床表现、理化检查、生活质量、中医症状/证候、远期预后、安全性评价及经济学评估7类指标域。结局指标的选用存在测量工具种类多、差异大、评价时点不统一及报告不分主次等问题。结论:针刺治疗卒中后吞咽困难RCT结局及其测量工具现状不利于各个试验结果的汇总和比较。建议构建该类临床研究的核心结局指标集,以提高其临床试验设计的规范性和研究质量。Objective To analyze the report status of outcomes and measurement instruments of randomized controlled trials(RCTs)of acupuncture for post-stroke dysphagia,so as to provide a basis for designing clinical trials and developing the core outcome set in acupuncture for post-stroke dysphagia.Methods RCTs of acupuncture for post-stroke dysphagia were searched in databases i.e.CNKI,SinoMed,Wanfang,PubMed,EMbase,Web of Science and clinical trial registries i.e.ClinicalTrials.gov and Chinese Clinical Trial Registry(ChiCTR),from January 1st,2012 to October 30th,2021.By literature screening and data extraction,outcomes and measurement instruments were summarized and analyzed.Results A total of 172 trials(including 165 RCTs and 7 ongoing trials registrations)were included,involving 91 outcomes.The outcomes could be classified into 7 domains according to functional attributes,namely clinical manifestation,physical and chemical examination,quality of life,TCM symptoms/syndromes,long-term prognosis,safety assessment and economic evaluation.It was found that there were various measurements instruments with large differences,inconsistent measurement time point and without discriminatively reporting primary or secondary outcomes.Conclusion The status quo of outcomes and measurement instruments of RCTs of acupuncture for post-stroke dysphagia is not conducive to the summary and comparison of each trial's results.Thus,it is suggested to develop a core outcome set for acupuncture for post-stroke dysphagia to improve the normative and research quality of their clinical trial design.

关 键 词：卒中 吞咽困难 针刺 随机对照试验 核心结局指标 

分 类 号：R245[医药卫生—针灸推拿学]