中医康复疗法对中老年人膝骨性关节炎的多中心随机对照试验  

Multi-Center Randomized Controlled Trial on Traditional Chinese Medicine Rehabilitation Therapy for Knee Osteoarthritis in Middle-Aged and Elderly Patients

作　　者：陈晓琴 仲卫红 叶佳佳 李宇涛[3] 王缤毅 杨珊莉 CHEN Xiaoqin;ZHONG Weihong;YE Jiajia;LI Yutao;WANG Binyi;YANG Lishan(Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine,Fuzhou,Fujian 350003;Fujian Key Laboratory of Rehabilitation Technology,Fuzhou,Fujian 350003;Fujian University of Traditional Chinese Medicine,Fuzhou,Fujian,350122)

机构地区：[1]福建中医药大学附属康复医院,福建福州350003 [2]福建省康复技术重点实验室,福建福州350003 [3]福建中医药大学,福建福州350122

出　　处：《中医康复》2024年第12期1-6,共6页Traditional Chinese Medicine Rehabilitation

基　　金：福建省科技计划项目(2021Y4017);福建省康复技术重点试验室开放课题(XKF2023001);福建中医药大学中医骨伤科学学科开放课题(XGS2023007)。

摘　　要：目的:探讨中医康复方案对膝骨性关节炎(KOA)的临床疗效和安全性,为中医循证临床实践指南制定提供科学依据。方法:采用多中心、前瞻性、随机对照临床试验设计方案,从3个中心纳入符合KOA诊断标准的157例患者,用中央随机系统按照1:1的比例分为试验组和对照组,分别予中医康复疗法和物理疗法。于治疗前、治疗后及随访,采用西安大略和麦克马斯特大学骨关节炎指数(WOMAC)量表积分、疼痛视觉模拟评分(VAS)、膝功能结果调查-日常生活能力量表(KOS-ADLS)评分和计时起立-行走测试(TUG)评价关节疼痛、平衡能力和关节功能改善情况,同时记录不良事件。结果:最终有效病例143例,其中试验组71例,对照组72例。治疗后及随访,两组患者WOMAC积分、VAS评分、KOS-ADLS评分和TUG均较本组治疗前显著改善(P<0.001)。治疗后,两组WOMAC积分、VAS评分、KOS-ADLS评分和TUG相当(P>0.05)。随访时,两组VAS评分差异有统计学意义(P<0.05),WOMAC积分、KOS-ADLS评分相当(P>0.05)。结论:中医康复疗法治疗KOA安全而有效,能把膝关节迈步、平衡、负重的功能有机结合起来,与物理疗法疗效相当,可作为KOA的一线治疗方案推广。此外,中医康复方案更契合我国当下医健结合趋势,有利于患者自我康复,且在缓解关节疼痛、恢复下肢最佳功能状态方面可能更具优势。Objective:To explore the clinical efficacy and safety of Traditional Chinese Medicine Rehabilitation therapy on knee osteoarthritis and provide scientific basis for the formulation of TCM evidence-based clinical practice guidelines.Methods:Multicenter,prospective,randomized controlled clinical trial were used.A total of 157 patients with KOA were included from three centers in this study.Using a central randomization system,patients will be randomized(1:1)into groups receiving either traditional Chinese medicine rehabilitation therapy or physical therapy.The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),visual analog scale(VAS),knee outcome survey activities of daily living scale(KOS-ADLS)and time up and go test(TUG),were used to evaluate knee pain,balance and functional status while recording adverse events.All patients were evaluated at baseline,after the last treatment,and at the 1-month follow-up period.Results:There were 143 effective cases,71 in the treatment group and 72 in the control group.Compared with before treatment in the same group,WOMAC score,VAS score,KOS-ADLS score and TUG in both groups were improved significantly after last treatment and at the last follow-up(P<0.001).After the last treatment,the WOMAC score,VAS score,KOS-ADLS score,and TUG of the two groups were similar(P>0.05).At the last follow-up,the VAS scores were significant difference between the two groups(P<0.05),the WOMAC score and KOS-ADLS score was similar(P>0.05).There was no significantly difference in the safety(P>0.05).Conclusions:Traditional Chinese Medicine Rehabilitation therapy is safe and effective in the treatment of KOA,as effective as physical therapy,which can integrate the functions of knee stepping,balancing and weight-bearing.It can be used as the first-line of treatment for KOA.In addition,it is more in line with the current trend of healthcare integration in China,which is conducive to patients'self-rehabilitation and may be more advantageous in relieving knee pain and restoring the best f

关 键 词：膝骨性关节炎 中医康复疗法 针刺 推拿 南少林站桩功 多中心随机对照临床研究试验 

分 类 号：R274[医药卫生—中医骨伤科学]