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Movardol®(N-乙酰葡糖胺、锯叶棕、生姜)补充剂用于膝关节骨关节炎的管理:一项为期6个月的注册研究的初步结果。

Movardol® (N-acetylglucosamine, Boswellia serrata, ginger) supplementation in the management of knee osteoarthritis: preliminary results from a 6-month registry study.

作者信息

Bolognesi G, Belcaro G, Feragalli B, Cornelli U, Cotellese R, Hu S, Dugall M

机构信息

Leonardo Medica srl, Vinci, Florence, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2016 Dec;20(24):5198-5204.

Abstract

OBJECTIVE

Knee Osteoarthritis (OA) is a chronic disease caused by the deterioration of cartilage in joints, which results in activation of the inflammatory response, pain, and impaired movement. Complementary therapies, particularly supplementation, in the management of moderate/severe knee OA have been gaining attention. This registry study aimed at evaluating the synergistic effect of Movardol®, a supplementation containing active ingredients with recognized anti-inflammatory activities on symptoms and levels of circulating biomarkers of knee OA.

PATIENTS AND METHODS

54 subjects with symptomatic, moderate knee OA freely decided to follow either a standard management (SM) (n = 26) or SM plus oral supplementation with Movardol® (n = 28). Movardol® supplementation containing N-acetyl-D-glucosamine, ginger, and Boswellia Serrata extract was taken at the following dosage: 3 tablets/day for one week and then 2 tablets/day. Several parameters were assessed at inclusion and after 1, 3 and 6 months: functional impairment by the Karnofsky Performance Scale Index; pain, stiffness, physical, social and emotional functions by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); total and pain-free walking distance; circulating biomarkers of inflammation and oxidative stress.

RESULTS

Significant improvements in the functional outcomes and pain-free walking distance were observed after 1, 3 and 6 months in OA patients supplemented with Movardol®. Moreover, all the signs/symptoms of disease assessed by the WOMAC tended to regress over a 6-month period in patients following SM+supplementation. Inflammatory markers and plasmatic content of reactive oxygen species decreased over 6 months, in supplemented patients. Movardol® supplementation resulted to be safe and well tolerated, also showing the beneficial effect in term of a decrease in pharmacological and non-pharmacological treatments and, consequently, reduction in management costs.

CONCLUSIONS

These preliminary results indicate the efficacy and safety of Movardol® supplementation in the management of moderate knee OA.

摘要

目的

膝关节骨关节炎(OA)是一种由关节软骨退变引起的慢性疾病,会导致炎症反应激活、疼痛和运动功能受损。辅助疗法,尤其是补充剂,在中重度膝关节OA的管理中越来越受到关注。本登记研究旨在评估Movardol®(一种含有具有公认抗炎活性成分的补充剂)对膝关节OA症状和循环生物标志物水平的协同作用。

患者与方法

54例有症状的中度膝关节OA患者自由决定接受标准治疗(SM)(n = 26)或SM加口服Movardol®补充剂(n = 28)。含有N-乙酰-D-葡萄糖胺、生姜和乳香提取物的Movardol®补充剂服用剂量如下:每天3片,服用一周,然后每天2片。在纳入时以及1、3和6个月后评估了几个参数:通过卡诺夫斯基表现量表指数评估功能损害;通过西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评估疼痛、僵硬、身体、社会和情感功能;总步行距离和无痛步行距离;炎症和氧化应激的循环生物标志物。

结果

补充Movardol®的OA患者在1、3和6个月后,功能结局和无痛步行距离有显著改善。此外,在接受SM+补充剂治疗的患者中,通过WOMAC评估的所有疾病体征/症状在6个月内趋于消退。补充剂治疗的患者在6个月内炎症标志物和活性氧的血浆含量下降。Movardol®补充剂被证明是安全且耐受性良好的,还显示出在减少药物和非药物治疗方面的有益效果,从而降低了管理成本。

结论

这些初步结果表明Movardol®补充剂在中度膝关节OA管理中的有效性和安全性。

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