Departments of Orthopedic Surgery (C.H.J., S.Y.L., and K.S.Y.), Biostatistics (S.O.), and Laboratory Medicine (S.S.), SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.
J Bone Joint Surg Am. 2020 Dec 16;102(24):2129-2137. doi: 10.2106/JBJS.19.01411.
The use of platelet-rich plasma (PRP) for the treatment of rotator cuff disease is still controversial. The purpose of the present study was to investigate the safety and efficacy of a fully characterized allogeneic pure PRP injection into the subacromial space of patients with rotator cuff disease in comparison with corticosteroid injection.
A 2-group, parallel, assessor-blinded, randomized controlled trial was conducted. A total of 60 patients with clinically and structurally diagnosed rotator cuff disease were randomly assigned to receive a subacromial injection of either 4 mL of allogeneic pure PRP or a 4-mL mixture of 1 mL of 40-mg/mL triamcinolone acetonide and 3 mL of 2% lidocaine under ultrasonographic guidance. The primary outcomes were safety and the Constant score at 1 month. The secondary outcomes were pain, range of motion, muscle strength, functional scores, and overall satisfaction and function.
There were no treatment-related adverse events. The Constant score at 1 month did not significantly differ between the PRP and corticosteroid groups. At 6 months, the DASH (Disabilities of the Arm, Shoulder and Hand) score, overall function, and external rotation were significantly better in the PRP group than in the corticosteroid group, and the other clinical outcomes did not show significant differences. All pain measurements, the strength of the supraspinatus and infraspinatus, and 5 functional scores also improved slowly and steadily after injection, becoming significantly better at 6 months compared with those before the injection, whereas those in the corticosteroid group responded promptly but did not further improve.
Allogeneic PRP injections for the treatment of rotator cuff disease are safe but are not definitely superior to corticosteroid injections with respect to pain relief and functional improvement during 6 months. The DASH score, overall function, and external rotation were significantly better in the PRP group than in the steroid group at 6 months. Generally, PRP slowly but steadily reduced pain and improved function of the shoulder until 6 months, whereas corticosteroid did not.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
富血小板血浆（PRP）在肩袖疾病治疗中的应用仍存在争议。本研究旨在比较关节镜下肩峰下腔注射同种异体纯 PRP 与皮质类固醇治疗肩袖疾病的安全性和有效性。
采用 2 组平行、评估者设盲、随机对照试验。60 例经临床和结构诊断为肩袖疾病的患者随机分为两组，分别接受关节镜下肩峰下腔注射 4 mL 同种异体纯 PRP 或 4 mL 混合物（40mg/mL 曲安奈德 1 mL 和 2%利多卡因 3 mL）。主要结局为安全性和 1 个月时的 Constant 评分。次要结局为疼痛、活动范围、肌肉力量、功能评分以及总体满意度和功能。
两组均无治疗相关不良事件。PRP 组和皮质类固醇组在 1 个月时的 Constant 评分无显著差异。6 个月时，PRP 组的 DASH（上肢、肩和手功能障碍）评分、总体功能和外旋均显著优于皮质类固醇组，其他临床结局无显著差异。所有疼痛测量值、冈上肌和冈下肌力量以及 5 项功能评分在注射后也缓慢而稳定地改善，与注射前相比，6 个月时明显改善，而皮质类固醇组的反应迅速但没有进一步改善。
关节镜下肩峰下腔注射同种异体 PRP 治疗肩袖疾病安全，但在缓解疼痛和改善 6 个月内功能方面并不优于皮质类固醇注射。6 个月时，PRP 组的 DASH 评分、总体功能和外旋均显著优于皮质类固醇组。一般来说，PRP 可缓慢但稳定地减轻疼痛并改善肩部功能，直至 6 个月，而皮质类固醇则不能。
治疗水平 I。欲了解完整的证据水平说明，请参见作者须知。
