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富血小板血浆注射治疗慢性肩袖肌腱病:一项为期1年随访的随机对照试验。

Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up.

作者信息

Kesikburun Serdar, Tan Arif Kenan, Yilmaz Bilge, Yaşar Evren, Yazicioğlu Kamil

机构信息

Serdar Kesikburun, Department of Physical Medicine and Rehabilitation, Turkish Armed Forces Rehabilitation Center, Gülhane Military Medical Academy, TSK Rehabilitasyon Merkezi 06530 Bilkent, Ankara, Turkey.

出版信息

Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/0363546513496542. Epub 2013 Jul 26.

Abstract

BACKGROUND

Rotator cuff tendinopathy (RCT) is a significant source of disability and loss of work. Platelet-rich plasma (PRP) has been suggested to be beneficial in the treatment of RCT.

PURPOSE

To investigate the effect of PRP injections on pain and shoulder functions in patients with chronic RCT.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

A total of 40 patients, 18 to 70 years of age, with (1) a history of shoulder pain for >3 months during overhead-throwing activities, (2) MRI findings of RCT or partial tendon ruptures, and (3) a minimum 50% reduction in shoulder pain with subacromial injections of an anesthetic were included in this placebo-controlled, double-blind randomized clinical trial. Patients were randomized into a PRP group (n = 20) or placebo group (n = 20). Patients received an ultrasound-guided injection into the subacromial space that contained either 5 mL of PRP prepared from autologous venous blood or 5 mL of saline solution. All patients underwent a 6-week standard exercise program. Outcome measures (Western Ontario Rotator Cuff Index [WORC], Shoulder Pain and Disability Index [SPADI], 100-mm visual analog scale [VAS] of shoulder pain with the Neer test, and shoulder range of motion) were assessed at baseline and at 3, 6, 12, and 24 weeks and 1 year after injection.

RESULTS

Comparison of the patients revealed no significant difference between the groups in WORC, SPADI, and VAS scores at 1-year follow-up (P = .174, P = .314, and P = .904, respectively). Similar results were found at other assessment points. Within each group, the WORC, SPADI, and VAS scores showed significant improvements compared with baseline at all time points (P < .001). In the range of motion measures, there were no significant group × time interactions.

CONCLUSION

At 1-year follow-up, a PRP injection was found to be no more effective in improving quality of life, pain, disability, and shoulder range of motion than placebo in patients with chronic RCT who were treated with an exercise program.

摘要

背景

肩袖肌腱病(RCT)是导致残疾和工作能力丧失的重要原因。富含血小板血浆(PRP)被认为对RCT的治疗有益。

目的

研究PRP注射对慢性RCT患者疼痛和肩部功能的影响。

研究设计

随机对照试验;证据等级,1级。

方法

本安慰剂对照、双盲随机临床试验纳入了40例年龄在18至70岁之间的患者,这些患者满足以下条件:(1)在过顶投掷活动中肩部疼痛病史超过3个月;(2)MRI检查发现RCT或部分肌腱断裂;(3)肩峰下注射麻醉剂后肩部疼痛至少减轻50%。患者被随机分为PRP组(n = 20)或安慰剂组(n = 20)。患者接受超声引导下向肩峰下间隙注射,注射物为5 mL由自体静脉血制备的PRP或5 mL生理盐水溶液。所有患者均接受为期6周的标准锻炼计划。在基线、注射后3周、6周、12周、24周和1年时评估结果指标(西安大略肩袖指数[WORC]、肩部疼痛和功能障碍指数[SPADI]、Neer试验中肩部疼痛的100 mm视觉模拟量表[VAS]以及肩部活动范围)。

结果

对患者的比较显示,在1年随访时,两组在WORC、SPADI和VAS评分方面无显著差异(分别为P = 0.174、P = 0.314和P = 0.904)。在其他评估点也发现了类似结果。在每组内,WORC、SPADI和VAS评分在所有时间点与基线相比均有显著改善(P < 0.001)。在活动范围测量方面,不存在显著的组×时间交互作用。

结论

在1年随访时,对于接受锻炼计划治疗的慢性RCT患者,发现PRP注射在改善生活质量、疼痛、功能障碍和肩部活动范围方面并不比安慰剂更有效。

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