澳大利亚悉尼大学David J. Hunter联合墨尔本大学Kim L. Bennell团队比较了关节内富含血小板血浆与安慰剂注射对膝骨关节炎患者疼痛和胫骨内侧软骨体积的影响。相关论文发表在2021年11月23日出版的《美国医学会杂志》上。

大多数临床指南不推荐富含血小板血浆（PRP）治疗膝骨关节炎（OA），因为缺乏关于症状和关节结构疗效的高质量证据，但指南强调需要进行严格的研究。尽管如此，PRP在膝关节OA中的应用仍在增加。

为了评估关节内注射PRP对症状性轻中度膝关节内侧OA患者症状和关节结构的影响，2017年8月24日至2019年7月5日，研究组在澳大利亚悉尼和墨尔本进行了一项随机、两组、安慰剂对照、双盲临床试验，共纳入288例社区中50岁及以上有症状的内侧膝关节骨性关节炎（Kellgren和Lawrence 2级或3级）患者。12个月的随访于2020年7月22日完成。

随机分组后，144名参与者接受每周3次关节内注射白细胞较少的PRP进行干预，使用市售产品；144名接受生理盐水安慰剂治疗。两个主要结局分别为12个月内膝关节疼痛总平均得分的变化（11分；范围0-10，得分越高表示疼痛越严重；最小临床重要差异为1.8分）和通过磁共振成像（MRI）评估的胫骨内侧软骨体积的百分比变化。在2个月和/或12个月的随访中，31个次要结局（25个症状相关和6个MRI评估）评估了疼痛、功能、生活质量、整体变化和关节结构。

288名随机分组的患者平均年龄为61.9岁，169名为女性（59%），269名（93%）完成了试验。在这两组中，140名参与者（97%）接受了全部3次注射。12个月后，PRP治疗组膝关节疼痛评分平均降低2.1分，安慰剂治疗组平均降低1.8分，组间差异不显著；两组胫骨内侧软骨体积分别平均缩小1.4%和1.2%，差异亦不显著。在31个预先指定的次要结局中，29个组间无显著差异。

研究结果表明，对于有症状的轻中度膝关节骨性关节炎患者中，关节内注射PRP与注射生理盐水安慰剂相比，在12个月时症状或关节结构改善方面没有显著差异。

附：英文原文

Title: Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis: The RESTORE Randomized Clinical Trial

Author: Kim L. Bennell, Kade L. Paterson, Ben R. Metcalf, Vicky Duong, Jillian Eyles, Jessica Kasza, Yuanyuan Wang, Flavia Cicuttini, Rachelle Buchbinder, Andrew Forbes, Anthony Harris, Shirley P. Yu, David Connell, James Linklater, Bing Hui Wang, Win Min Oo, David J. Hunter

Issue&Volume: 2021/11/23

Abstract:

Importance  Most clinical guidelines do not recommend platelet-rich plasma (PRP) for knee osteoarthritis (OA) because of lack of high-quality evidence on efficacy for symptoms and joint structure, but the guidelines emphasize the need for rigorous studies. Despite this, use of PRP in knee OA is increasing.

Objective  To evaluate the effects of intra-articular PRP injections on symptoms and joint structure in patients with symptomatic mild to moderate radiographic medial knee OA.

Design, Setting, and Participants  This randomized, 2-group, placebo-controlled, participant-, injector-, and assessor-blinded clinical trial enrolled community-based participants (n=288) aged 50 years or older with symptomatic medial knee OA (Kellgren and Lawrence grade 2 or 3) in Sydney and Melbourne, Australia, from August 24, 2017, to July 5, 2019. The 12-month follow-up was completed on July 22, 2020.

Interventions  Interventions involved 3 intra-articular injections at weekly intervals of either leukocyte-poor PRP using a commercially available product (n=144 participants) or saline placebo (n=144 participants).

Main Outcomes and Measures  The 2 primary outcomes were 12-month change in overall average knee pain scores (11-point scale; range, 0-10, with higher scores indicating worse pain; minimum clinically important difference of 1.8) and percentage change in medial tibial cartilage volume as assessed by magnetic resonance imaging (MRI). Thirty-one secondary outcomes (25 symptom related and 6 MRI assessed; minimum clinically important difference not known) evaluated pain, function, quality of life, global change, and joint structures at 2-month and/or 12-month follow-up.

Results  Among 288 patients who were randomized (mean age, 61.9 [SD, 6.5] years; 169 [59%] women), 269 (93%) completed the trial. In both groups, 140 participants (97%) received all 3 injections. After 12 months, treatment with PRP vs placebo injection resulted in a mean change in knee pain scores of 2.1 vs 1.8 points, respectively (difference, 0.4 [95% CI, 0.9 to 0.2] points; P=.17). The mean change in medial tibial cartilage volume was 1.4% vs 1.2%, respectively (difference, 0.2% [95% CI, 1.9% to 1.5%]; P=.81). Of 31 prespecified secondary outcomes, 29 showed no significant between-group differences.

Conclusions and Relevance  Among patients with symptomatic mild to moderate radiographic knee OA, intra-articular injection of PRP, compared with injection of saline placebo, did not result in a significant difference in symptoms or joint structure at 12 months. These findings do not support use of PRP for the management of knee OA.

DOI: 10.1001/jama.2021.19415

Source: https://jamanetwork.com/journals/jama/article-abstract/2786501