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一项多中心、随机、双盲、安慰剂对照临床试验,评估磷虾油、虾青素和口服透明质酸复合物对轻度骨关节炎人群关节健康的疗效和安全性。

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Krill Oil, Astaxanthin, and Oral Hyaluronic Acid Complex on Joint Health in People with Mild Osteoarthritis.

机构信息

US Nutraceuticals, Inc. d/b/a Valensa International, Eustis, FL 32726, USA.

NOVAREX Co., Ltd., 80, Osongsaengmyeong 14-ro, Osong-eup, Chueongju-si 28220, Republic of Korea.

出版信息

Nutrients. 2023 Aug 29;15(17):3769. doi: 10.3390/nu15173769.

Abstract

Osteoarthritis is a significant global health problem. Many patients seek more effective alternatives to nonsteroidal anti-inflammatory medicines or commercial supplements to manage joint pain and inflammation. FlexPro MD (FP-MD) combines krill oil, astaxanthin, and lower molecular weight hyaluronic acid to support joint health. A 12-week, randomized, double-blind, placebo-controlled trial compared the efficacy and safety of FP-MD and placebo once daily in participants (n = 100) with mild osteoarthritis of the knee or hip joint. For the primary endpoint of joint pain score, per-protocol participants (n = 75) in the FP-MD group (n = 37) had a statistically significantly greater mean reduction from baseline in the Korean Visual Analog Scale (K-VAS) at week 12 compared with participants in the placebo group (n = 38) (20.8 ± 16.16 mm vs. 10.6 ± 17.58, = 0.0105). The Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC) total score was also significantly improved in the FP-MD group at week 12 compared with placebo (-13.0 ± 13.62 vs. -5.5 ± 18.08, = 0.0489), especially an improvement in pain score (-2.5 ± 2.92 vs. -1.3 ± 3.94, = 0.02635). FP-MD group had greater improvement in joint function scoring by investigator assessment ( = 0.0127) and by group participants ( = 0.0070). A statistically significantly greater number of patients reported adverse events in the placebo group compared with the FP-MD group (16% vs. 4%, = 0.0455), most commonly gastrointestinal disorders in both of the groups. These findings suggest that FP-MD is well tolerated and can be effectively used to address joint pain in patients diagnosed with mild osteoarthritis, the main symptom of this condition.

摘要

骨关节炎是一个全球性的重大健康问题。许多患者寻求更有效的替代方案,以非甾体抗炎药或商业补充剂来管理关节疼痛和炎症。FlexPro MD(FP-MD)结合了磷虾油、虾青素和低分子量透明质酸,以支持关节健康。一项为期 12 周、随机、双盲、安慰剂对照试验比较了 FP-MD 和安慰剂在膝关节或髋关节轻度骨关节炎患者中的疗效和安全性,每日一次。对于主要终点关节疼痛评分,FP-MD 组的方案参与者(n=75)中,有统计学意义的从基线的韩国视觉模拟量表(K-VAS)评分在第 12 周的平均值显著降低,与安慰剂组相比(n=38)(20.8±16.16mm vs. 10.6±17.58mm, =0.0105)。FP-MD 组在第 12 周时的韩国西部安大略省和麦克马斯特大学骨关节炎指数(K-WOMAC)总分也显著改善,与安慰剂组相比(-13.0±13.62mm vs. -5.5±18.08mm, =0.0489),特别是疼痛评分的改善(-2.5±2.92mm vs. -1.3±3.94mm, =0.02635)。FP-MD 组在研究者评估和组内参与者评估的关节功能评分方面都有更大的改善( =0.0127 和 =0.0070)。与 FP-MD 组相比,安慰剂组报告不良事件的患者人数更多(16%vs.4%, =0.0455),两组最常见的不良事件均为胃肠道疾病。这些发现表明 FP-MD 耐受性良好,可有效用于治疗诊断为轻度骨关节炎的患者的关节疼痛,这是该疾病的主要症状。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db8f/10490060/0fe539ef1fae/nutrients-15-03769-g001.jpg

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