针灸治疗慢性非特异性腰痛随机对照试验结局指标的现状研究  

Outcome Measures Used in Randomized Controlled Trials of Acupuncture for Chronic Nonspecific Low Back Pain

作　　者：林蕙泽 闫文茜 张萍萍 费静雯 申江红 柳兰萍 王翔 朱可欣 杨涛[1] 于金娜[1] LIN Huize;YAN Wenxi;ZHANG Pingping;FEI Jingwen;SHEN Jianghong;LIU Lanping;WANG Xiang;ZHU Kexin;YANG Tao;YU Jinna(Department of Acupuncture,Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China)

机构地区：[1]中国中医科学院广安门医院针灸科,北京市100053

出　　处：《中国全科医学》2023年第9期1053-1063,共11页Chinese General Practice

基　　金：国家重点研发计划项目(2019YFC171200)。

摘　　要：背景针灸是治疗慢性非特异性腰痛(CNSLBP)的重要方法。随着研究的发展,大量针灸治疗CNSLBP的随机对照试验(RCT)已经发表,但由于在结局指标选择方面存在一定的问题,严重限制了高质量临床证据的产生。目的评价针灸治疗CNSLBP RCT选用的结局指标情况,为针灸治疗CNSLBP相关研究提供参考依据。方法系统检索4个中文数据库(中国知网、维普网、万方数据知识服务平台、中国生物医学文献服务系统)、3个英文数据库(PubMed、Embase、Cochrane Library)2017-01-01至2022-03-15发布的针灸治疗CNSLBP的文献,以及自建库以来至2022-03-15发表的非特异性腰痛(NSLBP)的核心结局指标集(COS)。对纳入的针灸治疗CNSLBP的文献基本特征进行分析,对文献的临床结局指标进行归类,对文献中的结局指标及《中医病证诊断疗效标准》的应用现状进行分析。分析NSLBP研究的COS现状,比较其与现有针灸治疗CNSLBP文献结局指标的异同。结果本研究纳入的针灸治疗CNSLBP的49篇文献均为RCT,共包含4篇英文文献和45篇中文文献。共包含4272例患者,其中观察组2049例、对照组2223例,年龄为18~69岁。38篇文献报告了病程。纳入的文献共包含33个结局指标,分为疼痛类指标、功能障碍指标、复合指标、生活质量指标、日常生活能力指标、安全性指标、患者满意度指标、疾病认知指标、心理状态指标、其他指标。单篇文献的结局指标数量为1~8个。42篇文献的结局指标测量时点为治疗前和治疗后2个时点。仅有2篇文献报告了安全性指标。《中医病证诊断疗效标准》中“有效率”指标的使用率为77.55%(38/49)。11篇NSLBP研究的COS的指标域涵盖了疼痛类指标、功能障碍指标、生活质量指标、心理状态指标、社会功能指标和患者满意度指标等,其中3篇文献对指标域重要性进行了分级,4篇文献涵盖了患者满意度指标,5篇文献涵盖了心�Background As an important treatment for chronic nonspecific low back pain(CNSLBP),the effect of acupuncture on CNSLBP has been studied by numerous randomized controlled trials(RCTs)with the development of research on acupuncture.However,there are some problems in the selection of outcome indicators,which severely hinder the generation of high-quality clinical evidence.Objective To describe the outcome measures used in RCTs of acupuncture for CNSLBP,providing a basis for the carrying out of relevant research.Methods Four Chinese databases(CNKI,VIP,Wanfang Data and SinoMed)and three English databases(PubMed,Embase and Cochrane Library)were systematically searched for literature on CNSLBP treated with acupuncture published from January 1,2017 to March 15,2022,and the NSLBP core outcome set(COS)used in studies published from database inception to March 15,2022.According to the enrolment criteria to analyze the following aspects:basic characteristics,classification of clinical outcome indicators,use of composite indicators,and the application of TCM Criteria for Diagnosis and Treatment of Diseases&Syndromes(hereinafter referred to as TCMCDTDS).In addition,11 studies published from database inception to March 15,2022 were enrolled to analyze their basic characteristics and use of COSs of NSLBP.In addition,to analyze the studies’basic characteristics and use of NSLBP COS.The similarities and differences between COSs of NSLBP and outcome measures in the RCTs in recent five years were compared.Results Of the included 49 RCTs,four are in English and the other 45 are in Chinese,involving 4272 cases aged from 18 to 69 years(2049 in the treatment group,and 2223 in the control group).The course of CNSLBP was reported in 38 RCTs.A total of 33 outcome indicators were used in all the RCTs,divided into assessing pain,dysfunction,quality of life,activities of daily living,treatment safety,patient satisfaction,disease recognition,psychological status indicators,and other indicators.The outcome indicator number in one RCT were fro

关 键 词：针灸疗法 腰痛 慢性非特异性腰痛 随机对照试验 结局指标集 结局指标 

分 类 号：R681.55[医药卫生—骨科学]