手法治疗膝骨关节炎随机对照试验的结局指标现状分析  

Analysis on the Current Status of Outcome Indicators in Randomized Controlled Trials of Manual Treatment for Knee Osteoarthritis

作　　者：顾金光 魏光成 赵勇[1] 董永丽[1] 卓泽川 侯成志 秦伟凯[1] GU Jinguang;WEI Guangcheng;ZHAO Yong;DONG Yongli;ZHUO Zechuan;HOU Chengzhi;QIN Weikai(Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102,China;Suzhou Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine,Suzhou 215009,China)

机构地区：[1]中国中医科学院望京医院,北京100102 [2]南京中医药大学附属苏州市中医医院,江苏苏州215009

出　　处：《中国中医药信息杂志》2025年第4期58-64,共7页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：中国中医科学院科技创新工程(CI2021A03604);中国中医科学院望京医院高水平中医医院建设项目“名老医药专家学术经验传承”(WJCC-202316)。

摘　　要：目的通过分析手法治疗膝骨关节炎(KOA)的随机对照试验(RCT)结局指标的使用现状,为手法治疗KOA的临床疗效评价方法提供意见。方法系统检索中国知网(CNKI)、万方数据知识服务平台、中文科技期刊数据库(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane Library、Scopus、Web of Science手法治疗KOA的RCT研究,检索时间2014年3月-2024年3月。由2名研究者筛查文献,提取文献特征,并分析手法治疗KOA的RCT指标域、测量工具、测量时点。结果纳入文献134篇,样本量17659例,涉及结局指标138个,对结局指标进行分类,其中症状/体征64项(46.4%)、理化检查54项(39.1%)、生活质量11项(8.0%)、心理状态指标2项(1.4%)、安全性指标2项(1.4%)、肌力测试2项(1.4%)、其他3项(2.2%)。134篇文献包含36个测量时间点,研究时间跨度为治疗后1 h至1年;91篇(67.9%)文献使用了“临床疗效”作为结局指标;27篇(20.1%)文献报告了不良事件并进行了安全性评价。结论手法治疗KOA的RCT结局指标存在缺乏代表性、整体性、客观性和特色性等问题,应从代表性、整体性、客观性和特色性方面提升结局指标的严谨性,以期对疾病研究起到完整的评估效果。Objective To provide suggestions for the clinical efficacy evaluation method of manual therapy for knee osteoarthritis(KOA)by analyzing the current status of the use of outcome indicators in randomized controlled trials(RCTs)of manual therapy for KOA.Methods RCTs about manual treatment of KOA were retrieved from CNKI,Wanfang Data,VIP,SinoMed,PubMed,Cochrane Library,Scopus and Web of Science from March 2014 to March 2024.Two researchers screened literature,extracted literature features,analyzed the RCT indicator domain,measurement tools,and measurement time points for manual treatment of KOA.Results A total of 134 articles were included,with a sample size of 17659.A total of 138 outcome indicators were used to classify the outcome indicators:64 symptoms and signs(46.4%),54 physical and chemical examinations(39.1%),11 quality of life(8.0%),2 psychological status indicators(1.4%),2 safety indicators(1.4%),2 muscle strength testing indicators(1.4%)and 3 other indicators(2.2%).Among 134 articles,there were a total of 36 measurement time points,with a research time span of 1 hour to 1 year after treatment;91 articles(67.9%)used“clinical efficacy”as the outcome measure;27 articles(20.1%)were evaluated for safety and reported adverse events.Conclusion The RCT outcome indicators of manual therapy for KOA lack representativeness,integrality,objectivity and specificity.The rigorism of the outcome indicators should be improved from the aspects of representativeness,integrality,objectivity and specificity,in order to achieve a complete evaluation effect on disease research.

关 键 词：膝骨关节炎 推拿 随机对照试验 结局指标 

分 类 号：R274.94[医药卫生—中西医结合]