美国批准的用于膝关节骨关节炎的粘弹性补充剂的安全性和有效性：一项对随机盐水对照试验的系统评价和荟萃分析。

Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials.

作者信息

Strand Vibeke, McIntyre Louis F, Beach William R, Miller Larry E, Block Jon E

机构信息

Stanford University School of Medicine, Palo Alto, CA, USA.

New York University Medical Center, White Plains, NY, USA.

出版信息

J Pain Res. 2015 May 7;8:217-28. doi: 10.2147/JPR.S83076. eCollection 2015.

BACKGROUND

Intra-articular injection of hyaluronic acid is a common, yet controversial, therapeutic option for patients with knee osteoarthritis (OA). The purpose of this research was to determine the safety and efficacy of US-approved viscosupplements for symptomatic knee OA.

METHODS

We searched MedLine and EMBase for randomized, sham-controlled trials evaluating safety and/or clinical efficacy of US-approved viscosupplements in patients with symptomatic knee OA. Knee pain severity and knee joint function were assessed at 4 to 13 weeks and 14 to 26 weeks. Safety outcomes included serious adverse events, treatment-related serious adverse events, patient withdrawal, and adverse event-related patient withdrawal occurring at any time during follow-up.

RESULTS

A total of 29 studies representing 4,866 unique patients (active: 2,673, control: 2,193) were included. All sham-controlled trials used saline injections as a control. Viscosupplementation resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to preinjection values, with standardized mean difference values ranging from 1.07 to 1.37 (all P<0.001). Compared to controls, standardized mean difference with viscosupplementation ranged from 0.38 to 0.43 for knee pain and 0.32 to 0.34 for knee function (all P<0.001). There were no statistically significant differences between viscosupplementation and controls for any safety outcome, with absolute risk differences of 0.7% (95% confidence interval [CI]: -0.2 to 1.5%) for serious adverse events, 0% (95% CI: -0.4 to 0.4%) for treatment-related serious adverse events, 0% (95% CI: -1.6 to 1.6%) for patient withdrawal, and 0.2% (95% CI: -0.4 to 0.8%) for adverse event-related patient withdrawal.

CONCLUSION

Intra-articular injection of US-approved viscosupplements is safe and efficacious through 26 weeks in patients with symptomatic knee OA.

背景

关节腔内注射透明质酸是膝骨关节炎（OA）患者常用但存在争议的治疗选择。本研究旨在确定美国批准的用于有症状膝骨关节炎的粘弹性补充剂的安全性和有效性。

方法

我们检索了MedLine和EMBase，查找评估美国批准的粘弹性补充剂对有症状膝骨关节炎患者安全性和/或临床疗效的随机、假对照试验。在4至13周和14至26周时评估膝关节疼痛严重程度和膝关节功能。安全结局包括严重不良事件、与治疗相关的严重不良事件、患者退出以及随访期间任何时间发生的与不良事件相关的患者退出。

结果

共纳入29项研究，涉及4866例患者（治疗组：2673例，对照组：2193例）。所有假对照试验均使用盐水注射作为对照。与注射前值相比，粘弹性补充剂在4至26周期间对膝关节疼痛和功能产生了非常大的治疗效果，标准化均值差值范围为1.07至1.37（所有P<0.001）。与对照组相比，粘弹性补充剂治疗的膝关节疼痛标准化均值差值范围为0.38至0.43，膝关节功能标准化均值差值范围为0.32至0.34（所有P<0.001）。在任何安全结局方面，粘弹性补充剂与对照组之间均无统计学显著差异，严重不良事件的绝对风险差值为0.7%（95%置信区间[CI]：-0.2至1.5%），与治疗相关的严重不良事件为0%（95%CI：-0.4至0.4%），患者退出为0%（95%CI：-1.6至1.6%），与不良事件相关的患者退出为0.2%（95%CI：-0.4至0.8%）。