南方医科大学学报 ›› 2013, Vol. 33 ›› Issue (06): 913-.

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狄诺塞麦对低骨量妇女腰椎骨密度的影响及其安全性的meta分析

朱晓文,陈建庭   

  • 出版日期:2013-06-20 发布日期:2013-06-20

The influence and safety of denosumab on bone mineral density of lumbar spine in women with low bone mass: a meta-analysis

  • Online:2013-06-20 Published:2013-06-20

摘要: 目的系统评价狄诺塞麦对低骨量妇女腰椎骨密度的影响及其安全性。方法检索Medline 数据库、Embase 数据库、
Cochrane临床对照实验中心数据库、万方数据库、中国知网全文数据库、中国生物医学文献数据库有关狄诺塞麦治疗低骨量妇
女的临床研究,按照纳入及排除标准筛选出随机对照试验,用jadad 量表对纳入的研究进行质量评价。提取有效数据,采用
RevMan 5.0.24软件进行meta分析。结果共纳入双盲、随机对照试验5项,采用固定效应模型进行meta分析,结果示狄诺塞麦
治疗12月后,腰椎骨密度升高幅度比安慰剂对照试验高5.45%(95% CI,5.05%~5.84%),P<0.00001。对随访期间发生的严重
不良事件、严重感染事件及腰背痛事件,采用固定效应模型进行meta分析,两组间并无显著差异。结论狄诺塞麦组相对安慰剂
对照组可显著提高腰椎骨密度,两者的安全性近似。

Abstract: Objective To evaluate the influence and safety of denosumab on bone mineral density(BMD) of lumbar spine in
women with low bone mass. Methods The clinical literatures concerning denosumab for the treatment of osteopenia or
osteoporosis in women were searched from Medline, Embase, Cochrane Central Register of Controlled Trials, Wanfang
database, China National Knowledge Infrastructure database, Chinese Biomedical Database. Randomized controlled trials
(RCT) were selected by the inclusive and exclusive criteria. The jadad scale was used in the quality assessment of included
studies. Meta-analysis of valid data picked from included studies was performed by RevMan 5.0.24 software. Results 5 RCT
were included in this meta-analysis. The results of meta-analysis using the fixed effects model showed that, the increase level
of lumbar BMD after 12 month was 5.45% (95% CI, 5.05%~5.84%) higher in denosumab group than in placebo control group(P<
0.00001). The serious adverse event, serious infection event and pack pain occurred during the followed-up were analysed
using fixed effects model. The results showed no significant difference between two groups. Conclusions Compared with
placebo control group, denosumab can significant increase the BMD of lumbar spine, and the safety of two groups is similar.