關節內富血小板血漿與安慰劑注射對膝關節骨性關節炎患者疼痛

大多數臨床指南不推薦富血小板血漿 (PRP) 治療膝骨關節炎 (OA),因為缺乏關於症狀和關節結構療效的高品質證據,但指南強調需要進行嚴格的研究。

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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

    關節內富血小板血漿與安慰劑注射對膝關節骨性關節炎患者疼痛和脛骨內側軟骨體積的影響 RESTORE 隨機臨床試驗

  • 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.

    大多數臨床指南不推薦富血小板血漿 (PRP) 治療膝骨關節炎 (OA),因為缺乏關於症狀和關節結構療效的高品質證據,但指南強調需要進行嚴格的研究。儘管如此,PRP 在膝關節 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 評估關節內注射 PRP 對症狀性輕至中度膝關節內側 OA 患者症狀和關節結構的影響。

  • 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.

    設計、設置和參與者 這項隨機、兩組、安慰劑對照、參與者、注射者和評估者盲法的臨床試驗招募了年齡在 50 歲或以上的有症狀的膝關節內側 OA 的社區參與者 (n = 288)。(Kellgren 和 Lawrence 2 或 3 級)于 2017 年 8 月 24 日至 2019 年 7 月 5 日在澳大利亞雪梨和墨爾本進行。為期 12 個月的隨訪于 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).

     干預措施包括使用市售産品(n = 144 名參與者)或生理鹽水安慰劑(n = 144 名參與者)以每週間隔 3 次關節內注射白細胞貧乏的 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.

    主要結果和測量 2 個主要結果是 12 個月內平均膝關節疼痛評分的變化(11 分制;範圍,0-10,評分越高表示疼痛越嚴重;最小臨床重要差異為 1.8)和內側膝關節疼痛評分的百分比變化通過磁共振成像 (MRI) 評估的脛骨軟骨體積。31 項次要結局(25 項症狀相關和 6 項 MRI 評估;最小臨床重要差異未知)在 2 個月和/或 12 個月的隨訪中評估疼痛、功能、生活品質、整體變化和關節結構。

  • 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.

    結果 在隨機分組的 288 名患者中(平均年齡 61.9 [SD,6.5] 歲;169 [59%] 名女性),269 (93%) 名完成了試驗。在兩組中,140 名參與者 (97%) 接受了所有 3 次注射。12 個月後,PRP 與安慰劑注射治療導致膝關節疼痛評分的平均變化分別為 -2.1 和 -1.8 分(差異,-0.4 [95% CI,-0.9 至 0.2] 分;P =0.17) .內側脛骨軟骨體積的平均變化分別為 -1.4% 和 -1.2%(差異,-0.2% [95% CI,-1.9% 至 1.5%];P = 0.81)。在 31 個預先設定的次要結果中,29 個沒有顯示出顯著的組間差異。

  • 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.

    結論和相關性 在有症狀的輕度至中度膝關節 OA 患者中,關節內注射 PRP 與注射鹽水安慰劑相比,在 12 個月時症狀或關節結構沒有顯著差異。這些發現不支援使用 PRP 治療膝關節 OA。

主要統計結果:

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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 個月時,PRP 注射在任一主要結果方面並不比鹽水安慰劑注射更有效(表 2 和圖 2)。對於疼痛評分的變化,組間平均差異無統計學意義(-0.4 [95% CI,-0.9 至 0.2] 分),有利於 PRP。在組內分析中,每組疼痛評分的平均變化(PRP 組,-2.1 [SD,2.7];安慰劑組,-1.8 [SD,2.5] 分)超過 MCID。對於內側脛骨軟骨體積的百分比變化,組間平均差異無統計學意義(-0.2% [95% CI,-1.9% 至 1.5%]),平均變化為 -1.4%(SD,7.2% ) 在 PRP 組中,安慰劑組的平均變化為 -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 個月的次要時間點對整體疼痛沒有統計學意義的有益影響。除了整體改善外,兩組在 2 個月和 12 個月時測量症狀的其他 24 項次要結局均無統計學顯著差異。在 2 個月時,報告總體改善的 PRP 組參與者人數在統計學上顯著高於安慰劑組(PRP 組,68/141 [48.2%] vs 安慰劑組,51/141 [36.2%];風險比, 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 組中有 3 個或更多軟骨變薄區域的參與者數量在統計學上顯著高於安慰劑組(PRP 組,24/140 [17.1%] vs 安慰劑組,9/133 [6.8%];風險比率,2.71 [95% CI,1.16-6.34];P = .02)。

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