口服鱼软骨水解物补充剂对患有膝关节疼痛和功能不适的成年人群的影响：一项结合探索性临床研究和离体临床研究的创新方法的结果。

Oral supplementation with fish cartilage hydrolysate in an adult population suffering from knee pain and function discomfort: results from an innovative approach combining an exploratory clinical study and an ex vivo clinical investigation.

机构信息

Service de Kinésithérapie et de Réadaptation Fonctionnelle, Hôpital Princesse Paola, Vivalia, Rue du Vivier 21, Marche-en-Famenne, 6900, Belgium.

musculoSKeletal Innovative research Lab (mSKIL), University of Liège, Liège, 4000, Belgium.

出版信息

BMC Musculoskelet Disord. 2023 Sep 21;24(1):748. doi: 10.1186/s12891-023-06800-4.

BACKGROUND

Aging is frequently associated with impairments of the musculoskeletal system and many elderly people experience joint discomfort or pain which might reduce their ability to move and consequently alter their quality of life. A beneficial effect of fish cartilage hydrolysate (FCH) on pain and joint function has recently been shown in an ACLT/pMMx osteoarthritis rat model.

METHODS

We therefore performed an exploratory, non-comparative, multi-centric clinical trial including 33 subjects with moderate knee joint discomfort and loss of functionality to investigate the efficacy of FCH on their algo-functional status. We further determined the potential health benefit of FCH in an original clinical ex vivo study investigating the role of FCH human metabolites on primary human chondrocytes.

RESULTS

FCH significantly improved knee pain and function, as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS). Moreover, FCH significantly reduced pain at rest and while walking, and patient global assessment (PGA), as assessed by the Visual Analogue Scale (VAS), and improved patients' quality of life (SF-36). FCH metabolites decreased the synthesis of catabolic factors (MMP-13) and pro-inflammatory mediators (NO, PGE2) and limited the inhibitory effect of IL-1β on the synthesis of cartilage matrix components (GAG and collagen).

CONCLUSIONS

Thus, these data provide insights on the mode of action of FCH in humans and contribute to explain how FCH may relieve pain and improve joint function in subjects with knee discomfort. Although these preliminary data need to be confirmed in a randomized controlled trial, they strongly support the potential health benefit of such an active ingredient.

TRIAL REGISTRATION

The study was registered on clinicaltrials.gov with the identifier NCT04420091 (09/06/2020).

背景

衰老常与肌肉骨骼系统的功能障碍相关，许多老年人会感到关节不适或疼痛，这可能会降低他们的活动能力，并因此改变他们的生活质量。鱼软骨水解物（FCH）对 ACLT/pMMx 骨关节炎大鼠模型中的疼痛和关节功能具有有益作用。

方法

因此，我们进行了一项探索性、非对照、多中心临床试验，纳入 33 名膝关节不适和功能丧失中度的受试者，以研究 FCH 对他们algofunctional 状态的疗效。我们还在一项原始临床离体研究中进一步确定了 FCH 的潜在健康益处，该研究调查了 FCH 对原代人软骨细胞的代谢物的作用。

结果

FCH 显著改善了膝关节疼痛和功能，评估方法为膝关节损伤和骨关节炎结果评分（KOOS）。此外，FCH 显著减轻了静息时和行走时的疼痛以及患者整体评估（PGA），评估方法为视觉模拟量表（VAS），并改善了患者的生活质量（SF-36）。FCH 代谢物减少了分解代谢因子（MMP-13）和促炎介质（NO、PGE2）的合成，并限制了 IL-1β 对软骨基质成分（GAG 和胶原蛋白）合成的抑制作用。