关节腔内注射透明质酸与安慰剂治疗早中期膝骨关节炎的疗效差异:基于随机、双盲、对照、临床试验的Meta分析  

Effectiveness of intra-articular injection of hyaluronic acid versus placebo in the treatment of early and mid-stage knee osteoarthritis:a Meta-analysis based on randomized,double-blind,controlled,clinical trials

作　　者：杨威 陈泽华 易志勇 黄旭东 韩清民 张荣华[4] Yang Wei;Chen Zehua;Yi Zhiyong;Huang Xudong;Han Qingmin;Zhang Ronghua(The Third Clinical School of Guangzhou University of Chinese Medicine,Guangzhou 510405,Guangdong Province,China;The Fifth Clinical School of Guangzhou University of Chinese Medicine,Guangzhou 510405,Guangdong Province,China;Department of Sports Medicine,The Third Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,Guangdong Province,China;Jinan University,Guangzhou 510632,Guangdong Province,China)

机构地区：[1]广州中医药大学第三临床医学院,广东省广州市510405 [2]广州中医药大学第五临床医学院,广东省广州市510405 [3]广州中医药大学第三附属医院运动医学科,广东省广州市510405 [4]暨南大学,广东省广州市510632

出　　处：《中国组织工程研究》2021年第23期3760-3766,共7页Chinese Journal of Tissue Engineering Research

基　　金：重大疑难疾病中西医临床协作试点项目-退行性骨关节病(广东)(国中医药办医政发[2018]3号),协作单位项目负责人:韩清民。

摘　　要：目的:随着临床医师采用关节内注射透明质酸钠治疗早中期膝骨关节炎的广泛应用,对其疗效的争议日趋激烈,但缺乏高质量随机对照双盲临床研究的循证医学证据。文章基于关节内注射透明质酸钠治疗早中期膝骨关节炎的双盲随机对照临床研究,明确其客观疗效。方法:在中英文电子数据库(中国知网、万方、读秀学术、超星期刊、维普中文数据库和Web of Science、PubMed和Scopus英文数据库)中检索关节内注射透明质酸钠治疗膝骨关节炎的相关文献,筛选随机、双盲、对照临床试验,依据Cochrane手册6.1采用风险偏倚评估工具(Risk of bias table 2,RoB2)对纳入文献进行严格的质量评价,多数文献质量较高,提取反映疗效的敏感指标数据,采用Meta分析来整合评估。结果:共纳入11个随机、双盲、对照、临床试验,包括3034例患者。Meta分析结果发现:①与安慰剂组相比,关节内注射透明质酸钠的OMERACT-OARSI响应者数在各自研究观察的终点(RR=1.11,95%CI:1.05-1.18,P=0.0006)、注射后3个月(RR=1.10,95%CI:1.02-1.18,P=0.02)和注射后6个月(RR=1.07,95%CI:1.01-1.14,P=0.03)明显增多,但在注射后1个月两组无显著差异;②关节内注射透明质酸钠对疼痛的目测类比评分相对于基线的改变在注射后1个月(MD=2.71,95%CI:1.35-4.07,P<0.0001)和注射后6个月(MD=3.14,95%CI:0.81-5.47,P=0.008)明显优于安慰剂组,而在注射后3个月时两组无显著差异(MD=0.42,95%CI:-3.17-4.02,P=0.82);③关节内注射透明质酸钠患者的整体满意度评估及其相对于基线的变化明显优于安慰剂组;④两组应急情况下止痛药物的使用和治疗相关不良事件的发生无显著差异。结论:现有的随机、双盲、对照临床试验证据表明,关节内注射透明质酸钠治疗早中期膝骨关节炎患者半年后疗效确切,且能明显改善关节疼痛和患者治疗体验,但远期疗效有待于未来的进一步研究证实。OBJECTIVE: With the widespread use of intra-articular injection of sodium hyaluronate in the treatment of early and mid-stage knee osteoarthritis, thecontroversy about its efficacy has become increasingly fierce;however, there is a lack of evidence-based medical evidence from high-quality randomizedcontrolled double-blind clinical trials. Based on the double-blind randomized controlled clinical trials regarding intra-articular injection of sodiumhyaluronate in the treatment of early and mid-term knee osteoarthritis, this study aimed to clarify the objective curative effect and offer evidences for theclinical application.METHODS: CNKI, WanFang, Duxiu Academic, Chaoxing Journal, VIP, Web of Science, PubMed, and Scopus were searched for the relevant articles addressingintra-articular injections of sodium hyaluronate for knee osteoarthritis. And we screened double-blind randomized controlled clinical trials. According to theCochrane Handbook 6.1, a risk of bias assessment tool (Risk of bias table 2, RoB2) was used to strictly evaluate the quality of the included papers, most ofwhich are of high quality. The data of sensitive indicators that reflect therapeutic efficacy were extracted, and integrated for evaluation using the Meta-analysis.RESULTS: A total of 11 double-blind randomized controlled clinical studies were included, involving 3 034 patients. Meta-analysis results indicated that moreOMERACT-OARSI responders of the sodium hyaluronate group than the control group at the end of each study (relative ratio (RR)=1.11, 95% confidenceinterval (CI): 1.05-1.18, P=0.000 6), at 3 months after injection (RR=1.10, 95 %CI: 1.02-1.18, P=0.02) and at 6 months after injection (RR=1.07, 95% CI: 1.01-1.14, P=0.03). However, there was no significant difference between the two groups at 1 month after injection. Changes in the painful Visual Analogue Scalescore relative to the baseline were significantly better in the sodium hyaluronate group than the placebo group at 1 (mean difference (MD)=2.71, 95% CI: 1.35-4.07, P < 0.000 1) a

关 键 词：膝骨关节炎 透明质酸钠 疼痛 OMERACT-OARSI响应者 盲法 患者整体满意度 随机对照试验 META分析 

分 类 号：R453[医药卫生—治疗学] R363[医药卫生—临床医学]