狄诺塞麦和双膦酸盐治疗绝经后妇女骨质疏松症效果及安全性的Meta分析

Efficacy and safety evaluation of denosumab and bisphosphonate on the treatment of osteoporosis in postmenopausal women:a meta-analysis

目的系统评价狄诺塞麦与双膦酸盐治疗绝经后妇女骨质疏松症(osteoporosis,OP)的疗效及安全性的差异。方法在以下几个数据库进行检索:中国生物医学文献数据库CBM、Embase、PubMED、CNKI、维普数据库以及Cochrane临床对照实验中心数据库,获得狄诺塞麦与双膦酸盐对妇女绝经后OP治疗的临床研究,依据纳入与排除标准获得随机对照试验文献,使用"Cochrane协作网的偏倚评价标准"评估纳入文献质量。获得所需数据,应用RevMan 5.3软件进行Meta分析。结果共获得符合条件的文献9篇,结果显示患有骨质疏松症的绝经后妇女治疗1年后,狄诺塞麦组腰椎、髋部及股骨颈骨密度升高幅度比双膦酸盐组分别高1.42%(95%CI:0.93%~1.90%,P<0.00001)、1.11%(95%CI:0.97%~1.25%,P<0.00001)及1.01%(95%CI:0.81%~1.22%,P<0.00001)。狄诺塞麦组不良反应事件、严重不良反应事件、骨折及死亡的发生率和双膦酸盐组相似,差异无统计学意义;狄诺塞麦组因不良反应导致的患者退出率低于双膦酸盐组,差异具有显著的统计学意义。结论相比双膦酸盐,狄诺塞麦可明显提升绝经后OP妇女的髋部、腰椎、股骨颈等处的骨密度,而安全性,两者相似。

Objective Differences in efficacy and safety evaluation system for the treatment of osteoporosis denosumab and bisphosphonates in postmenopausal women. Methods Search in the following databases：Chinese biomedical literature database,EMBASE,PubMed,CNKI,VIP database and clinical laboratory center database,obtain denosumab and bisphosphonates on clinical study of treatment of OP in postmenopausal women,according to the inclusion and exclusion criteria for randomized controlled trial,to evaluate the quality of the included studies using the ＂bias evaluation standard＂ Cochrane collaboration. Get the required data,using Revman 5.3 software for data analysis meta. Results 9 RCT were included in this meta-analysis. The results showed that after one year treatment,the increase level of lumbar spine,total hip and femoral neck bone mineral density （BMD） in postmenopausal women was 1.42% （95% CI：0.93%-1.90% ,P〈0.00001 ）, 1.11% （95% CI：0.97%-1.25%,P〈0.00001 ） and 1.01% （95% CI：0.81%-1.22% ,P〈0.00001） higher in denosumab group than in bisphosphonate group, respectively. There was no statistically significant difference between patients receiving denosumab and those receiving bisphosphonate in terms of adverse events,serious adverse events,fracture and deaths. Withdrawals due to adverse events were less frequent in denosumab than in bisphosphonate group and the difference reached statistical significance. Conclusion Compared with bisphosphonates,bone density of hip,lumbar spine and femoral neck at denosumab group significantly improved in postmenopausal women with OP, and the safety of both is similar.