近5年针刺治疗中风后痉挛性偏瘫随机对照试验结局指标的现存问题分析  

Analysis of Existing Problems about Outcome Indicators in Randomized Controlled Trials of Acupuncture Treating Post-Stroke Spastic Hemiplegia in Last Five Years

作　　者：秦文秀 许军峰[1,2] 高莹 杨婷[1,2,3] 王坪霏 陈海霞 杜健强 QIN Wenxiu;XU Junfeng;GAO Ying;YANG Ting;WANG Pingfei;CHEN Haixia;DU Jianqiang(The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China;Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Gansu University of Chinese Medicine,Lanzhou 730000,China)

机构地区：[1]天津中医药大学第一附属医院,天津300381 [2]国家中医针灸临床医学研究中心,天津300381 [3]天津中医药大学,天津301617 [4]甘肃中医药大学,甘肃兰州730000

出　　处：《针灸临床杂志》2023年第12期42-50,共9页Journal of Clinical Acupuncture and Moxibustion

基　　金：国家自然科学基金,编号:82104998;天津市教委科研计划项目,编号:2022ZD045。

摘　　要：目的:分析针刺治疗中风后痉挛性偏瘫随机对照试验(RCTs)的结局指标应用现状,为针刺治疗中风后痉挛性偏瘫核心结局指标集的研究提供基础。方法:全面检索PubMed、Web of Science、Cochrane Library、CBM和中国知网数据库(CNKI)、万方数据知识服务平台(Wanfang)、维普中文科技期刊数据库(VIP)与中国临床试验注册中心中针刺治疗中风后痉挛性偏瘫的RCTs,检索时间范围均从2018年1月—2023年1月。使用Cochrane风险偏倚评估工具对纳入的研究进行质量评价,采用定性分析的方法描述纳入研究的结局指标。结果:初步检索纳入相关文献1027篇,最终纳入44篇文献(中文文献43篇,英文文献1篇),共报告了50个结局指标,使用频次为203次,其中症状体征使用频次最高,理化检测次之。结论:针刺治疗中风后痉挛性偏瘫的RCT结局指标现存在命名、参考标准及测量时点不统一、使用频次不均衡、主次结局指标不明确和偏倚风险模糊等问题,国内学者理应参考国际经验,结合针刺的临床研究特点构建规范、统一的核心指标结局指标集。Objective:To analyze the application status of outcome indicators in randomized controlled trials(RCTs)of acupuncture treating post-stroke spastic hemiplegia.Methods:A comprehensive search of PubMed,Web of Science,Cochrane Library,CBM,CNKI,Wanfang and VIP,and RCTs of acupuncture for post-stroke spastic hemiplegia in the Chinese Clinical Trials Registry were conducted,and the retrieve period was from January 2018 to January 2023.The quality of the included studies was evaluated by using the Cochrane Risk Bias Assessment Tool,and the outcome indicators of the included studies were described by using the qualitative analysis.Results:The preliminary search was included in the relevant literature of 1027 articles,44 articles were finally included(43 Chinese articles,1 English article),and a total of 50 outcome indicators were reported.The frequency of use was 203 times,among which the application times of symptoms and signs were on the top,followed by physical and chemical testing.Conclusion:The RCTs outcome indicators of post-stroke spastic hemiplegia treated by acupuncture have problems,including non-uniform naming,disagreement on reference standards and time points of measurement,uneven frequency of use,unclear primary and secondary outcome indicators,and ambiguous risk of bias.It is reasonable for domestic scholars to refer to international experience and combine the clinical research characteristics of acupuncture to construct a standardized and unified set of core indicators of outcome indicators.

关 键 词：针刺 中风 痉挛性偏瘫 随机对照试验 结局指标 

分 类 号：R246.6[医药卫生—针灸推拿学]