Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Servizio Trasfusionale Unico Metropolitano, Bologna, Italy.
Am J Sports Med. 2022 Mar;50(3):609-617. doi: 10.1177/03635465211064303. Epub 2022 Feb 1.
Platelet-rich plasma (PRP) is gaining large interest in clinical practice as a minimally invasive injective treatment for knee osteoarthritis (OA). Different preparation methods are available, and the presence of leukocytes, deemed detrimental in some preclinical studies, is one of the most debated aspects regarding PRP efficacy.
To compare the safety and effectiveness of leukocyte-rich PRP (LR-PRP) and leukocyte-poor PRP (LP-PRP) for the treatment of knee OA.
Randomized controlled trial; Level of evidence, 1.
A total of 192 patients with symptomatic knee OA (Kellgren-Lawrence grade 1-3) were randomly allocated to 3 weekly injections of LR-PRP or LP-PRP. LP-PRP was obtained with a filter for leukodepletion. LR-PRP and LP-PRP were divided into aliquots of 5 mL, with a mean platelet concentration of 1146.8 × 10/L and 1074.9 × 10/L and a mean leukocyte concentration of 7991.4 × 10/L and 0.1 × 10/L, respectively. Patients were evaluated at baseline and thereafter at 2, 6, and 12 months for the primary outcome, the International Knee Documentation Committee (IKDC) subjective score; and for secondary outcomes, the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales, EuroQol-visual analog scale (EQ-VAS), and Tegner score.
No differences between groups were observed in terms of absolute values or improvement of the clinical scores across all follow-up intervals. The mean IKDC subjective score at baseline and 12 months improved from 45.6 to 60.7 in the LR-PRP group as compared with 46.8 to 62.9 in the LP-PRP group ( = .626). No severe adverse events were described in either group, although 15 mild adverse events (knee pain or swelling) were reported: 12.2% for LR-PRP and 4.7% for LP-PRP ( = .101). No statistically significant difference was also found between LR-PRP and LP-PRP in terms of failures (7.8% vs 3.5%, = .331).
This double-blind randomized trial showed that 3 intra-articular LR-PRP or LP-PRP injections produced similar clinical improvement in the 12 months of follow-up in patients with symptomatic knee OA. Both treatment groups reported a low number of adverse events, without intergroup differences. The presence of leukocytes did not significantly affect the clinical results of PRP injections.
NCT02923700 (ClinicalTrials.gov identifier).
富血小板血浆（PRP）作为一种微创注射治疗膝骨关节炎（OA）的方法，在临床实践中受到广泛关注。有不同的制备方法，其中白细胞的存在被认为在一些临床前研究中是有害的，这是 PRP 疗效最具争议的方面之一。
比较富含白细胞的 PRP（LR-PRP）和白细胞减少的 PRP（LP-PRP）治疗膝 OA 的安全性和有效性。
随机对照试验；证据水平，1 级。
共有 192 例有症状的膝 OA 患者（Kellgren-Lawrence 分级 1-3）被随机分配接受 3 次每周注射 LR-PRP 或 LP-PRP。LP-PRP 通过白细胞去除过滤器获得。LR-PRP 和 LP-PRP 分为 5mL 等分，平均血小板浓度分别为 1146.8×10/L 和 1074.9×10/L，平均白细胞浓度分别为 7991.4×10/L 和 0.1×10/L。患者在基线时和此后 2、6 和 12 个月时进行主要结局（国际膝关节文献委员会（IKDC）主观评分）和次要结局（膝关节损伤和骨关节炎结果评分（KOOS）子量表、EuroQol 视觉模拟量表（EQ-VAS）和 Tegner 评分）评估。
在所有随访间隔内，两组之间的临床评分的绝对值或改善均无差异。LR-PRP 组的基线和 12 个月时的平均 IKDC 主观评分从 45.6 提高到 60.7，而 LP-PRP 组从 46.8 提高到 62.9（ =.626）。两组均未报告严重不良事件，但有 15 例轻度不良事件（膝关节疼痛或肿胀）：LR-PRP 组为 12.2%，LP-PRP 组为 4.7%（ =.101）。LR-PRP 和 LP-PRP 之间在失败率（7.8% vs 3.5%， =.331）方面也未发现统计学上的显著差异。
这项双盲随机试验表明，3 次关节内 LR-PRP 或 LP-PRP 注射在 12 个月的随访中在有症状的膝 OA 患者中产生了相似的临床改善。两组治疗均报告了较低数量的不良事件，且组间无差异。白细胞的存在并未显著影响 PRP 注射的临床结果。
NCT02923700（ClinicalTrials.gov 标识符）。
