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双膦酸盐在股骨头坏死治疗中的应用:随机对照试验的荟萃分析

The use of bisphosphonate in the treatment of osteonecrosis of the femoral head: a meta-analysis of randomized control trials.

作者信息

Yuan H-F, Guo C-A, Yan Z-Q

机构信息

Department of Orthopedics, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Shanghai, 200043, China.

出版信息

Osteoporos Int. 2016 Jan;27(1):295-9. doi: 10.1007/s00198-015-3317-5. Epub 2015 Sep 14.

Abstract

UNLABELLED

This meta-analysis revealed that bisphosphonates could not provide a better clinical outcome in the treatment of osteonecrosis of the femoral head (ONFH) when compared with placebo.

INTRODUCTION

Bisphosphonates have been recommended to treat ONFH. However, the exact clinical outcomes after treatment are still controversial.

METHODS

A comprehensive search of PubMed, Embase, and Web of Science databases was undertaken, and only randomized control trials were included. The clinical outcomes consisted of progression to collapse, total hip arthroplasty (THA) incidence, and improvement of Harris hip score (HHS). The heterogeneities between the trials were assessed with the I (2) statistic, and random effects models were used for the meta-analysis.

RESULTS

Five eligible trials were identified involving 329 subjects with 920.9 patient-years of follow-up. The clinical outcomes of patients with ONFH was not significantly improved by bisphosphonate therapy (progression to collapse: risk ratio = 0.71 (0.41, 1.24), p = 0.23; THA incidence: risk ratio = 0.61 (0.33, 1.15), p = 0.13; HHS improvement: mean difference = 3.26 (-5.12, 11.64), p = 0.45). The I (2) statistic showed the existence of considerable heterogeneity (all I (2) ≥ 50 %), which was explained by one trial where bisphosphonate alone was used with no additional therapy. However, when this trial was excluded, the clinical outcomes after bisphosphonate therapy were still not significantly improved compared with placebo.

CONCLUSIONS

The current analysis does not support the use of bisphosphonates for ONFH. As potential serious adverse effects are associated with these drugs, only limited use can be recommended.

摘要

未标注

这项荟萃分析表明,与安慰剂相比,双膦酸盐在治疗股骨头坏死(ONFH)时并不能提供更好的临床疗效。

引言

双膦酸盐已被推荐用于治疗ONFH。然而,治疗后的确切临床疗效仍存在争议。

方法

对PubMed、Embase和Web of Science数据库进行全面检索,仅纳入随机对照试验。临床疗效包括塌陷进展、全髋关节置换术(THA)发生率以及Harris髋关节评分(HHS)的改善情况。采用I²统计量评估试验间的异质性,并使用随机效应模型进行荟萃分析。

结果

确定了5项符合条件的试验,涉及329名受试者,随访时间为920.9患者年。双膦酸盐治疗并未显著改善ONFH患者的临床疗效(塌陷进展:风险比=0.71(0.41,1.24),p=0.23;THA发生率:风险比=0.61(0.33,1.15),p=0.13;HHS改善:平均差值=3.26(-5.1,11.64),p=0.45)。I²统计量显示存在相当大的异质性(所有I²≥50%),这是由一项仅使用双膦酸盐且无额外治疗的试验所解释的。然而,当排除该试验后,与安慰剂相比,双膦酸盐治疗后的临床疗效仍未显著改善。

结论

目前的分析不支持使用双膦酸盐治疗ONFH。由于这些药物存在潜在的严重不良反应,仅建议有限使用。

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