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透明质酸、氨基葡萄糖和软骨素的液体组合作为一种膳食补充剂,用于治疗有中度膝关节疼痛的膝骨关节炎患者:一项随机对照研究。

Liquid combination of hyaluronan, glucosamine, and chondroitin as a dietary supplement for knee osteoarthritis patients with moderate knee pain: A randomized controlled study.

机构信息

Institute of Medicine, China Medical University, Taichung and Department of Orthopaedics, China Medical University Hospital, Taichung, Taiwan.

Department of Ophthalmology, Taipei Municipal Wanfang Hospital, Taipei, Taiwan.

出版信息

Medicine (Baltimore). 2021 Oct 8;100(40):e27405. doi: 10.1097/MD.0000000000027405.

Abstract

BACKGROUND

Hyaluronan (HA), glucosamine, and chondroitin sulfate are widely consumed as dietary supplements for the treatment of knee osteoarthritis (OA). This study aimed to explore the efficacy and safety of a dietary liquid supplement mixture containing HA, glucosamine, and chondroitin in patients with knee OA who had moderate knee pain (visual analogue scale of 4-6 points).

METHODS

This was a short-term, randomized, double-blind, placebo-controlled study. Subjects were allocated to administer either a bottle of 20 mL supplement mixture (50 mg HA plus 750 mg glucosamine plus 250 mg chondroitin, namely A + HA) or placebo once daily for 8 weeks. Outcome measures included the Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, 36-item Short Form Survey (SF-36), Chinese version of Pittsburgh Sleep Quality Index, and incidence of adverse event were evaluated at the end of week 8. Efficacy analyses were conducted in the modified intent-to-treat population.

RESULTS

Of the 80 subjects in the modified intent-to-treat population, 39 received A + HA while 41 received placebo. After 8 weeks of treatment, the A + HA group failed to demonstrate a significant symptomatic efficacy and quality of life improvement in terms of Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, SF-36, and Chinese version of Pittsburgh Sleep Quality Index as compared to the placebo group. However, the mean changes in most of the SF-36 scale scores were numerically higher in the A + HA group than in the placebo group. No treatment-related adverse event was reported in both groups.

CONCLUSIONS

This present study found that the combination of liquid low molecular weight HA, glucosamine, and chondroitin oral supplement did not effectively improve knee OA pain and symptoms after short-term use in knee OA patients with moderate knee pain. However, these results should be interpreted with caution due to the intrinsic limitation of the study design.

摘要

背景

透明质酸(HA)、氨基葡萄糖和硫酸软骨素被广泛用作治疗膝骨关节炎(OA)的膳食补充剂。本研究旨在探讨含有 HA、氨基葡萄糖和硫酸软骨素的膳食液体补充混合物对中度膝关节疼痛(视觉模拟评分 4-6 分)的膝骨关节炎患者的疗效和安全性。

方法

这是一项短期、随机、双盲、安慰剂对照研究。受试者每天分配服用一瓶 20 毫升的补充混合物(50 毫克 HA 加 750 毫克氨基葡萄糖加 250 毫克硫酸软骨素,即 A+HA)或安慰剂,持续 8 周。在第 8 周末评估终点时,使用膝关节损伤和骨关节炎结果评分、西安大略和麦克马斯特大学骨关节炎指数、36 项简短形式调查(SF-36)、匹兹堡睡眠质量指数中文版和不良事件发生率进行评估。疗效分析在改良意向治疗人群中进行。

结果

在改良意向治疗人群中的 80 名受试者中,39 名接受了 A+HA,41 名接受了安慰剂。治疗 8 周后,与安慰剂组相比,A+HA 组在膝关节损伤和骨关节炎结果评分、西安大略和麦克马斯特大学骨关节炎指数、SF-36 和匹兹堡睡眠质量指数中文版方面未能表现出显著的症状疗效和生活质量改善。然而,与安慰剂组相比,A+HA 组大多数 SF-36 量表评分的平均变化数值更高。两组均未报告与治疗相关的不良事件。

结论

本研究发现,在中度膝关节疼痛的膝骨关节炎患者中,短期使用含有低分子质量 HA、氨基葡萄糖和硫酸软骨素的液体口服补充剂组合并未有效改善膝骨关节炎疼痛和症状。然而,由于研究设计的固有局限性,这些结果应谨慎解释。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b9b/8500584/8b04ecd563da/medi-100-e27405-g001.jpg

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