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在 1 年随访时,与皮质类固醇相比,富含血小板的血浆肩胛下注射在疼痛和功能结局方面提供了更大的改善:一项双盲随机对照试验。

Subacromial injection of platelet-rich plasma provides greater improvement in pain and functional outcomes compared to corticosteroids at 1-year follow-up: a double-blinded randomized controlled trial.

机构信息

Instituto de Ortopedia y Traumatología "Carlos E. Ottolenghi" Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.

Instituto de Ortopedia y Traumatología "Carlos E. Ottolenghi" Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.

出版信息

J Shoulder Elbow Surg. 2024 Dec;33(12):2563-2571. doi: 10.1016/j.jse.2024.06.012. Epub 2024 Aug 3.

Abstract

BACKGROUND

Studies evaluating the results of platelet-rich plasma (PRP) for the treatment of rotator cuff tendinopathy have demonstrated conflicting results and have been confounded by small patient samples, the absence of a control group, the combined analysis of isolated tendinopathies and rotator cuff tears, and insufficient reporting of PRP preparations. The purpose of this study was to perform a randomized controlled trial (RCT) comparing PRP with standard corticosteroid injections in providing pain relief and improved function in patients with rotator cuff tendinopathy.

METHODS

This was a double-blind RCT at a single center. We evaluated patients between 18 and 50 years old who had both a clinical and magnetic resonance imaging diagnosis of supraspinatus tendinopathy refractory to conservative treatment. A total of 50 patients received PRP treatment, whereas 50 patients received a corticosteroid, as a control group. Patients completed patient-reported outcome assessments at baseline and at 1, 3, 6 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 Standardized Shoulder Assessment Form (ASES) score, Single Assessment Numeric Evaluation (SANE) score, and the Pittsburgh Sleep Quality Index (PSQI). Treatment failure was defined as persistent pain at 3 months that required a subsequent injection.

RESULTS

The mean age was 27.7 years (±7.4). All the patients completed 12 months of clinical follow-up. At 12 months, patients in the PRP group showed a significantly greater improvement in the VAS score than patients in the corticosteroid group: 1.68 (0.6) vs. 2.3 (1.0) (P < .001). As well, at the 12-month follow-up, the 3 scores evaluated were significantly higher in patients treated with PRP than in patients treated with corticosteroid: ASES, 89.8 (6.3) vs. 78.0 (8.6) (P < .001); SANE, 89.2 (6.3) vs. 80.5 (9.6) (P < .001); and PSQI, 2.72 (0.6) vs. 4.02 (1.7) (P < .001). The overall failure rate was significantly higher in the corticosteroid group (30%) than in the PRP group (12%) (P < .01).

CONCLUSION

One subacromial PRP injection in patients with rotator cuff tendinopathy showed significantly superior and sustained pain-relieving and functional improvements compared with one corticosteroid subacromial injection assessed by 4 patient-reported outcome scales at the 12-month follow-up. Moreover, the overall failure rate was significantly higher in the corticosteroid group than in the PRP group.

摘要

背景

评估富含血小板血浆(PRP)治疗肩袖肌腱病的结果的研究得出了相互矛盾的结果,并且受到患者样本量小、缺乏对照组、孤立性肌腱病和肩袖撕裂的综合分析以及 PRP 制剂报告不充分的影响。本研究旨在进行一项随机对照试验(RCT),比较 PRP 与标准皮质类固醇注射在缓解肩袖肌腱病患者疼痛和改善功能方面的效果。

方法

这是一项在单一中心进行的双盲 RCT。我们评估了年龄在 18 至 50 岁之间的患者,他们均具有临床和磁共振成像诊断的肩袖上肌腱病,且对保守治疗有抵抗。50 名患者接受 PRP 治疗,50 名患者接受皮质类固醇作为对照组。患者在注射后 1、3、6 和 12 个月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生标准化肩评估表(ASES)评分、单一评估数字评估(SANE)评分和匹兹堡睡眠质量指数(PSQI)的变化。治疗失败定义为 3 个月时持续疼痛,需要进行后续注射。

结果

平均年龄为 27.7 岁(±7.4)。所有患者均完成了 12 个月的临床随访。在 12 个月时,PRP 组患者的 VAS 评分改善明显大于皮质类固醇组:1.68(0.6)vs. 2.3(1.0)(P<.001)。此外,在 12 个月的随访中,接受 PRP 治疗的患者的 3 项评分均明显高于接受皮质类固醇治疗的患者:ASES,89.8(6.3)vs. 78.0(8.6)(P<.001);SANE,89.2(6.3)vs. 80.5(9.6)(P<.001);PSQI,2.72(0.6)vs. 4.02(1.7)(P<.001)。皮质类固醇组的总体失败率(30%)明显高于 PRP 组(12%)(P<.01)。

结论

在肩袖肌腱病患者中,单次肩峰下 PRP 注射与单次肩峰下皮质类固醇注射相比,在 12 个月的随访中,通过 4 项患者报告的结局量表评估,显示出明显更优且持续的缓解疼痛和改善功能的效果。此外,皮质类固醇组的总体失败率明显高于 PRP 组。

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