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氨基葡萄糖、硫酸软骨素、二者联合、塞来昔布或安慰剂治疗膝关节骨关节炎的临床疗效和安全性:GAIT 的 2 年结果。

Clinical efficacy and safety of glucosamine, chondroitin sulphate, their combination, celecoxib or placebo taken to treat osteoarthritis of the knee: 2-year results from GAIT.

机构信息

University of Utah School of Medicine, 30E 1900 S SOM 4B200, Salt Lake City UT 84132, USA.

出版信息

Ann Rheum Dis. 2010 Aug;69(8):1459-64. doi: 10.1136/ard.2009.120469. Epub 2010 Jun 4.

Abstract

BACKGROUND

Knee osteoarthritis (OA) is a major cause of pain and functional limitation in older adults, yet longer-term studies of medical treatment of OA are limited.

OBJECTIVE

To evaluate the efficacy and safety of glucosamine and chondroitin sulphate (CS), alone or in combination, as well as celecoxib and placebo on painful knee OA over 2 years.

METHODS

A 24-month, double-blind, placebo-controlled study, conducted at nine sites in the US ancillary to the Glucosamine/chondroitin Arthritis Intervention Trial, enrolled 662 patients with knee OA who satisfied radiographic criteria (Kellgren/Lawrence grade 2 or 3 changes and baseline joint space width of at least 2 mm). This subset continued to receive their randomised treatment: glucosamine 500 mg three times daily, CS 400 mg three times daily, the combination of glucosamine and CS, celecoxib 200 mg daily, or placebo over 24 months. The primary outcome was a 20% reduction in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain over 24 months. Secondary outcomes included an Outcome Measures in Rheumatology/Osteoarthritis Research Society International response and change from baseline in WOMAC pain and function.

RESULTS

Compared with placebo, the odds of achieving a 20% reduction in WOMAC pain were celecoxib: 1.21, glucosamine: 1.16, combination glucosamine/CS: 0.83 and CS alone: 0.69, and were not statistically significant.

CONCLUSIONS

Over 2 years, no treatment achieved a clinically important difference in WOMAC pain or function as compared with placebo. However, glucosamine and celecoxib showed beneficial but not significant trends. Adverse reactions were similar among treatment groups and serious adverse events were rare for all treatments.

摘要

背景

膝骨关节炎(OA)是老年人疼痛和功能受限的主要原因,但对 OA 医学治疗的长期研究有限。

目的

评估氨基葡萄糖和硫酸软骨素(CS)单独或联合使用,以及塞来昔布和安慰剂在 2 年内对膝关节 OA 疼痛的疗效和安全性。

方法

这是一项为期 24 个月的、在美国 9 个地点进行的、双盲、安慰剂对照的辅助研究,纳入了 662 名符合放射学标准(Kellgren/Lawrence 分级 2 或 3 级改变,基线关节间隙宽度至少 2 毫米)的膝关节 OA 患者。这部分患者继续接受随机治疗:氨基葡萄糖 500mg,每日 3 次;CS 400mg,每日 3 次;氨基葡萄糖和 CS 的联合治疗;塞来昔布 200mg,每日 1 次;或安慰剂,持续 24 个月。主要终点是 24 个月时 Western Ontario 和 McMaster 大学骨关节炎指数(WOMAC)疼痛评分降低 20%。次要终点包括反应测量和风湿病学/骨关节炎研究协会国际(OMERACT)的变化,以及 WOMAC 疼痛和功能的基线变化。

结果

与安慰剂相比,WOMAC 疼痛评分降低 20%的可能性是塞来昔布:1.21,氨基葡萄糖:1.16,联合使用氨基葡萄糖/CS:0.83,CS 单独使用:0.69,且均无统计学意义。

结论

在 2 年内,与安慰剂相比,没有任何治疗在 WOMAC 疼痛或功能方面达到了临床重要差异。然而,氨基葡萄糖和塞来昔布显示出有益但无统计学意义的趋势。治疗组之间的不良反应相似,所有治疗的严重不良事件均罕见。

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