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口服双膦酸盐预防日本神经疾病残疾患者髋部骨折的疗效:一项随机对照试验的荟萃分析。

Efficacy of oral bisphosphonates for preventing hip fracture in disabled patients with neurological diseases: a meta-analysis of randomized controlled trials among the Japanese population.

机构信息

Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan.

出版信息

Curr Med Res Opin. 2011 Jun;27(6):1141-8. doi: 10.1185/03007995.2011.570747. Epub 2011 Apr 1.

Abstract

OBJECTIVE

Neurological diseases such as amyotrophic lateral sclerosis (ALS), stroke, and Parkinson's disease cause disability and immobilization that increases the risk of hip fracture. The purpose of the present study was to clarify the efficacy of oral bisphosphonates for preventing hip fracture in disabled patients with such neurological diseases.

METHODS

A literature search (PubMed) was done from 1995 to the present for randomized controlled trials (RCTs), and a meta-analysis was conducted.

RESULTS

Seven RCTs met the criteria, including two of etidronate (ALS and stroke), two of alendronate (stroke and Parkinson's disease), and three of risedronate (stroke and Parkinson's disease). All of the RCTs were performed on Japanese patients. According to the results of pooled data analysis, the relative risk (95% confidence interval) of hip fracture in patients receiving etidronate, alendronate, and risedronate treatment compared with placebo or active control treatment was 0.16 (0.03-0.87), 0.29 (0.10-0.80), and 0.24 (0.10-0.58), respectively, suggesting a reduction of risk by more than 70% with oral bisphosphonates. There was no statistical evidence of heterogeneity among RCTs, and publication bias was not identified by the funnel plot and Begg's rank correlation test. No severe adverse events due to oral bisphosphonate treatment were reported.

LIMITATION

It remains uncertain whether the findings are relevant for Western patients with an increased risk of hip fracture due to neurological diseases.

CONCLUSION

A meta-analysis of RCTs suggested that oral bisphosphonate treatment prevents hip fracture in disabled Japanese patients with neurological diseases, including ALS, stroke, and Parkinson's disease. Oral bisphosphonate treatment was well tolerated by such patients.

摘要

目的

肌萎缩侧索硬化症(ALS)、中风和帕金森病等神经系统疾病可导致残疾和瘫痪,从而增加髋部骨折的风险。本研究旨在阐明口服双膦酸盐预防此类神经疾病所致失能患者髋部骨折的疗效。

方法

检索 1995 年至目前的 PubMed 文献,纳入随机对照试验(RCT),并进行荟萃分析。

结果

7 项 RCT 符合纳入标准,包括依替膦酸二钠(ALS 和中风)、阿仑膦酸钠(中风和帕金森病)各 2 项,利塞膦酸钠(中风和帕金森病)3 项。所有 RCT 均在日本患者中进行。汇总数据分析结果显示,与安慰剂或活性对照治疗相比,接受依替膦酸二钠、阿仑膦酸钠和利塞膦酸钠治疗的患者髋部骨折的相对风险(95%置信区间)分别为 0.16(0.03-0.87)、0.29(0.10-0.80)和 0.24(0.10-0.58),提示口服双膦酸盐可降低 70%以上的风险。各 RCT 间无统计学异质性,漏斗图和 Begg 秩相关检验未发现发表偏倚。未报告因口服双膦酸盐治疗而出现严重不良事件。

局限性

尚不确定这些发现对于因神经系统疾病而髋部骨折风险增加的西方患者是否相关。

结论

RCT 的荟萃分析提示,口服双膦酸盐预防神经疾病所致失能日本患者髋部骨折,包括 ALS、中风和帕金森病。此类患者对口服双膦酸盐治疗耐受良好。

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