关节内富血小板血浆与安慰剂注射对膝关节骨性关节炎患者疼痛

结论和相关性 在有症状的轻度至中度膝关节 OA 患者中,关节内注射 PRP 与注射盐水安慰剂相比,在 12 个月时症状或关节结构没有显着差异。这些发现不支持使用 PRP 治疗膝关节 OA。

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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

    关节内富血小板血浆与安慰剂注射对膝关节骨性关节炎患者疼痛和胫骨内侧软骨体积的影响 RESTORE 随机临床试验

  • 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.

    大多数临床指南不推荐富血小板血浆 (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 中的使用正在增加。

  • 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.

    目的 评估关节内注射 PRP 对症状性轻至中度膝关节内侧 OA 患者症状和关节结构的影响。

  • 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.

    设计、设置和参与者 这项随机、两组、安慰剂对照、参与者、注射者和评估者盲法的临床试验招募了年龄在 50 岁或以上的有症状的膝关节内侧 OA 的社区参与者 (n = 288)。(Kellgren 和 Lawrence 2 或 3 级)于 2017 年 8 月 24 日至 2019 年 7 月 5 日在澳大利亚悉尼和墨尔本进行。为期 12 个月的随访于 2020 年 7 月 22 日完成。

  • 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).

     干预措施包括使用市售产品(n = 144 名参与者)或生理盐水安慰剂(n = 144 名参与者)以每周间隔 3 次关节内注射白细胞贫乏的 PRP。

  • 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.

    主要结果和测量 2 个主要结果是 12 个月内平均膝关节疼痛评分的变化(11 分制;范围,0-10,评分越高表示疼痛越严重;最小临床重要差异为 1.8)和内侧膝关节疼痛评分的百分比变化通过磁共振成像 (MRI) 评估的胫骨软骨体积。31 项次要结局(25 项症状相关和 6 项 MRI 评估;最小临床重要差异未知)在 2 个月和/或 12 个月的随访中评估疼痛、功能、生活质量、整体变化和关节结构。

  • 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.

    结果 在随机分组的 288 名患者中(平均年龄 61.9 [SD,6.5] 岁;169 [59%] 名女性),269 (93%) 名完成了试验。在两组中,140 名参与者 (97%) 接受了所有 3 次注射。12 个月后,PRP 与安慰剂注射治疗导致膝关节疼痛评分的平均变化分别为 -2.1 和 -1.8 分(差异,-0.4 [95% CI,-0.9 至 0.2] 分;P =0.17) .内侧胫骨软骨体积的平均变化分别为 -1.4% 和 -1.2%(差异,-0.2% [95% CI,-1.9% 至 1.5%];P = 0.81)。在 31 个预先设定的次要结果中,29 个没有显示出显着的组间差异。

  • 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.

    结论和相关性 在有症状的轻度至中度膝关节 OA 患者中,关节内注射 PRP 与注射盐水安慰剂相比,在 12 个月时症状或关节结构没有显着差异。这些发现不支持使用 PRP 治疗膝关节 OA。

主要统计结果:

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Primary Outcomes:

At 12 months, PRP injection was not more effective than saline placebo injection on either primary outcome (Table 2 and Figure 2). For change in pain scores, the between-group mean difference was not statistically significant (−0.4 [95% CI,−0.9 to 0.2] points), favoring PRP. In within-group analyses, each group had a mean change in pain scores (PRP group,−2.1 [SD, 2.7]; placebo group,−1.8 [SD, 2.5] points) that exceeded the MCID. For percentage change in medial tibial cartilage volume, the between-group mean difference was not statistically significant (−0.2% [95% CI,−1.9% to 1.5%]), with a mean change of−1.4% (SD, 7.2%) in the PRP group and a mean change of−1.2% (SD, 7.2%) in the placebo group.

     在 12 个月时,PRP 注射在任一主要结果方面并不比盐水安慰剂注射更有效(表 2 和图 2)。对于疼痛评分的变化,组间平均差异无统计学意义(-0.4 [95% CI,-0.9 至 0.2] 分),有利于 PRP。在组内分析中,每组疼痛评分的平均变化(PRP 组,-2.1 [SD,2.7];安慰剂组,-1.8 [SD,2.5] 分)超过 MCID。对于内侧胫骨软骨体积的百分比变化,组间平均差异无统计学意义(-0.2% [95% CI,-1.9% 至 1.5%]),平均变化为 -1.4%(SD,7.2% ) 在 PRP 组中,安慰剂组的平均变化为 -1.2% (SD, 7.2%)。

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Secondary Outcomes:

There was no statistically significant beneficial effect of PRP on overall pain at the 2-month secondary time point. None of the other 24 secondary outcomes that measured symptoms at 2 and 12 months were statistically significantly different between the 2 groups, except for global improvement.The number of participants in the PRP group who reported global improvement overall was statistically significantly greater than in the placebo group at 2 months (PRP group, 68/141 [48.2%] vs placebo group, 51/141 [36.2%]; risk ratio, 1.37 [95% CI, 1.05-1.80]; P = .02).

     PRP 在 2 个月的次要时间点对整体疼痛没有统计学意义的有益影响。除了整体改善外,两组在 2 个月和 12 个月时测量症状的其他 24 项次要结局均无统计学显着差异。在 2 个月时,报告总体改善的 PRP 组参与者人数在统计学上显着高于安慰剂组(PRP 组,68/141 [48.2%] vs 安慰剂组,51/141 [36.2%];风险比, 1.37 [95% CI, 1.05-1.80];P = .02)。

The number of participants in the PRP group who had 3 or more areas of cartilage thinning was statistically significantly greater than in the placebo group (PRP group, 24/140 [17.1%] vs placebo group, 9/133 [6.8%]; risk ratio, 2.71 [95% CI, 1.16-6.34]; P = .02).

     PRP 组中有 3 个或更多软骨变薄区域的参与者数量在统计学上显着高于安慰剂组(PRP 组,24/140 [17.1%] vs 安慰剂组,9/133 [6.8%];风险比率,2.71 [95% CI,1.16-6.34];P = .02)。

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