Orthopedic Department, Hôpital Nord, AP-HM, Marseille, France; ICOS, Sport and Orthopedics Surgery Institute, Marseille, France.
Cell Therapy Laboratory, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, Marseille, France; Hematology and Vascular Biology Department, Hôpital de la Conception, AP-HM, Marseille, France; Vascular Research Center of Marseille, Aix-Marseille University, INSERM UMR 1076, Marseille, France.
Arthroscopy. 2018 May;34(5):1530-1540.e2. doi: 10.1016/j.arthro.2017.11.035. Epub 2018 Feb 1.
To assess the noninferiority of a single platelet-rich plasma (PRP) injection compared with hyaluronic acid (HA), to alleviate pain and enhance functional capacity in knee osteoarthritis, and identify biological characteristics of PRP that may affect their efficacy.
Fifty-four patients with symptomatic knee osteoarthritis received a single injection of either PRP (26 patients) or HA (28 patients). They were assessed at baseline and at 1, 3, and 6 months. The primary endpoint was the change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) score at 3 months, and secondary endpoints were responders' rate (improvement of at least 5 points or 40% of WOMAC total score at 3 months) of pain evaluation and patient's subjective satisfaction. Cell counts and the contents of vascular endothelial growth factor (VEGF), platelet-derived growth factor-AB (PDGF-AB), transforming growth factor beta 1 (TGF-β1) content of injected PRP were assessed to analyze their relationship with clinical outcome.
Both treatments proved their improvement in knee functional status and symptom relief, with a significant decrease observed at 1 month on all scores except for pain VAS in PRP group and WOMAC function score in the HA group. No difference between groups regarding WOMAC and VAS scores was observed. A higher percentage of responders was observed in the PRP group (72.7%) than in the HA group (45.8%) without significance (P = .064). The quantity of injected PDGF-AB and TGF-β1 correlated with the change in WOMAC scores at 3 months and was lower in responders than in nonresponders (P = .009 and P = .003, respectively).
Current results indicated that a single injection of very pure PRP offers a significant clinical improvement in the management of knee osteoarthritis, equivalent to a single HA injection in this patient population. Moreover, a significant correlation between the doses of TGF-β1 and PDGF-AB and the worsening of WOMAC score 3 months after the procedure was found.
Level II, randomized double blind controlled trial.
评估与透明质酸（HA）相比，单次富血小板血浆（PRP）注射在缓解膝关节骨关节炎疼痛和提高功能能力方面的非劣效性，并确定可能影响其疗效的 PRP 的生物学特性。
54 例有症状的膝关节骨关节炎患者分别接受 PRP（26 例）或 HA（28 例）单次注射。他们在基线时和 1、3 和 6 个月时进行评估。主要终点是 3 个月时的 Western Ontario 和 McMaster 大学关节炎指数（WOMAC）评分变化，次要终点是疼痛评估的应答者率（3 个月时 WOMAC 总分至少改善 5 分或 40%）和患者的主观满意度。评估注射 PRP 的细胞计数和血管内皮生长因子（VEGF）、血小板衍生生长因子-AB（PDGF-AB）、转化生长因子β1（TGF-β1）含量，分析其与临床结果的关系。
两种治疗方法均证明了对膝关节功能状态和症状缓解的改善，除 PRP 组疼痛 VAS 和 HA 组 WOMAC 功能评分外，所有评分在 1 个月时均有显著下降。组间 WOMAC 和 VAS 评分无差异。PRP 组的应答者比例（72.7%）高于 HA 组（45.8%），但无统计学意义（P=.064）。注射 PDGF-AB 和 TGF-β1 的量与 3 个月时 WOMAC 评分的变化相关，且在应答者中低于无应答者（P=.009 和 P=.003）。
目前的结果表明，单次注射非常纯净的 PRP 可显著改善膝关节骨关节炎的治疗效果，在该患者人群中与单次 HA 注射效果相当。此外，还发现 TGF-β1 和 PDGF-AB 的剂量与术后 3 个月 WOMAC 评分的恶化之间存在显著相关性。
二级，随机双盲对照试验。
