奥达卡替治疗绝经后妇女骨质疏松症的疗效及安全性的Meta分析

Efficacy and safety of odanacatib in the treatment of osteoporosis of postmenopausal women:a meta-analysis

目的系统评价奥达卡替治疗绝经后妇女骨质疏松症的疗效及安全性。方法检索Cochrane临床对照实验中心数据库、Pub MED、Embase、中国生物医学文献数据库、中国知网全文数据库和维普数据库中奥达卡替治疗绝经后妇女骨质疏松症的临床研究,按照纳入及排除标准筛选出随机对照试验,采用"Cochrane协作网的偏倚评价标准"来对纳入文献进行质量评价。提取有效数据,采用Rev Man 5.3软件进行Meta分析。结果共纳入双盲、随机对照试验4项,结果显示奥达卡替治疗12个月后,腰椎及股骨颈骨密度升高幅度比安慰剂对照组分别高3.3%(95%CI:1.6%~4.99%,P=0.0001)、2.03%(95%CI:1.09%~2.96%,P<0.0001),血清中1型胶原C端肽及尿N-端肽降低幅度比安慰剂对照组分别高48.24%(95%CI:-65.56%^-30.92%,P<0.0001)、52.26%(95%CI:-61.28%^-43.24%,P<0.00001)。对随访期间发生的严重不良事件及皮肤不良反应事件,采用固定效应模型进行Meta分析,两组间并无显著差异(P>0.05)。结论奥达卡替组相对安慰剂对照组可显著提高腰椎及股骨颈骨密度,降低血清中1型胶原C端肽及尿N-端肽浓度,两者的安全性近似。

Objective To evaluate the efficacy and safety of odanacatib （ODN） in the treatment of osteoporosis in postmenopausal women. Methods The clinical literatures concerning ODN for the treatment of osteoporosis in postmenopausal women were searched from Cochrane Central Register of Controlled Trials, PubMED,Embase,Chinese Biomedical Database,China National Knowledge Infrastructure database,WeiPu database. Randomized controlled trials （RCT） were selected by the inclusive and exclusive criteria. Cochrane collaboration＇s tool was used in the quality assessment of included studies. Meta-analysis of valid data picked from included studies was performed by RevMan 5.3 software. Results The 4 RCT were included in this meta-analysis,which showed that the increase level of lumbar and femoral neck bone mineral density （BMD） after 12 month was 3.3% （95% CI：1.6%-4.99%,P=0.0001） and 2.03%（95% CI：1.09%-2.96% ,P〈0.0001） higher in ODN group than in placebo control group,respectively, the declining level of serum C-telopeptides of type 1 collagen （sCTx） and urinary N-telopeptides of type 1 collagen （uNTx） after 12 month was 48.24%（95% CI：-65.56%--30.92%,P〈 0.0001） and 52.26%（95% CI：-61.28%--43.24%,P〈0.00001）higher in ODN group than in placebo control group, respectively. The serious adverse event and skin adverse event occurred during the followed-up duration were analysed using fixed effects model. The results showed no significant difference between two groups （P〉0.05）. Conclusion Compared with placebo control group,ODN can significant increase the BMD of lumbar spine and femoral neck,reduce concentration of sCTx and uNTx,the safety of two groups is similar.