Department of Musculoskeletal Oncology, Guangdong Provincial Key Laboratory of Orthopedics and Traumatology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China (mainland).
Department of Orthopedic Surgery, Hui-Ya Hospital of The First Affiliated Hospital, Sun Yat-sen University, Huizhou, Guangdong, China (mainland).
Med Sci Monit. 2019 Aug 27;25:6436-6445. doi: 10.12659/MSM.916955.
BACKGROUND The aim of this study was to review the efficacy and safety of intra-articular (IA) viscosupplementation (VS) for hip osteoarthritis (OA). MATERIAL AND METHODS We searched Medline, Clinical Trial Register Center, EMBASE, and Cochrane databases for randomized controlled trials (RCTs) comparing VS with placebo injection for hip OA. We included suitable studies, assessed the quality of studies, and extracted data on pain reduction, function improvement at different time points, and safety profiles. The comparisons of pain and function outcome were performed by meta-analysis. RESULTS Five high-quality randomized controlled studies trials (RCTs) with 591 patients with hip OA were identified. Although several trials demonstrated a significant decline in pain in VS groups during follow-up compared to baseline, without severe adverse events, the pooled analysis did not show VS was superior to placebo at any time windows [7-14 days: standardized mean difference (SMD): -0.18; 95% CI, -0.47 to 0.10, p=0.21; 28-30 days: 0.02 (-0.15, 0.19), p=0.82; or at final visit: -0.14 (-0.46, 0.18), p=0.38]. Similar results were also observed in the combined data of functional results. CONCLUSIONS IA VS does not reduce pain or improve function significantly better than placebo in a short-term follow-up. The benefits and safety of VS should be further assessed by sufficiently-sized, methodologically sound studies with validated assessment of more clinically relevant end-points.
本研究旨在回顾关节内(IA)黏弹性补充(VS)治疗髋骨关节炎(OA)的疗效和安全性。
我们检索了 Medline、临床试验注册中心、EMBASE 和 Cochrane 数据库,以获取比较 VS 与安慰剂注射治疗髋 OA 的随机对照试验(RCT)。我们纳入了合适的研究,评估了研究的质量,并提取了不同时间点疼痛减轻、功能改善和安全性概况的数据。通过荟萃分析比较疼痛和功能结果。
共确定了 5 项高质量的随机对照研究试验(RCT),共 591 例髋 OA 患者。尽管几项试验表明 VS 组在随访期间疼痛明显下降,但没有严重的不良事件,汇总分析显示 VS 在任何时间窗口均不比安慰剂优越[7-14 天:标准化均数差(SMD):-0.18;95%CI,-0.47 至 0.10,p=0.21;28-30 天:0.02(-0.15,0.19),p=0.82;或最终就诊时:-0.14(-0.46,0.18),p=0.38]。功能结果的综合数据也观察到了类似的结果。
在短期随访中,IA VS 并未显著减轻疼痛或改善功能,优于安慰剂。VS 的益处和安全性应通过足够大小、方法合理、具有验证的更具临床相关性终点评估的研究进一步评估。