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密蒙花提取物治疗膝骨关节炎患者的疗效和安全性。

Efficacy and safety of Derris scandens Benth extracts in patients with knee osteoarthritis.

机构信息

Department of Rehabilitation Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

J Altern Complement Med. 2011 Feb;17(2):147-53. doi: 10.1089/acm.2010.0213. Epub 2011 Feb 10.

Abstract

OBJECTIVES

The objectives of this study were to determine the efficacy and safety of Derris scandens Benth extracts in pain reduction and functional improvement in patients with knee osteoarthritis (OA).

DESIGN

This was a prospective, randomized, controlled trial, single-blinded (assessor).

SETTINGS

The study was conducted at the Rehabilitation Medicine Department, Siriraj Hospital.

SUBJECTS

One hundred and seven (107) patients with primary OA knee who had pain score of ≥ 5 were recruited.

INTERVENTIONS

Patients were randomized to receive naproxen 500 mg/day or Derris 800 mg/day for 4 weeks.

OUTCOME MEASUREMENTS

Western Ontario McMaster Osteoarthritis Index (WOMAC) scores and 6-minute walking distance were the outcome measurements.

RESULTS

Fifty-five (55) and 52 patients were randomized to Derris and naproxen groups, respectively. The mean differences of all WOMAC scores between 2 groups at week 4 adjusted by week 0 were within ± 1 point. The mean scores of the aforementioned outcomes at weeks 0, 2, and 4 were significantly improved compared to the baseline values. There was no difference of WOMAC scores between groups. The gastrointestinal irritation and dyspepsia were observed more often in the naproxen than in the Derris group.

CONCLUSIONS

Derris scandens Benth extracts were efficacious and safe for the treatment of knee OA.

摘要

目的

本研究旨在确定鱼藤酮提取物在减轻膝关节骨关节炎(OA)患者疼痛和改善功能方面的疗效和安全性。

设计

这是一项前瞻性、随机、对照、单盲(评估者)试验。

地点

本研究在 Siriraj 医院康复医学系进行。

受试者

共招募了 107 名膝关节原发性 OA 疼痛评分≥5 的患者。

干预措施

患者随机接受萘普生 500mg/天或鱼藤酮 800mg/天治疗 4 周。

测量结果

采用 Western Ontario McMaster Osteoarthritis Index(WOMAC)评分和 6 分钟步行距离作为测量结果。

结果

55 例和 52 例患者分别随机分配到鱼藤酮组和萘普生组。调整基线后,两组在第 4 周时所有 WOMAC 评分的平均差值均在±1 分以内。与基线值相比,上述结局在第 0、2 和 4 周的平均评分均显著改善。两组间 WOMAC 评分无差异。萘普生组比鱼藤酮组更常出现胃肠道刺激和消化不良。

结论

鱼藤酮提取物对治疗膝骨关节炎有效且安全。

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