자가 유래 혈소판 재생치료술 (Platelet-Rich Plasma Injections) : 발목 관절염에 이득이 없음

※ 작은 규모 비대조 연구들에서 있었던 추정 이득은 더 큰 무작위 시험에서 확인되지 않았습니다.

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환자 자신의 혈액을 원심분리 한 platelet-rich plasma (PRP)는 광범위 근골격 조건들에서 사용되어 왔으나 좋은 증거는 종종 빈약합니다. 메타분석들에서는 무릎 관절염에서 적당한 임상 이득을 보였고 작은 규모 비대조 연구들에서는 발목 관절염에서 약간의 가능성을 보였습니다. 이 연구에서는 연구자들은 방사선학적으로 입증된 tibiotalar arthritis 네덜란드 환자 100명에게 PRP 또는 saline을 투약하였습니다. 26주 째에, 두 그룹 모두 100점 만점 통증 scale에서 평균 10점의 개선을 보였으나 두 그룹의 의미 있는 차이는 없었습니다. 두 그룹 모두에서 이상 반응은 없었습니다.

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※ 적당한 이득이 있는 무릎 관절염에서 PRP 주사 사용과 달리, 발목 관절염에서 PRP 이득은 없었습니다. 이 연구는 사례 연구와 대조되지 않은 시험들의 분명한 가치와 무관하게, 최신 치료들에 대한 큰 대조 연구들에서의 평가 중요성을 상기시켜 줍니다.

Key Points

Question Do intra-articular platelet-rich plasma injections improve ankle symptoms and function in patients with ankle osteoarthritis?

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Findings In this randomized clinical trial that included 100 patients, treatment with 2 intra-articular platelet-rich plasma injections vs placebo injections with saline resulted in a mean change in the American Orthopaedic Foot and Ankle Society score (range, 0-100; higher scores indicate less pain and better function) of 10 vs 11 points over 26 weeks; the between-group difference was not statistically significant.

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Meaning These findings do not support the use of platelet-rich plasma injections for patients with ankle osteoarthritis.

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Abstract

Importance Approximately 3.4% of adults have ankle (tibiotalar) osteoarthritis and, among younger patients, ankle osteoarthritis is more common than knee and hip osteoarthritis. Few effective nonsurgical interventions exist, but platelet-rich plasma (PRP) injections are widely used, with some evidence of efficacy in knee osteoarthritis.

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Objective To determine the effect of PRP injections on symptoms and function in patients with ankle osteoarthritis.

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Design, Setting, and Participants A multicenter, block-randomized, double-blinded, placebo-controlled clinical trial performed at 6 sites in the Netherlands that included 100 patients with pain greater than 40 on a visual analog scale (range, 0-100) and tibiotalar joint space narrowing. Enrollment began on August 24, 2018, and follow-up was completed on December 3, 2020.

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Interventions Patients were randomly assigned (1:1) to receive 2 ultrasonography-guided intra-articular injections of either PRP (n = 48) or placebo (saline; n = 52).

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Main Outcomes and Measures The primary outcome was the validated American Orthopaedic Foot and Ankle Society score (range, 0-100; higher scores indicate less pain and better function; minimal clinically important difference, 12 points) over 26 weeks.

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Results Among 100 randomized patients (mean age, 56 years; 45 [45%] women), no patients were lost to follow-up for the primary outcome. Compared with baseline values, the mean American Orthopaedic Foot and Ankle Society score improved by 10 points in the PRP group (from 63 to 73 points [95% CI, 6-14]; P < .001) and 11 points in the placebo group (from 64 to 75 points [95% CI, 7-15]; P < .001). The adjusted between-group difference over 26 weeks was −1 ([95% CI, –6 to 3]; P = .56). One serious adverse event was reported in the placebo group, which was unrelated to the intervention; there were 13 other adverse events in the PRP group and 8 in the placebo group.

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Conclusions and Relevance Among patients with ankle osteoarthritis, intra-articular PRP injections, compared with placebo injections, did not significantly improve ankle symptoms and function over 26 weeks. The results of this study do not support the use of PRP injections for ankle osteoarthritis.

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Trial Registration Netherlands Trial Register: NTR7261

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REF. JAMA. 2021;326(16):1595-1605.

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