超声引导下胶原蛋白医疗器械注射:髋关节骨关节炎疗效和安全性的实际评估。

Medical ultrasonography Pub Date : 2024-03-27 Epub Date: 2023-11-26 DOI:10.11152/mu-4242
Nemanja Damjanov, Mihaela C Micu
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引用次数: 0

摘要

目的:目前还缺乏用胶原蛋白细胞外生物支架治疗髋关节骨关节炎(OA)的相关数据。我们评估了在超声引导下关节内注射胶原蛋白医疗器械(CMD)治疗髋关节OA的效果:选取了44名凯尔格伦-劳伦斯分级(KLG)I级或II级的患者,其中20/44名随机选取的患者(CMD组)接受了每周2次连续的超声引导下关节内注射CMD(MD-HIP,Guna S.p.a.,意大利米兰)治疗。另外 24/44 名患者每天口服非甾体抗炎药(NSAIDs)(NSAIDs 组)。两组患者均在基线期和 1 个月后进行了临床评估、X 光检查和超声波检查,CMD 组在 3 个月后进行了临床评估、X 光检查和超声波检查。结果测量包括一般疼痛 VAS(0-10)、WOMAC 总分和 WOMAC 特定分值:结果:CMD组和非甾体抗炎药组在年龄、性别、VAS疼痛和WOMAC评分方面均无差异。结果:CMD 组和非甾体抗炎药组的年龄、性别、VAS 疼痛和 WOMAC 评分相同:与口服非甾体抗炎药治疗相比,超声引导下髋关节内注射CMD可明显改善VAS疼痛和WOMAC评分。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Ultrasound guided injection with Collagen-based Medical Device: real-life evaluation of efficacy and safety in hip osteoarthritis.

Aims: Data regarding the treatment of hip osteoarthritis (OA) with collagen-based extracellular bio-scaffolds are lacking. We evaluated the treatment of hip OA with ultrasound guided intraarticular injections of Collagen-based Medical Device (CMD).

Material and methods: Forty-four patients with Kellgren-Lawrence grade (KLG) I or II were selected, and 20/44 randomly selected patients (CMD group), were treated with 2 weekly consecutive ultrasound guided intraarticular injections of CMD (MD-HIP, Guna S.p.a. Milan, Italy). An additional 24/44 patients were treated with oral non-steroidal anti-inflammatory drugs (NSAIDs) daily (NSAIDs group). Clinical assessment, X-rays and ultrasound evaluation were performed at baseline, and after 1 month in both groups, and after 3 months in the CMD group. Outcome measures were general pain VAS (0-10), the whole WOMAC score, and the WOMAC specific subscores.

Results: CMD and NSAIDs group were homogenous for age, gender, VAS pain and WOMAC scores. The CMD group had significant improvement of the VAS pain (p<0.0001), global WOMAC score (p<0.0001) and WOMAC function (p<0.0001) from baseline to the 1st month, with further improvement from the 1st to the 3rd month (p<0,001; p<0.01; p<0.03, respectively). Significant improvement in WOMAC pain (p<0.0001) and WOMAC stiffness (p<0.0001) was detected at 1st month, with no significant change at 3rd month. In the NSAIDs group significant improvement in WOMAC function was detected after 1 month (p=0.021) only. No adverse events were recorded in the CMD and NSAIDs group.

Conclusion: The ultrasound guided intraarticular hip injections of CMD resulted in significant improvement in VAS pain and WOMAC scores compared to treatment with oral NSAIDs.

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