阿仑膦酸钠治疗男性骨质疏松症：随机对照试验的荟萃分析

Alendronate for the Treatment of Osteoporosis in Men: A Meta-Analysis of Randomized Controlled Trials.

作者信息

Xu Zhiguo

机构信息

Department of Orthopaedics, Central Hospital of Zaozhuang Mining Group, Zaozhuang, China.

出版信息

Am J Ther. 2017 Mar/Apr;24(2):e130-e138. doi: 10.1097/MJT.0000000000000446.

DOI:10.1097/MJT.0000000000000446

PMID:27058577

Abstract

BACKGROUND

Alendronate has been widely used in the treatment of osteoporosis. However, the effect of alendronate in the male osteoporosis remains controversial.

STUDY QUESTION

We conducted a meta-analysis to assess the efficacy of alendronate in the treatment of men with osteoporosis.

STUDY DESIGN

PubMed, Embase, and Web of Science were searched from their inception to October 25, 2015. Eligible studies were randomized controlled trials that evaluated the effect of alendronate in the male osteoporosis.

MEASURES AND OUTCOMES

The outcomes included mean percentage changes in bone mineral density (BMD) of lumbar spine, femoral neck, total hip, trochanter, and total body, and the incidence of new vertebral fractures. Results were expressed with weighted mean difference (WMD), and risk ratio with 95% CIs. A fixed-effects model or random-effects model was used for the meta-analysis according to heterogeneity.

RESULTS

Eight studies involving 988 patients met the inclusion criteria. Alendronate significantly increased the mean percentage BMD at the lumbar spine (WMD = 4.95, 95% CI, 2.40-7.49; P < 0.001), femoral neck (WMD = 2.59, 95% CI, 1.52-3.66; P < 0.001), and total hip (WMD = 2.39, 95% CI, 1.05-3.27; P < 0.001), but not at the trochanter (WMD = 1.76, 95% CI, -0.69 to 4.21; P = 0.158) and total body (WMD = 3.29, 95% CI, -0.04 to 6.62; P = 0.053). Moreover, alendronate was also decreased the incidence of vertebral fractures (risk ratio = 0.46, 95% CI, 0.28-0.77; P = 0.003). Subgroup analysis showed that among the male osteoporosis, greater increase in the lumbar spine BMD (WMD = 5.99, 95% CI, 3.42-8.56; P < 0.001) and femoral neck BMD (WMD = 3.66, 95% CI, 2.57-4.76; P = 0.023) was observed when the alendronate was administrated with a dose of 10 mg.

CONCLUSION

Based on current evidence, alendronate shows beneficial effect on the lumbar spine, femoral neck, and total hip BMD, and the incidence of new vertebral fractures.

摘要

背景

阿仑膦酸钠已广泛用于骨质疏松症的治疗。然而，阿仑膦酸钠在男性骨质疏松症治疗中的效果仍存在争议。

研究问题

我们进行了一项荟萃分析，以评估阿仑膦酸钠治疗男性骨质疏松症的疗效。

研究设计

检索了PubMed、Embase和Web of Science自创建至2015年10月25日的文献。符合条件的研究为评估阿仑膦酸钠对男性骨质疏松症疗效的随机对照试验。

测量指标与结果

结果包括腰椎、股骨颈、全髋、大转子和全身骨密度（BMD）的平均百分比变化以及新发椎体骨折的发生率。结果以加权均数差（WMD）和95%可信区间的风险比表示。根据异质性采用固定效应模型或随机效应模型进行荟萃分析。

结果

八项涉及988例患者的研究符合纳入标准。阿仑膦酸钠显著提高了腰椎（WMD = 4.95，95%可信区间，2.40 - 7.49；P < 0.001）、股骨颈（WMD = 2.59，95%可信区间，1.52 - 3.66；P < 0.001）和全髋（WMD = 2.39，95%可信区间，1.05 - 3.27；P < 0.001）的BMD平均百分比，但大转子（WMD = 1.76，95%可信区间，-0.69至4.21；P = 0.158）和全身（WMD = 3.29，95%可信区间，-0.04至6.62；P = 0.053）未显著提高。此外，阿仑膦酸钠还降低了椎体骨折的发生率（风险比 = 0.46，95%可信区间，0.28 - 0.77；P = 0.003）。亚组分析显示，在男性骨质疏松症患者中，当阿仑膦酸钠剂量为10 mg时，腰椎BMD（WMD = 5.99，95%可信区间，3.42 - 8.56；P < 0.001）和股骨颈BMD（WMD = 3.66，95%可信区间，2.57 - 4.76；P = 0.023）有更大幅度的增加。