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新型水解胶原蛋白配方治疗膝关节骨性关节炎症状患者的有效性:一项多中心回顾性临床研究。

Effectiveness of a novel hydrolyzed collagen formulation in treating patients with symptomatic knee osteoarthritis: a multicentric retrospective clinical study.

机构信息

Humanitas Clinical and Research Center, Via Alessandro Manzoni, 56, 20089 Rozzano, Milan, Italy.

Maria Cecilia Hospital - Cotignola, Via Madonna di Genova, 1, 48033 Cotignola, Ravenna, Italy.

出版信息

Int Orthop. 2021 Feb;45(2):375-380. doi: 10.1007/s00264-020-04616-8. Epub 2020 May 23.

Abstract

PURPOSE

Knee osteoarthritis (OA) is a musculoskeletal disorder that may have a heavy impact on the patients' quality of life. Intra-articular collagen injection may be a safe adjuvant. Recently, CHondroGrid (CG), a hydrolyzed (< 3 kDa) bovine collagen injectable formulation, has been placed on the market. The aim of this study was to investigate the safety and performance profile of CG.

METHODS

Patients affected by Kellgren Lawrence grade 1 to 4 knee OA and BMI < 30 were treated by administering three CG injections of 2 ml (4 mg) each (at 15 days and 45 days from the first one, respectively) and were followed up for six months after the last administration. Clinical records were retrospectively assessed to compare VAS, Lequesne and WOMAC total, pain, stiffness, and physical function scores collected at baseline and 15, 45, and 225 days after the first injection.

RESULTS

At the last follow-up, 70 patients (37 men and 33 women, aged 57.1 ± 14.5 years) treated with CG showed a 50% reduction in their median Lequesne score, a 50% reduction in their VAS score at rest and moving, and a ≥ 50% reduction for all other scores under consideration.

CONCLUSIONS

CG may be a safe and effective adjuvant in the treatment of symptomatic knee OA.

摘要

目的

膝骨关节炎(OA)是一种肌肉骨骼疾病,可能对患者的生活质量产生重大影响。关节内注射胶原蛋白可能是一种安全的辅助治疗方法。最近,一种名为 CHondroGrid(CG)的可水解(<3 kDa)牛胶原蛋白注射制剂已投放市场。本研究旨在探讨 CG 的安全性和性能特征。

方法

患有 Kellgren Lawrence 分级 1 至 4 级膝骨关节炎且 BMI<30 的患者接受 CG 治疗,共接受三次 2ml(4mg)注射(分别在第一次注射后的 15 天和 45 天),并在最后一次注射后六个月进行随访。回顾性评估临床记录,以比较基线和第一次注射后 15、45 和 225 天时的 VAS、Lequesne 和 WOMAC 总分、疼痛、僵硬和身体功能评分。

结果

在最后一次随访时,70 名接受 CG 治疗的患者(37 名男性和 33 名女性,年龄 57.1±14.5 岁)的 Lequesne 评分中位数降低了 50%,静息和活动时的 VAS 评分降低了 50%,所有其他考虑的评分均降低了≥50%。

结论

CG 可能是治疗膝关节骨关节炎症状的一种安全有效的辅助治疗方法。

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