一项评估富血小板血浆疗法治疗退行性肌腱病有效性的初步研究：一项同步观察队列的随机对照试验。
A Pilot Study Evaluating the Effectiveness of Platelet-Rich Plasma Therapy for Treating Degenerative Tendinopathies: A Randomized Control Trial with Synchronous Observational Cohort.
作者信息
Wesner Marni, Defreitas Terry, Bredy Heather, Pothier Louisa, Qin Ziling, McKillop Ashley B, Gross Douglas P
机构信息
Glen Sather Sports Medicine Clinic, University of Alberta, Edmonton, Alberta, Canada.
Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada.
出版信息
PLoS One. 2016 Feb 5;11(2):e0147842. doi: 10.1371/journal.pone.0147842. eCollection 2016.
OBJECTIVE
This pilot study aimed to inform future research evaluating the effectiveness of Platelet Rich Plasma (PRP) injection for tendinopathy.
DESIGN
Randomized control trial (RCT) and synchronous observational cohort studies. For the RCT, consecutive consenting patients treated at an academic sports medicine clinic were randomly assigned to either a PRP or placebo control group.
SETTING
The Glen Sather Sport Medicine Clinic, Edmonton, Canada.
PATIENTS
The RCT included 9 participants with rotator cuff tendinopathy. The cohort study included 178 participants with a variety of tendinopathies.
INTERVENTIONS
Patients receiving PRP were injected with 4 ml of platelets into the supraspinatus and/or infraspinatus, while patients in the placebo group were injected with 4 ml of saline. All participants undertook a 3-month standardized, home-based, daily exercise program.
MAIN OUTCOME MEASURES
Participants in the RCT were re-evaluated 3, and 6 months post-injection. Change scores before and after injection on pain, disability and MRI-documented pathology outcomes were compared. In the cohort study, pain and disability were measured at 1, 2 and 3 months post-injection.
RESULTS
For the RCT, 7 participants received PRP and 2 received placebo injections. Patients receiving PRP reported clinically important improvements in pain (>1.5/10 on VAS), disability (>15 point DASH change), and tendon pathology while those receiving placebo injections did not. In the observational cohort, statistically and clinically significant improvements in pain and disability were observed.
CONCLUSION
This pilot study provides information for planning future studies of PRP effectiveness. Preliminary results indicate intratendinous, ultrasound-guided PRP injection may lead to improvements in pain, function, and MRI-documented tendon pathology.
TRIAL REGISTRATION
Controlled-Trials.com ISRCTN68341698.
目的
本初步研究旨在为未来评估富血小板血浆（PRP）注射治疗肌腱病有效性的研究提供信息。
设计
随机对照试验（RCT）和同步观察性队列研究。对于RCT，在一家学术运动医学诊所接受治疗且连续同意参与的患者被随机分配至PRP组或安慰剂对照组。
地点
加拿大埃德蒙顿的格伦·萨瑟运动医学诊所。
患者
RCT纳入了9名肩袖肌腱病患者。队列研究纳入了178名患有各种肌腱病的患者。
干预措施
接受PRP治疗的患者在冈上肌和/或冈下肌注射4毫升血小板，而安慰剂组患者注射4毫升生理盐水。所有参与者均进行了为期3个月的标准化居家每日锻炼计划。
主要观察指标
RCT参与者在注射后3个月和6个月进行重新评估。比较注射前后疼痛、功能障碍和MRI记录的病理结果的变化分数。在队列研究中，在注射后1个月、2个月和3个月测量疼痛和功能障碍。
结果
对于RCT，7名参与者接受了PRP注射，2名接受了安慰剂注射。接受PRP注射的患者在疼痛（视觉模拟评分法[VAS]上>1.5/10）、功能障碍（DASH变化>15分）和肌腱病理方面报告了具有临床意义的改善，而接受安慰剂注射的患者则没有。在观察性队列中，观察到疼痛和功能障碍在统计学和临床上均有显著改善。
结论
本初步研究为规划未来PRP有效性研究提供了信息。初步结果表明，超声引导下的肌腱内PRP注射可能会改善疼痛、功能以及MRI记录的肌腱病理情况。
试验注册
Controlled-Trials.com ISRCTN68341698。
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