摘要
目的:分析传统功法治疗膝骨关节炎(knee osteoarthritis,KOA)临床随机对照试验(randomized controlled trial,RCT)的现状。方法:计算机检索中国知网、万方数据库、维普网、中国生物医学文献服务系统、PubMed、Embase、Web of Science、Cochrane Library中传统功法治疗KOA的RCT文献,检索时限为各数据库建库至2025年2月。对检索所得的文献进行筛选后,提取文献中RCT研究的基本特征信息和结局指标信息,并对提取的信息进行分析。结果:①文献检索及筛选结果。初步检索出相关文献2412篇,经逐层筛选后最终纳入文献67篇,包括中文文献25篇、英文文献42篇。②纳入研究的基本特征分析结果。纳入的67项研究的发表时间集中在2003—2024年;样本量<60例21项,60~99例29项,100~200例12项,>200例5项;均报告了疾病的西医诊断标准,其中有5项研究报告了中医证型诊断标准;41项研究的试验组干预措施为单纯传统功法治疗,26项研究的试验组干预措施为传统功法联合其他疗法;共出现5种传统功法,出现频次由高至低依次为太极拳、八段锦、易筋经、气功、五禽戏;干预疗程和随访时间均以12周居多。③纳入研究的结局指标分析结果。45项研究的结局指标评价时间点为干预前和干预结束后2个时间点,21项研究的结局指标评价时间点为干预前、干预过程中和干预结束后3个时间点。26项研究区分了主、次要结局指标,采用行业现有评价标准,其中1项研究对主、次要结局指标采用了不同的评价时间点;41项未区分主、次要结局指标,均采用自定义评价标准。每项研究选取的结局指标数为1~13个。共涉及结局指标86项,可划分为7个指标域,包括症状/体征指标28项、生活质量指标20项、理化指标15项、影像和生物力学指标12项、其他指标6项、安全性指标4项和远期疗效指标1项;出现频次较高的结局指标由高至低依次为西安大略和麦克马斯特大学骨关节炎指数疼痛评分(47次)、功能评分(46次)、僵硬评分(43次),以及平衡能力/本体感觉测试(33次)和疼痛视觉模拟量表评分(22次)。结论:目前,传统功法治疗KOA的RCT研究中,所用的功法以太极拳、八段锦、易筋经居多。这些研究的中医辨证诊断不规范,缺乏长期随访,样本量差异较大,干预疗程不一;所选取的结局指标以症状/体征指标和生活质量指标居多,结局指标的选取存在未区分主次、数量差异大、替代指标针对性不强,以及客观性、安全性、远期疗效指标应用不足和对跌倒风险关注度较低等问题。
Objective:To analyze the current status of clinical randomized controlled trials(RCTs)on traditional Chinese exercises for treatment of knee osteoarthritis(KOA).Methods:All the RCTs about traditional Chinese exercises for treatment of KOA included from database’s inception to February 2025 were retrieved from the China National Knowledge Infrastructure,Wanfang Database,Vip Database,Chinese Biomedical Literature Service System,PubMed,Embase,Web of Science,and Cochrane Library through computer.The pertinent articles were screened,and the information,including the basic characteristics and outcome measures of the included RCTs,was extracted and analyzed.Results:①Literature search and screening results.Two thousand four hundred and twelve articles were searched out.After screening,67 articles were included in the final analysis,including 25 Chinese articles and 42 English articles.②Basic characteristics of the included RCTs.The included 67 studies were published between 2003 and 2024,the sample size was less than 60 participants in 21 studies,60-99 participants in 29 studies,100-200 participants in 12 studies,over 200 participants in 5 studies.The western medical diagnostic criteria for KOA was reported in all 67 studies,with 5 ones additionally reporting the TCM syndrome differentiation criteria.The intervention in the experimental group was traditional Chinese exercises alone in 41 studies and combined traditional Chinese exercises with other therapies in 26 studies.Five distinct traditional Chinese exercises were identified in the 67 studies,ranked in a descending order by the occurrence frequency as follows:shadow boxing,eight-sectioned exercise,Yi Jin Jing(易筋经),qigong(TCM),five mimic animal boxing,furthermore,a 12-week duration was predominant for both intervention period and follow-up time in the 67 studies.③Outcome measures in the included RCTs.Among the 67 studies,the outcome measures were assessed at two time points(pre-and post-intervention)in 45 studies,and at three time points(pre-,during,and post-intervention)in 21 studies.Moreover,26 studies explicitly distinguished between primary and secondary outcome measures,employing existing industry-standard assessment criteria,notably,one study utilized different assessment time points for primary and secondary outcome measures,and 41 studies did not differentiate primary and secondary outcome measures,exclusively relied on custom assessment criteria.Each study encompassed 1-13 outcome measures.Besides,86 distinct outcome measures were identified in the 67 studies and were taxonomized into 7 domains,including symptoms&signs(28),quality of life(20),physicochemical measures(15),imaging&biomechanical measures(12),other measures(6),safety measures(4)and long-term efficacy measures(1),respectively.In addition,the outcome measures were ranked in a descending order by the occurrence frequency,and the top 5 were Western Ontario and McMaster Universities osteoarthritis index(WOMAC)pain score(47 times),WOMAC function score(46 times),WOMAC stiffness score(43 times),balance&proprioception test(33 times),and visual analogue scale(VAS)pain score(22 times).Conclusion:Current RCTs on traditional Chinese exercises for KOA primarily focus on shadow boxing,eight-sectioned exercise,and Yi Jin Jing(易筋经).These studies exhibit critical methodological limitations such as non-standardized TCM syndrome differentiation,lack of long-term follow-up,substantial variation in sample size,and heterogeneous intervention durations,apart from that,the selected outcome measures predominantly focus on symptoms&signs,and quality of life,with the key issues such as failure to distinguish primary and secondary outcome measures,substantial variation in the number of measures,weak relevance of surrogate measures,insufficient application of objective,safety,and long-term efficacy measures,and lack of attention to fall risk assessment.
作者
李妍
许江南
徐志明
郭杨
王礼宁
刘孟敏
潘娅岚
马勇
司誉豪
LI Yan;XU Jiangnan;XU Zhiming;GUO Yang;WANG Lining;LIU Mengmin;PAN Yalan;MA Yong;SI Yuhao(Nanjing University of Chinese Medicine,Nanjing 210023,Jiangsu,China)
出处
《中医正骨》
2025年第7期41-48,65,共9页
The Journal of Traditional Chinese Orthopedics and Traumatology
基金
国家自然科学基金项目(82305268)
国家级大学生创新创业训练计划项目(202410315070Z)。
关键词
骨关节炎
膝
随机对照试验专题
结果评价
卫生保健
太极拳
八段锦
易筋经
五禽戏
气功(中医)
osteoarthritis,knee
randomized controlled trials as topic
outcome assessment,health care
Shadow Boxing
Eight-Sectioned Exercise
Yi Jin Jing
Five Mimic Animal Boxing
Qigong(TCM)
