Background:Platelet-rich plasma (PRP) is increasingly used for the injection treatment of knee osteoarthritis (OA). However, the role of leukocytes contained in PRP is controversial, with some preclinical studies suggesting detrimental effects and others emphasizing their contribution in secreting bioactive molecules.Purpose:To compare the safety and effectiveness of leukocyte-rich PRP (LR-PRP) and leukocyte-poor PRP (LP-PRP) for the treatment of knee OA.Hypothesis:That leukocytes could influence results both in terms of adverse events and clinical outcomes.Study Design:Randomized controlled trial; Level of evidence, 1.Methods:This double-blind randomized controlled trial included 132 patients with Kellgren-Lawrence grade 1-3 knee OA who were randomized to a 3-injection cycle of either LR-PRP or LP-PRP. Patients were prospectively assessed at baseline and at 2, 6, and 12 months with subjective evaluations comprising the International Knee Documentation Committee (IKDC) subjective score, the KOOS (Knee injury and Osteoarthritis Outcome Score), the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), the visual analog scale for pain, the EuroQol–visual analog scale, the EuroQol–5 dimensions, and the Tegner activity scale. Objective evaluations consisted of the IKDC objective score, active/passive range of motion, and circumference of the index and contralateral knees. Patient judgment of the treatment was recorded as well as adverse reactions and failures.Results:An overall improvement in subjective and objective outcomes was documented, with no differences between the 2 groups, except for the improvement in the IKDC subjective score at 2 months, which was greater for the LR-PRP group compared with the LP-PRP group (14.8 ± 14.8 vs 8.6 ± 13.3, respectively; P = .046), as well as for active ( P = .021) and passive ( P = .040) ROM of the index knee at 6 months, showing statistically significant higher values in the LP-PRP group; and for quadriceps circumference of the index ( P = .042) and contralateral ( P = .045) knees at 12 months, which were significantly greater in the LR-PRP group. The IKDC subjective score improved from 42.5 ± 17.6 at baseline to 55.6 ± 21.4 at 12 months for the LR-PRP group ( P < .0005) and from 45.7 ± 16.4 to 55.3 ± 20.4 for the LP-PRP group ( P = .001). No differences in terms of patient treatment judgment were observed at all follow-up time points. No severe adverse events related to the treatment were reported, but some mild adverse events related to the treatment were observed: 16 in the LR-PRP group and 17 in the LP-PRP group. Treatment failed in 5 patients in the LR-PRP group and 2 in the LP-PRP group.Conclusion:This double-blind randomized controlled trial demonstrated that leukocytes did not affect the safety and efficacy of intra-articular PRP injections for the treatment of patients with knee OA. Both LR-PRP and LP-PRP demonstrated comparable clinical outcomes at all follow-up time points, without showing differences in subjective and objective outcomes or in adverse events and treatment failures.Registration:NCT04187183 (ClinicalTrials.gov).

中文翻译：

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白细胞不会影响富血小板血浆注射治疗膝骨关节炎的安全性和有效性：一项双盲随机对照试验


背景： 富血小板血浆 （PRP） 越来越多地用于膝骨关节炎 （OA） 的注射治疗。然而，PRP 中包含的白细胞的作用是有争议的，一些临床前研究表明有害影响，而另一些则强调它们在分泌生物活性分子中的作用。目的： 比较富白细胞 PRP （LR-PRP） 和白细胞贫乏 PRP （LP-PRP） 治疗膝关节 OA 的安全性和有效性。假设： 白细胞可以在不良事件和临床结果方面影响结果。研究设计： 随机对照试验;证据水平， 1.方法： 这项双盲随机对照试验包括 132 例 Kellgren-Lawrence 1-3 级膝关节 OA 患者，他们被随机分配到 LR-PRP 或 LP-PRP 的 3 次注射周期。在基线和 2、6 和 12 个月时对患者进行前瞻性评估，主观评估包括国际膝关节文献委员会 （IKDC） 主观评分、KOOS（膝关节损伤和骨关节炎结果评分）、WOMAC（西安大略大学和麦克马斯特大学骨关节炎指数）、疼痛视觉模拟量表、EuroQol-视觉模拟量表、EuroQol-5 维度、 和 Tegner 活动量表。客观评估包括 IKDC 客观评分、主动/被动运动范围以及指数和对侧膝关节的周长。记录患者对治疗的判断以及不良反应和失败。结果： 主客观结局总体改善，两组无差异，除了 2 个月时 IKDC 主观评分的改善，LR-PRP 组与 LP-PRP 组相比更大 （14.8 ± 14.8 vs 8.6 ± 13。3 个;P = .046），以及 6 个月时指数膝关节的主动 （P = .021） 和被动 （P = .040） ROM，在 LP-PRP 组中显示出统计学上显着的较高值;以及 12 个月时指数 （P = .042） 和对侧 （P = .045） 膝关节的股四头肌周长，LR-PRP 组的股四头肌周长显著更大。LR-PRP 组的 IKDC 主观评分从基线的 42.5 ± 17.6 提高到 12 个月时的 55.6 ± 21.4 （P < .0005），LP-PRP 组从 45.7 ± 16.4 提高到 55.3 ± 20.4 （P = .001）。在所有随访时间点均未观察到患者治疗判断的差异。未报告与治疗相关的严重不良事件，但观察到一些与治疗相关的轻度不良事件： LR-PRP 组 16 例，LP-PRP 组 17 例。LR-PRP 组 5 例患者和 LP-PRP 组 2 例患者治疗失败。结论： 这项双盲随机对照试验表明，白细胞不影响关节内 PRP 注射治疗膝关节 OA 患者的安全性和有效性。LR-PRP 和 LP-PRP 在所有随访时间点均表现出可比的临床结局，在主客观结局或不良事件和治疗失败方面均未表现出差异。注册：NCT04187183 （ClinicalTrials.gov）.