雷奈酸锶治疗原发性骨质疏松症有效性与安全性的Meta分析

A Meta-analysis of the efficacy and safety of strontium ranelate in the treatment of primary osteoporosis

目的对雷奈酸锶治疗原发性骨质疏松症的有效性与安全性进行Meta。方法通过PubMed、Embase、Cochrane library、CBM、CNKI、重庆维普、万方等中外数据库检索雷奈酸锶治疗骨质疏松的随机对照研究,随访时间至少12个月且至少提供骨密度或骨折数据文献纳入分析,评价文献方法学质量和提取数据后,采用RevMan 5.3进行Meta分析。结果共纳入5篇文献,涉及6802例骨质疏松症患者。与安慰剂相比,雷奈酸锶(2 g/d)的腰椎与髋部骨密度明显升高(腰椎:7.2%,95%CI(2.2%,12.3%),髋部:3.6%,95%CI(2.5%,4.7%)(P<0.05)),且降低椎体与非椎体骨折发生率(椎体骨折:OR 0.67,95%CI(0.48,0.93);非椎体骨折:OR 0.86,95%CI(0.74,0.99),(P<0.05))。与阿仑膦酸钠(70 mg/周)相比,雷奈酸锶(2 g/d)虽明显升高腰椎与髋部骨密度,但并不降低椎体与非椎体骨折发生率。雷奈酸锶(2 g/d)的总体不良事件与严重不良事件发生率与安慰剂或阿仑膦酸钠相比,无统计学差异(P>0.05)。结论雷奈酸锶增加骨质疏松症患者骨密度,降低骨折风险,且耐受性良好。

Objective To assess the efficacy and safety of strontium ranelate with primary osteoporosis patients.Methods Such databases as PubMed,Embase,Cochrane library,CBM,CNKI,WanFang,CQVIP,were electronically searched for randomized controlled trials on strontium ranelate and osteoporosis.According to the inclusion and exclusion criteria,literatures were screened,the methodological quality of included studies were also examined using the Cochrane risk of bias assessment tool and then data were extracted.Meta-analysis were then implemented using RevMan 5.3 software.Results Five studies involving 6802 subjects were included.The results of meta-analysis showed that compared with placebo,strontium ranelate(2g/d)significantly increased the lumbar spine and total hip bone mineral density(BMD)(lumbar spine:7.2%,95%CI(2.2%,12.3%),total hip:3.6%,95%CI(2.5%,4.7%),P<0.05),and decreased vertebral and non-vertebral fractures incidences(7.2%,95%CI(2.2%,12.3%),3.6%,95%CI(2.5%,4.7%),P<0.05).Additionally,compared with alendronate(70mg/w),strontium ranelate significantly increased the lumbar spine and total hip bone mineral density(BMD),but strontium ranelate did not decreased vertebral and non-vertebral fractures incidences.Total and serious adverse events were similar between strontium ranelate and placebo or alendronate.Conclusions Strontium ranelate markedly increased bone mineral density but decreased fracture risks with osteoporosis patients,and was well tolerated.