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关节内注射 I 型胶原缓解膝关节疼痛:一项双盲、随机对照试验。

Intra-articular Injection of Type I Atelocollagen to Alleviate Knee Pain: A Double-Blind, Randomized Controlled Trial.

机构信息

Department of Orthopedic Surgery, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

Department of Orthopedic Surgery, Konkuk University Medical Center, School of Medicine, Konkuk University, Seoul, Republic of Korea.

出版信息

Cartilage. 2021 Dec;13(1_suppl):342S-350S. doi: 10.1177/1947603519865304. Epub 2019 Aug 2.

Abstract

OBJECTIVE

Collagen disruption is one of the underlying causes of knee pain in patients with osteoarthritis and/or diverse cartilage defects. Atelocollagen is a type of collagen that lacks telopeptides and thus has reduced antigenicity. The intra-articular injection of type I atelocollagen supplements collagen levels in the disrupted articular cartilage. This randomized controlled trial evaluated the effects of the intra-articular injection of atelocollagen for the management of knee pain.

DESIGN

Two hundred patients with osteoarthritis, chondromalacia, or other cartilage defects were randomly assigned to receive a 3-mL intra-articular injection of atelocollagen (BioCollagen group) or saline (Placebo group). Clinical improvement was evaluated over a 24-week period using the 100-mm visual analogue scale (VAS), the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and the 36-item Short-Form Health Survey (SF-36).

RESULTS

VAS scores were significantly better in the BioCollagen group as compared with the Placebo group at 24 weeks. More patients in the BioCollagen group reported exceeding 20% and 40% VAS improvements. The WOMAC and SF-36 scores were also significantly improved from baseline after the intra-articular injection of atelocollagen; although, the differences between the BioCollagen and Placebo groups were not significant. There were no unexpected or severe adverse events reported for either group.

CONCLUSIONS

The results show that an intra-articular injection of atelocollagen effectively alleviates knee pain, as intended. Therefore, the intra-articular injection of atelocollagen can be considered an alternative solution to controlling knee pain due to osteoarthritis and diverse cartilage defects.

摘要

目的

胶原蛋白的破坏是骨关节炎和/或多种软骨缺陷患者膝关节疼痛的根本原因之一。无端胶原蛋白是一种缺乏末端肽的胶原蛋白,因此抗原性降低。I 型无端胶原蛋白的关节内注射补充了破坏的关节软骨中的胶原蛋白水平。这项随机对照试验评估了关节内注射无端胶原蛋白治疗膝关节疼痛的效果。

设计

200 名骨关节炎、软骨软化症或其他软骨缺陷患者被随机分为接受 3 毫升关节内注射无端胶原蛋白(BioCollagen 组)或生理盐水(安慰剂组)。在 24 周的时间内,使用 100 毫米视觉模拟量表(VAS)、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)和 36 项简短健康调查问卷(SF-36)评估临床改善情况。

结果

与安慰剂组相比,BioCollagen 组在 24 周时 VAS 评分显著更好。更多的 BioCollagen 组患者报告 VAS 改善超过 20%和 40%。WOMAC 和 SF-36 评分在关节内注射无端胶原蛋白后也从基线显著改善;尽管 BioCollagen 和安慰剂组之间的差异没有统计学意义。两组均未报告意外或严重不良事件。

结论

结果表明,关节内注射无端胶原蛋白能有效缓解膝关节疼痛,符合预期。因此,关节内注射无端胶原蛋白可以被认为是控制骨关节炎和多种软骨缺陷引起的膝关节疼痛的另一种解决方案。

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