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超声引导下注射基于I型胶原蛋白的医疗器械治疗大转子疼痛综合征的疗效:一项初步研究。

Efficacy of Ultrasound-Guided Injections of Type I Collagen-Based Medical Device for Greater Trochanteric Pain Syndrome: A Pilot Study.

作者信息

Randelli Filippo, Fioruzzi Alberto, Mazzoleni Manuel Giovanni, Radaelli Alessandra, Rahali Leila, Verga Lucia, Menon Alessandra

机构信息

Hip Department-CAD, ASST Gaetano Pini-CTO, Piazza Cardinale Andrea Ferrari 1, 20122 Milano, Italy.

Scuola di Specializzazione in Ortopedia e Traumatologia, Università degli Studi di Milano, Via Festa del Perdono 7, 20122 Milano, Italy.

出版信息

Life (Basel). 2025 Feb 26;15(3):366. doi: 10.3390/life15030366.

Abstract

Greater Trochanteric Pain Syndrome (GTPS) is a frequent clinical condition characterized by acute or chronic pain in the lateral region of the hip. This condition is primarily due to gluteus minimus and medius tendinopathy. Swine-derived type I collagen has shown a positive effect on tenocytes through in vitro studies and on tendinopathies in clinical studies. This pilot study aims to evaluate the clinical effects of swine-derived type I collagen injections on pain, hip function, and strength in GTPS patients. The study group was treated with three ultrasound-guided swine-derived type I collagen injections once a week for three consecutive weeks. The primary endpoint was pain reduction of at least 3 points on the Numeric Rating Scale (NRS) at ten weeks. Secondary endpoints were NRS average reduction at rest and palpation, modified Harris Hip Score (mHHS), abductor strength, and magnetic resonance imaging (MRI) improvement at six months. 52 patients were screened, 47 enrolled, and 43 completed the study. The primary endpoint was reached by 60.5% of the patients. All secondary endpoints were also reached with statistical significance. Neither early nor late adverse effects were found. In this pilot study, ultrasound-guided peritrochanteric swine-derived type I collagen injections are safe and effective for most patients with GTPS included in the study. Further and more extensive confirmatory investigation studies with a longer follow-up are needed to confirm this pilot study's results and the clinical benefit's persistence.

摘要

大转子疼痛综合征(GTPS)是一种常见的临床病症,其特征为髋关节外侧区域出现急性或慢性疼痛。这种病症主要归因于臀小肌和臀中肌腱病。通过体外研究,猪源I型胶原蛋白已显示出对肌腱细胞有积极作用,在临床研究中对肌腱病也有积极作用。这项初步研究旨在评估猪源I型胶原蛋白注射对GTPS患者疼痛、髋关节功能和力量的临床效果。研究组接受了三次超声引导下的猪源I型胶原蛋白注射,每周一次,连续三周。主要终点是在十周时数字评分量表(NRS)上疼痛减轻至少3分。次要终点是静息和触诊时NRS平均降低值、改良Harris髋关节评分(mHHS)、外展肌力量以及六个月时磁共振成像(MRI)的改善情况。筛选了52例患者,47例入组,43例完成研究。60.5%的患者达到了主要终点。所有次要终点也均有统计学意义地达成。未发现早期或晚期不良反应。在这项初步研究中,超声引导下转子周围猪源I型胶原蛋白注射对研究中纳入的大多数GTPS患者是安全有效的。需要进行进一步且更广泛的有更长随访期的验证性研究,以证实这项初步研究的结果以及临床益处的持续性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4163/11944056/c0027ebe84d4/life-15-00366-g001.jpg

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