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骨关节炎患者膝关节关节间隙宽度的下降率:硫酸软骨素随机安慰剂对照试验的系统评价和荟萃分析。

The rate of decline of joint space width in patients with osteoarthritis of the knee: a systematic review and meta-analysis of randomized placebo-controlled trials of chondroitin sulfate .

机构信息

University of Maryland School of Medicine, Baltimore, MD, USA.

出版信息

Curr Med Res Opin. 2008 Nov;24(11):3029-35. doi: 10.1185/03007990802434932. Epub 2008 Oct 2.

Abstract

BACKGROUND

Chondroitin sulfate has been shown to relieve pain and improve functional limitation in patients with osteoarthritis (OA) of the knee in numerous clinical trials and meta-analyses. Its role as a potential structure-modifying drug for knee OA, however, remains controversial.

OBJECTIVE

To perform a meta-analysis of randomized double-blind placebo-controlled clinical trials to assess the efficacy of chondroitin sulfate as a structure-modifying drug for knee OA.

RESEARCH DESIGN AND METHODS

A Medline search was conducted from 1996 through 2007 and five articles that reported results from three trials were identified; one additional trial was identified through review of presentations at annual rheumatology meetings. There was no evidence of heterogeneity across the trials and results were pooled using a fixed effects meta-analysis.

RESULTS

Pooled results demonstrated a small significant effect of chondroitin sulfate on the reduction in rate of decline in minimum joint space width of 0.07 mm/year (95% CI 0.03, 0.10) that corresponded to an effect size of 0.26 (95% CI 0.14, 0.38) (p < 0.0001). This result was robust in sensitivity analyses.

LIMITATIONS

The individual studies included in the meta-analysis varied in the number of patients enrolled and the techniques used to acquire knee radiographs and to measure joint space width.

CONCLUSION

These results demonstrate that chondroitin sulfate is effective for reducing the rate of decline in minimum joint space width in patients with OA of the knee. Chondroitin sulfate may have a role as a structure-modifying agent in the management of patients with knee OA.

摘要

背景

硫酸软骨素在多项临床试验和荟萃分析中已被证明可缓解膝骨关节炎(OA)患者的疼痛并改善其功能受限。然而,其作为膝 OA 的潜在结构修饰药物的作用仍存在争议。

目的

进行一项随机双盲安慰剂对照临床试验的荟萃分析,以评估硫酸软骨素作为膝 OA 结构修饰药物的疗效。

研究设计和方法

对 1996 年至 2007 年的 Medline 进行了检索,确定了 5 篇报告了 3 项试验结果的文章;通过审查年度风湿病会议的演讲,又确定了 1 项额外的试验。这些试验之间没有异质性证据,结果使用固定效应荟萃分析进行汇总。

结果

汇总结果表明,硫酸软骨素对最小关节间隙宽度下降速度的降低有较小的显著影响,平均每年减少 0.07mm(95%CI 0.03, 0.10),相当于效应大小为 0.26(95%CI 0.14, 0.38)(p<0.0001)。该结果在敏感性分析中是稳健的。

局限性

荟萃分析中纳入的个别研究在纳入患者的数量、获得膝关节 X 线片和测量关节间隙宽度的技术方面存在差异。

结论

这些结果表明,硫酸软骨素可有效降低膝骨关节炎患者最小关节间隙宽度的下降速度。硫酸软骨素可能在膝骨关节炎患者的管理中具有结构修饰剂的作用。

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