透明质酸治疗膝骨关节炎:低偏倚风险试验的更新荟萃分析。

Hyaluronan for knee osteoarthritis: an updated meta-analysis of trials with low risk of bias.

机构信息

Université Paris Diderot, UFR Médicale, Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Fédération de Rhumatologie , Paris , France ; Inserm U1132, Hôpital Lariboisière , Paris , France.

Department of Rheumatology , Henri Mondor Hospital , Creteil , France.

出版信息

RMD Open. 2015 May 14;1(1):e000071. doi: 10.1136/rmdopen-2015-000071. eCollection 2015.

Abstract

BACKGROUND

The effectiveness of intra-articular hyaluronic acid (IAHA) injection for knee osteoarthritis (KOA) is debated.

OBJECTIVES

To evaluate the effect of IAHA for patients with KOA by analysing data from trials of IAHA versus placebo with low risk of bias, to provide the highest level of evidence.

METHODS

A systematic review and meta-analysis was conducted. Randomised controlled trials (RCTs) with a low risk of bias (adequate randomisation and concealment and double-blind design) that investigated IAHA versus placebo (saline solution) injection were eligible. The primary efficacy measure was pain intensity and secondary outcome function at 3 months. The treatment effect was summarised with the standardised mean difference (SMD) calculated from differences in means of pain and function measures between treatment and control groups at 3 months. Trials were pooled by a random-effects model with DerSimonian and Laird weights. Statistical heterogeneity was explored by a visual exploration of forest plots and the I(2) statistic.

RESULTS

A total of eight RCTs (2 199 randomised patients) met our inclusion criteria. IAHA significantly reduced the pain intensity (SMD=-0.21, 95% CI (95% CI) -0.32 to -0.10) and improved function (SMD=-0.12, 95% CI -0.22 to -0.02). Trials showed no heterogeneity.

CONCLUSIONS

This meta-analysis of high-quality trials of IAHA versus placebo shows that IAHA provides a moderate but real benefit for patients with KOA.

摘要

背景

关节内透明质酸(IAHA)注射治疗膝骨关节炎(KOA)的疗效存在争议。

目的

通过分析低偏倚风险(充分随机化和隐匿设计以及双盲设计)的 IAHA 与安慰剂对照试验的数据,评估 IAHA 对 KOA 患者的疗效,以提供最高级别的证据。

方法

进行了系统评价和荟萃分析。合格的研究为低偏倚风险(充分随机化和隐匿设计以及双盲设计)的随机对照试验(RCT),这些试验比较了 IAHA 与安慰剂(生理盐水)注射。主要疗效指标为 3 个月时的疼痛强度和次要结局功能。治疗效果用标准均数差(SMD)来总结,SMD 是根据治疗组和对照组在 3 个月时的疼痛和功能测量值之间的差异计算得出的。采用随机效应模型和 DerSimonian 和 Laird 权重对试验进行汇总。通过森林图和 I²统计量对统计异质性进行了探索。

结果

共有 8 项 RCT(2199 名随机患者)符合纳入标准。IAHA 显著降低了疼痛强度(SMD=-0.21,95%置信区间(95%CI)-0.32 至-0.10)和改善了功能(SMD=-0.12,95%CI-0.22 至-0.02)。试验没有显示出异质性。

结论

这项针对 IAHA 与安慰剂的高质量试验的荟萃分析表明,IAHA 为 KOA 患者提供了一种适度但真实的益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/45fb/4613148/2cf9d698406e/rmdopen2015000071f01.jpg

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