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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。
Objective To systematically evaluate the effect and safety of denosumab on lumbar spine bone mineral density in low bone mass women. Methods To search the clinical data of Medline, Embase, Cochrane Central Register of Controlled Cochrane Database, Wanfang Database, CNKI Full Text Database, and Chinese Biomedical Literature Database for the treatment of low bone mass women with denosumab, screening according to inclusion and exclusion criteria Out of randomized controlled trials, the quality of the studies included in the jadad scale was evaluated. Extract valid data and use RevMan 5.0.24 software for meta-analysis. Results A total of 5 double-blind, randomized controlled trials were performed and a meta-analysis using a fixed effect model showed that after 12 months of denosumab treatment, the increase in lumbar BMD was 5.45% (95% CI, 5.05% ~ 5.84%), P <0.00001. Serious adverse events, severe infections and low back pain occurred during the follow-up. Meta-analysis was performed using the fixed effect model with no significant difference between the two groups. Conclusion The denosumab relative to the placebo control group can significantly improve the lumbar spine bone mineral density, the safety of both approximation.