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每月口服 150 毫克伊班膦酸盐治疗绝经后骨质疏松症女性的疗效和安全性:系统评价和随机对照试验的荟萃分析。

Efficacy and safety of monthly 150 mg oral ibandronate in women with postmenopausal osteoporosis: a systematic review and meta-analysis of randomized controlled trials.

机构信息

Division of Rheumatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.

出版信息

Korean J Intern Med. 2011 Sep;26(3):340-7. doi: 10.3904/kjim.2011.26.3.340. Epub 2011 Sep 13.

DOI:10.3904/kjim.2011.26.3.340
PMID:22016595
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3192207/
Abstract

BACKGROUND/AIMS: The aim of this study was to assess the efficacy and safety of monthly oral 150 mg ibandronate in women with postmenopausal osteoporosis (PMO).

METHODS

A systematic review and meta-analysis were performed to determine treatment efficacy and safety outcomes between monthly oral 150 mg ibandronate and weekly 70 mg alendronate, daily 2.5 mg ibandronate, and a placebo.

RESULTS

Eight randomized controlled trials were included in this systematic review and meta-analysis. Once-monthly 150 mg ibandronate therapy was clinically comparable to weekly 70 mg alendronate, showing increased bone mineral density (BMD) in both the lumbar spine and total hip. Pooled data from two cross-over trials showed that significantly more women with PMO preferred once-monthly ibandronate therapy to once-weekly alendronate therapy (relative risk [RR], 2.422; 95% confidence interval [CI], 2.111 to 2.825; p < 1 × 10(-8)) and found the monthly ibandronate regimen more convenient than the weekly alendronate regimen (RR, 3.096; 95% CI, 2.622 to 3.622; p < 1 × 10(-8)). Monthly 150 mg ibandronate therapy resulted in a significantly higher change in BMD of the lumbar spine than with the placebo. A once monthly 150 mg regimen produced greater increases in lumbar spine, total hip, femoral neck, and trochanter BMD than daily treatment, with a similar incidence of adverse events between the groups.

CONCLUSIONS

Once monthly 150 mg ibandronate therapy was clinically comparable to weekly 70 mg alendronate, and patients strongly preferred the convenience of monthly ibandronate over weekly alendronate. Monthly 150 mg ibandronate was superior to, and as well tolerated as, the daily treatment.

摘要

背景/目的:本研究旨在评估每月口服 150mg 伊班膦酸盐治疗绝经后骨质疏松症(PMO)的疗效和安全性。

方法

系统评价和荟萃分析确定了每月口服 150mg 伊班膦酸盐与每周 70mg 阿仑膦酸盐、每日 2.5mg 伊班膦酸盐和安慰剂之间的治疗疗效和安全性结局。

结果

本系统评价和荟萃分析纳入了 8 项随机对照试验。每月 150mg 伊班膦酸盐治疗与每周 70mg 阿仑膦酸盐治疗在腰椎和全髋骨密度(BMD)方面具有临床可比性。两项交叉试验的汇总数据显示,更多患有 PMO 的女性更喜欢每月口服伊班膦酸盐治疗,而不是每周口服阿仑膦酸盐治疗(相对风险 [RR],2.422;95%置信区间 [CI],2.111 至 2.825;p<1×10(-8)),并且发现每月伊班膦酸盐方案比每周阿仑膦酸盐方案更方便(RR,3.096;95%CI,2.622 至 3.622;p<1×10(-8))。每月 150mg 伊班膦酸盐治疗可显著增加腰椎 BMD 的变化。与安慰剂相比,每月 150mg 伊班膦酸盐方案可使腰椎、全髋、股骨颈和转子 BMD 显著增加,且两组之间不良事件发生率相似。

结论

每月口服 150mg 伊班膦酸盐治疗与每周 70mg 阿仑膦酸盐具有临床可比性,且患者强烈倾向于每月伊班膦酸盐的便利性超过每周阿仑膦酸盐。每月 150mg 伊班膦酸盐优于且与每日治疗一样耐受。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f35d/3192207/d2ca6df9d619/kjim-26-340-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f35d/3192207/8bd679b6e1df/kjim-26-340-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f35d/3192207/0c48845cff48/kjim-26-340-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f35d/3192207/d2ca6df9d619/kjim-26-340-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f35d/3192207/8bd679b6e1df/kjim-26-340-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f35d/3192207/0c48845cff48/kjim-26-340-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f35d/3192207/d2ca6df9d619/kjim-26-340-g003.jpg

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