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依屈膦酸钠治疗骨质疏松症的疗效和安全性:一项随机对照试验的系统评价和荟萃分析。

The efficacy and safety of menatetrenone in the management of osteoporosis: a systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Pharmacy, Peking University Third Hospital, 49 Huayuan North Road, Haidian District, Beijing, 100191, China.

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Science, Peking University, Beijing, China.

出版信息

Osteoporos Int. 2019 Jun;30(6):1175-1186. doi: 10.1007/s00198-019-04853-7. Epub 2019 Feb 7.

DOI:10.1007/s00198-019-04853-7
PMID:30734066
Abstract

UNLABELLED

In our systematic review and meta-analysis, we comprehensively evaluated menatetrenone in the management of osteoporosis. We found that menatetrenone decreased the ratio of undercarboxylated osteocalcin to osteocalcin (ucOC/OC) and improved lumbar BMD compared with placebo based on the 18 studies assessed. However, its benefit in fracture risk control was uncertain.

INTRODUCTION

We performed a systematic review and meta-analysis of the efficacy and safety of menatetrenone in managing osteoporosis.

METHODS

PubMed, Cochrane Library, Embase, ClinicalTrials.gov , and three Chinese literature databases (CNKI, CBM, Wanfang) were searched for relevant randomized controlled trials (RCTs) published before October 5, 2017, comparing menatetrenone with other anti-osteoporotic drugs or placebo in treating osteoporosis. The pooled risk ratio (RR) or mean difference (MD) and 95% confidence interval (CI) were calculated using fixed-effects or random-effects meta-analysis.

RESULTS

Eighteen RCTs (8882 patients) were included. Pooled analyses showed that menatetrenone was more effective than placebo in improving lumbar bone mineral density (BMD) (five studies, N = 658, MD = 0.05 g/cm, 95% CI 0.01 to 0.09 g/cm) and decreasing ucOC/OC (two studies, N = 75, MD = - 21.78%, 95% CI - 33.68 to - 9.87%). Compared with placebo, menatetrenone was associated with a nonsignificantly decreased risk of vertebral fracture (five studies, N = 5508, RR = 0.87, 95% CI 0.64 to 1.20). Evidence on other anti-osteoporotic drugs as comparators was limited and revealed no significantly different effects of menatetrenone on BMD or fracture risks. Furthermore, compared with placebo, menatetrenone significantly increased the incidence of adverse events (AEs) (two studies, N = 1949, RR = 1.47, 95% CI 1.07 to 2.02) and adverse drug reactions (four studies, N = 6102, RR = 1.29, 95% CI 1.07 to 1.56). However, no significant difference in the incidence of serious AEs was found between menatetrenone and placebo.

CONCLUSIONS

Menatetrenone significantly decreases ucOC and might improve lumbar BMD in osteoporotic patients. However, its benefit in fracture risk control is uncertain.

摘要

目的

我们对 menatetrenone 治疗骨质疏松症的疗效和安全性进行了系统评价和荟萃分析。

方法

检索了PubMed、Cochrane Library、Embase、ClinicalTrials.gov 和三个中文文献数据库(CNKI、CBM、万方),以获取截至 2017 年 10 月 5 日比较 menatetrenone 与其他抗骨质疏松药物或安慰剂治疗骨质疏松症的随机对照试验(RCT)。使用固定效应或随机效应荟萃分析计算合并风险比(RR)或均数差值(MD)和 95%置信区间(CI)。

结果

纳入了 18 项 RCT(8882 例患者)。荟萃分析结果显示,与安慰剂相比,menatetrenone 更能有效改善腰椎骨密度(BMD)(5 项研究,N=658,MD=0.05 g/cm,95%CI 0.01 至 0.09 g/cm)和降低 uOC/OC(2 项研究,N=75,MD=-21.78%,95%CI-33.68 至-9.87%)。与安慰剂相比,menatetrenone 与椎体骨折风险降低无显著相关性(5 项研究,N=5508,RR=0.87,95%CI 0.64 至 1.20)。对于其他抗骨质疏松药物的对照研究证据有限,未显示 menatetrenone 对 BMD 或骨折风险有显著不同的影响。此外,与安慰剂相比,menatetrenone 显著增加了不良反应(AE)的发生率(2 项研究,N=1949,RR=1.47,95%CI 1.07 至 2.02)和药物不良反应(DRAs)(4 项研究,N=6102,RR=1.29,95%CI 1.07 至 1.56)。然而,menatetrenone 与安慰剂之间严重不良事件的发生率无显著差异。

结论

menatetrenone 可显著降低 uOC,可能改善骨质疏松症患者的腰椎 BMD,但对骨折风险控制的益处尚不确定。

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