特立帕肽(rhPTH)在关节镜下肩袖修复后增强功能恢复的有效性:一项三盲随机临床试验。

IF 3.8 Q2 ORTHOPEDICS
JBJS Open Access Pub Date : 2025-09-23 eCollection Date: 2025-07-01 DOI:10.2106/JBJS.OA.25.00035
Mohammad Reza Guity, Amir Human Hoveidaei, Ali Soltani Farsani, Mohammad Poursalehian, Maryam Okhovat, Rezvan Ghaderpanah, Reza Sattarpour, Sina Afzal, Shahabaldin Beheshti Fard
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引用次数: 0

摘要

背景:肩袖撕裂是常见的肌肉骨骼损伤,经常需要手术干预,但再撕裂发生率显著。特立帕肽(重组人甲状旁腺激素,rhPTH)在动物研究中显示出促进骨和肌腱愈合的希望。然而,有限的人类数据存在的临床效益,当辅助使用在关节镜下肩袖修复。目的:在一项三盲、随机对照试验(RCT)中,研究全身给药特立帕肽是否能改善关节镜下肩袖修复术后的功能结局。方法:50例(50-80岁)退行性肩袖撕裂的成年患者(1:1)随机接受关节镜修复术后3个月每日皮下注射特立帕肽(20 μg)或安慰剂。盲法评估者在基线、6个月和1年对参与者进行评估。主要观察指标为美国肩肘外科医生评分。次要结果包括活动范围(ROM)、疼痛的视觉模拟评分(VAS)、夜间疼痛、止痛药的使用和肌腱完整性的磁共振成像(MRI)评估(Sugaya分类)。结果:最终纳入43例受试者(rhPTH组23例,对照组20例)。从基线到1年,rhPTH组和对照组在as评分、ROM和疼痛评分方面均表现出组内显著改善(p < 0.0001)。然而,在6个月或1年的随访中,在as评分(p = 0.87)、所有平面的ROM或VAS疼痛评分方面,组间无显著差异。1年的MRI评估显示类似的恢复率(8.7% vs. 10%, p = 0.94),表明特利帕肽在促进肌腱完整性方面没有显著优势。结论:在这项三盲随机对照试验中,特立帕肽在改善关节镜下肩袖修复术后1年的功能结局或降低复发率方面没有比安慰剂带来额外的益处。需要更大的随机对照试验,包括更广泛的患者群体,以充分阐明特立帕肽在提高肩袖修复结果中的作用。证据等级:二级。有关证据水平的完整描述,请参见作者说明。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Effectiveness of Teriparatide (rhPTH) in Enhancing Functional Recovery After Arthroscopic Rotator Cuff Repair: A Triple-Blind Randomized Clinical Trial.

Effectiveness of Teriparatide (rhPTH) in Enhancing Functional Recovery After Arthroscopic Rotator Cuff Repair: A Triple-Blind Randomized Clinical Trial.

Background: Rotator cuff tears are common musculoskeletal injuries frequently requiring surgical intervention, yet retears occur at a notable rate. Teriparatide (recombinant human parathyroid hormone, rhPTH) has shown promise in animal studies for enhancing bone and tendon healing. However, limited human data exist on its clinical benefits when used adjunctively in arthroscopic rotator cuff repairs.

Purpose: To investigate whether the systemic administration of teriparatide improves functional outcomes following arthroscopic rotator cuff repair in a triple-blind, randomized controlled trial (RCT).

Methods: Fifty adult patients (aged 50-80 years) with degenerative rotator cuff tears were randomized (1:1) to receive daily subcutaneous injections of either teriparatide (20 μg) or placebo for 3 months after arthroscopic repair. Blinded evaluators assessed participants at baseline, 6 months, and 1 year. The primary outcome was the American Shoulder and Elbow Surgeons (ASES) score. Secondary outcomes included range of motion (ROM), Visual Analog Scale (VAS) for pain, nighttime pain, painkiller use, and magnetic resonance imaging (MRI) assessment of tendon integrity (Sugaya classification).

Results: Final analyses included 43 participants (rhPTH group = 23, control group = 20). Both the rhPTH and control groups demonstrated significant within-group improvements in ASES scores, ROM, and pain scores from baseline to 1 year (p < 0.0001). However, no significant between-group differences were observed at the 6-month or 1-year follow-up for the ASES score (p = 0.87), ROM in all planes, or VAS pain scores. MRI evaluations at 1 year showed comparable retear rates (8.7% vs. 10%, p = 0.94), indicating no significant advantage of teriparatide in promoting tendon integrity.

Conclusion: In this triple-blind RCT, teriparatide did not confer additional benefits over placebo in improving functional outcomes or reducing retear rates 1 year after arthroscopic rotator cuff repair. Larger RCTs that include a broader patient population are required to fully clarify the role of teriparatide in enhancing rotator cuff repair outcomes.

Level of evidence: Level II. See Instructions for Authors for a complete description of levels of evidence.

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JBJS Open Access
JBJS Open Access Medicine-Surgery
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