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I型和III型水解胶原蛋白肽(CollaSel PRO)治疗骨关节炎的疗效和安全性评估:一项双盲、安慰剂对照、随机临床试验

Evaluation of the Efficacy and Safety of CollaSel PRO Type I and Type III Hydrolyzed Collagen Peptides in the Treatment of Osteoarthritis: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.

作者信息

Demir-Dora Devrim, Tuna Serpil, Kurtoglu Emel Dogan, Gursoy Savas, Balci Nilufer, Tezman Selim, Erenmemisoglu Aydin

机构信息

Department of Medical Pharmacology, Faculty of Medicine, Akdeniz University, 07070 Antalya, Turkey.

Department of Gene and Cell Therapy, Faculty of Medicine, Akdeniz University, 07070 Antalya, Turkey.

出版信息

J Clin Med. 2025 May 23;14(11):3655. doi: 10.3390/jcm14113655.

DOI:10.3390/jcm14113655
PMID:40507417
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12156922/
Abstract

: This study aims to evaluate the efficacy and safety of oral supplementation with hydrolyzed collagen peptides (HCP) type I and type III (CollaSel PRO) in reducing joint pain and stiffness and improving physical function in patients with osteoarthritis (OA). : In this randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT05369780; approved by the Institutional Review Board), 160 adult patients with OA (mean age 52.4 ± 4.3 years; 111 females, 49 males) were randomly assigned to receive either 10 g/day of CollaSel PRO (n = 80) or placebo (maltodextrin, n = 80) for 8 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate knee and hip joints, and the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHFS) was used for ankle joints. Assessments were conducted at baseline and at weeks 1, 4, and 8. : In the CollaSel PRO group, a significant decrease in WOMAC scores (mean ± SD 50.5 ± 17.0, 40.7 ± 16.9 and 33.8 ± 16.5 vs. 53.7 ± 16.9, respectively, < 0.001 for each) and significant increase in AOFAS-AHFS scores (64.2 ± 13.1, 73.6 ± 12.3 and 80.8 ± 9.9 vs. 61.8 ± 13.9, respectively, < 0.001 for each) were noted at weeks 1, 4, and 8 compared to the baseline scores. WOMAC scores were significantly lower in comparing HCP and placebo, and AOFAS-AHFS scores were higher in the HCP group compared to the placebo group at weeks 4 and 8 (all < 0.001). : CollaSel PRO appears to be a safe and effective option for the symptomatic management of osteoarthritis. It significantly improved joint pain, stiffness, and physical function in multiple joints. These improvements are not only statistically significant but also clinically meaningful, supporting the need for longer-term evaluation.

摘要

本研究旨在评估口服补充I型和III型水解胶原蛋白肽(HCP,CollaSel PRO)对减轻骨关节炎(OA)患者关节疼痛和僵硬以及改善身体功能的疗效和安全性。

在这项随机、双盲、安慰剂对照试验(ClinicalTrials.gov标识符:NCT05369780;经机构审查委员会批准)中,160例成年OA患者(平均年龄52.4±4.3岁;女性111例,男性49例)被随机分配接受每日10 g的CollaSel PRO(n = 80)或安慰剂(麦芽糊精,n = 80),为期8周。使用西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评估膝关节和髋关节,使用美国矫形足踝协会踝 - 后足评分量表(AOFAS - AHFS)评估踝关节。在基线以及第1、4和8周进行评估。

在CollaSel PRO组中,与基线评分相比,在第1、4和8周时WOMAC评分显著降低(均值±标准差分别为50.5±17.0、40.7±16.9和33.8±16.5,而基线为53.7±16.9,各对比P<0.001),AOFAS - AHFS评分显著升高(分别为64.2±13.1、73.6±12.3和80.8±9.9,而基线为61.8±13.9,各对比P<0.001)。在第4周和第8周时,与安慰剂相比,HCP组的WOMAC评分显著更低,AOFAS - AHFS评分更高(均P<0.001)。

CollaSel PRO似乎是骨关节炎症状管理的一种安全有效的选择。它显著改善了多个关节的疼痛、僵硬和身体功能。这些改善不仅具有统计学意义,而且具有临床意义,支持进行长期评估的必要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c0a3/12156922/f431d6b43f7a/jcm-14-03655-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c0a3/12156922/09fadd5e3e85/jcm-14-03655-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c0a3/12156922/f431d6b43f7a/jcm-14-03655-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c0a3/12156922/09fadd5e3e85/jcm-14-03655-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c0a3/12156922/f431d6b43f7a/jcm-14-03655-g002.jpg

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The Efficacy and Safety of CollaSel Pro Hydrolyzed Collagen Peptide Supplementation without Addons in Improving Skin Health in Adult Females: A Double Blind, Randomized, Placebo-Controlled Clinical Study Using Biophysical and Skin Imaging Techniques.无添加物的CollaSel Pro水解胶原蛋白肽补充剂对改善成年女性皮肤健康的疗效和安全性:一项采用生物物理和皮肤成像技术的双盲、随机、安慰剂对照临床研究。
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