富血小板血浆治疗肩袖部分厚度撕裂或肌腱病患者可显著短期缓解疼痛和改善功能,优于皮质类固醇注射:一项双盲随机对照试验。
Platelet-Rich Plasma in Patients With Partial-Thickness Rotator Cuff Tears or Tendinopathy Leads to Significantly Improved Short-Term Pain Relief and Function Compared With Corticosteroid Injection: A Double-Blind Randomized Controlled Trial.
机构信息
Department of Surgery, Section of Orthopedic Surgery, University of Calgary, Calgary, Alberta, Canada.
Pan Am Clinic, Department of Orthopedics, University of Manitoba, Winnipeg, Manitoba, Canada.
出版信息
Arthroscopy. 2021 Feb;37(2):510-517. doi: 10.1016/j.arthro.2020.10.037. Epub 2020 Oct 28.
PURPOSE
To perform a randomized controlled trial comparing platelet-rich plasma (PRP) with standard corticosteroid (CS) injection in providing pain relief and improved function in patients with rotator cuff tendinopathy and partial-thickness rotator cuff tears (PTRCTs).
METHODS
This double-blind randomized controlled trial enrolled patients with ultrasound-proven or magnetic resonance imaging-proven PTRCTs who received either an ultrasound-guided PRP or CS injection. Patients completed patient-reported outcome assessments at baseline and at 6 weeks, 3 months, and 12 months after injection. The primary outcome was improvement in the visual analog scale (VAS) score for pain. Secondary outcomes included changes in American Shoulder and Elbow Surgeons (ASES) and Western Ontario Rotator Cuff Index (WORC) scores. Treatment failure was defined as subsequent injection, consent to undergo surgery, or operative intervention.
RESULTS
We followed up 99 patients (47 in the PRP group and 52 in the CS group) until 12 months after injection. There were no differences in baseline patient demographic characteristics including age, sex, or duration of symptoms. Despite randomization, patients in the PRP group had worse baseline VAS (46.0 vs 34.7, P = .01), ASES (53.9 vs 61.8, P = .02), and WORC (42.2 vs 49.5, P = .03) scores. At 3 months after injection, the PRP group had superior improvement in VAS (-13.6 vs 0.4, P = .03), ASES (13.0 vs 2.9, P = .02), and WORC (16.8 vs 5.8, P = .03) scores. There were no differences in patient-reported outcomes at 6 weeks or 12 months. There was no difference in the rate of failure (P = .31) or conversion to surgery (P = .83) between groups.
CONCLUSIONS
Patients with PTRCTs or tendinopathy experienced clinical improvement in pain and patient-reported outcome scores after both ultrasound-guided CS and PRP injections. Patients who received PRP obtained superior improvement in pain and function at short-term follow-up (3 months). There was no sustained benefit of PRP over CS at longer-term follow-up (12 months).
LEVEL OF EVIDENCE
Level I, randomized controlled trial.
目的
进行一项随机对照试验,比较富血小板血浆(PRP)与标准皮质类固醇(CS)注射在缓解肩袖肌腱病和部分厚度肩袖撕裂(PTRCT)患者疼痛和改善功能方面的效果。
方法
这项双盲随机对照试验纳入了经超声或磁共振成像证实患有 PTRCT 的患者,他们接受了超声引导下的 PRP 或 CS 注射。患者在基线和注射后 6 周、3 个月和 12 个月时完成患者报告的结果评估。主要结局是视觉模拟量表(VAS)疼痛评分的改善。次要结局包括美国肩肘外科医师协会(ASES)和安大略西部肩袖指数(WORC)评分的变化。治疗失败定义为随后进行注射、同意接受手术或手术干预。
结果
我们对 99 例患者(PRP 组 47 例,CS 组 52 例)进行了随访,直至注射后 12 个月。患者的基线人口统计学特征(包括年龄、性别或症状持续时间)无差异。尽管进行了随机分组,但 PRP 组患者的基线 VAS(46.0 比 34.7,P=0.01)、ASES(53.9 比 61.8,P=0.02)和 WORC(42.2 比 49.5,P=0.03)评分更差。注射后 3 个月时,PRP 组 VAS(-13.6 比 0.4,P=0.03)、ASES(13.0 比 2.9,P=0.02)和 WORC(16.8 比 5.8,P=0.03)评分的改善更优。在 6 周或 12 个月时,患者报告的结果无差异。两组之间的失败率(P=0.31)或转为手术的比例(P=0.83)无差异。
结论
患有 PTRCT 或肌腱病的患者接受超声引导下 CS 和 PRP 注射后,疼痛和患者报告的结果评分均有改善。接受 PRP 治疗的患者在短期随访(3 个月)时疼痛和功能改善更优。在长期随访(12 个月)时,PRP 并没有比 CS 更持久的优势。
证据等级
I 级,随机对照试验。