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关节内注射治疗膝关节骨关节炎的随机试验。

A Randomized Trial of Intra-articular Injection Therapy for Knee Osteoarthritis.

机构信息

From the Department of Physical Medicine and Rheumatology, Balgrist University Hospital.

Unit for Clinical and Applied Research, Balgrist Campus.

出版信息

Invest Radiol. 2023 May 1;58(5):355-362. doi: 10.1097/RLI.0000000000000942. Epub 2022 Dec 27.

Abstract

BACKGROUND

Intra-articular injections are widely used for conservative treatment of knee osteoarthritis (OA). However, rigorous data are lacking regarding the comparative therapeutic effectiveness of these injections.

PURPOSE

The aim of this study was to compare clinical outcomes after intra-articular injections of glucocorticoid, hyaluronic acid, platelet-rich plasma (PRP), or placebo in patients with mild or moderate OA of the knee.

MATERIALS AND METHODS

In a double-blinded, placebo-controlled, single-center trial, we randomly assigned knees with early- to middle-stage knee OA (Kellgren-Lawrence grade 1-3) to an intra-articular injection with one of these substances: glucocorticoid, hyaluronic acid, PRP, or placebo. Primary outcome was pain reduction within 6 months after the injection, assessed with the numeric rating scale (NRS; range, 0-100). Secondary outcome parameters included WOMAC scores, Tegner Activity Scale, knee mobility, and adverse events. Finally, a linear mixed-effects model was calculated and corrected for possible patient and covariate effects.

RESULTS

One hundred twenty knees (30 knees per treatment group) in 95 patients (41 female) were included in the final analysis. The median age of patients was 60 years (interquartile range, 54.0-68.0). There was no evidence that the drug effects of primary and secondary outcome parameters differed over time. The median pain at baseline was 32.5 (interquartile range, 15.00-50.00) on NRS. The changes in pain level during the first 6 months compared with baseline were small (within ±5 points on NRS), whereas the intrapatient variability was large between -20 and +20 points. Secondary outcome parameters did not differ significantly among the groups. Kellgren-Lawrence grade did not have a statistically significant effect on pain reduction ( P = 0.61).

CONCLUSIONS

There is no evidence that knee injections with glucocorticoid, PRP, or hyaluronic acid have superior short- or long-term effects in patients with low pain level at baseline and early- to middle-stage knee OA when compared with placebo.

摘要

背景

关节内注射被广泛用于膝关节骨关节炎(OA)的保守治疗。然而,对于这些注射的比较治疗效果,缺乏严格的数据。

目的

本研究旨在比较膝关节轻度至中度 OA 患者关节内注射糖皮质激素、透明质酸、富含血小板的血浆(PRP)或安慰剂后的临床疗效。

材料和方法

在一项双盲、安慰剂对照、单中心试验中,我们将早期至中期膝关节 OA(Kellgren-Lawrence 分级 1-3)的膝关节随机分配至关节内注射以下物质之一:糖皮质激素、透明质酸、PRP 或安慰剂。主要结局是注射后 6 个月内疼痛减轻程度,采用数字评分量表(NRS;范围 0-100)评估。次要结局参数包括 WOMAC 评分、Tegner 活动量表、膝关节活动度和不良事件。最后,计算并校正了可能的患者和协变量影响的线性混合效应模型。

结果

95 名患者(41 名女性)的 120 个膝关节(每个治疗组 30 个膝关节)纳入最终分析。患者的中位年龄为 60 岁(四分位距,54.0-68.0)。没有证据表明主要和次要结局参数的药物作用随时间而不同。基线时 NRS 的中位数疼痛为 32.5(四分位距,15.00-50.00)。与基线相比,前 6 个月的疼痛水平变化较小(NRS 内±5 点),而患者内的变异性在-20 到+20 点之间较大。各组之间的次要结局参数无显著差异。Kellgren-Lawrence 分级对疼痛减轻没有统计学显著影响(P=0.61)。

结论

在基线疼痛水平较低且处于早期至中期膝关节 OA 的患者中,与安慰剂相比,膝关节内注射糖皮质激素、PRP 或透明质酸并没有显示出短期或长期的优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a82a/10090303/3e00501b5909/ir-58-355-g001.jpg

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