特立帕肽与阿仑膦酸盐对比治疗骨质疏松症有效性及安全性的Meta分析

摘要

Objective To evaluate the difference of efficacy and safety between teriparatide and alendronate for the treatment of osteoporosis. Methods A meta-analysis. The clinical literatures concerning teriparatide and alendronate for the treatment of osteoporosis were searched from Medline ( 1966-2011) , Embase ( 1966-2010) , the Cochrane Library (2010) , and CBM (1979-2010) database, according to Cochrane evaluation guidelines. The subjects were chosen according to the inclusive and exclusive criteria. Qualities of literatures were evaluated by Jadad score. The meta-analysis was performed by RevMan 4. 2 statistical software offered by Cochrane collaboration net to obtain the relative evidences of efficacy and safety of teriparatide and alendronate for the treatment of osteoporosis. Results Only 6 literatures were included in this meta-analysis (760 cases). The increases of lumber BMD in these studies were different. The meta-analysis was conducted by using the random and effect model. The results showed that the increase level of lumbar BMD during follow-up was 5. 16% (95%CI, 4.07% ~6.26% ) higher in teriparatide group than in alendronate group (P < 0. 01 ) , and the difference was statistically significant. The complications during the follow-up included hypercalcium (2. 84% in teriparatide group) and back pain (3.98% in alendronate group). The combined OR was 0. 75 (95% CI, 0. 51 ~ 1. 11 ) showing by the solid effect meta-analysis. There was no statistical difference ( P = 0. 15 ). Conclusion Meta-analysis shows that the efficacy of teriparatide is much higher than that of alendronate for the treatment of osteoporosis. And the safety of the two is similar. However,perspective clinical comparative studies of higher quality are still required for further analysis.%目的 评价特立帕肽与阿仑膦酸盐对比治疗骨质疏松症有效性和安全性的差异.方法 荟萃分析.采用Cochrane系统评价的方法,检索Medline(1966～2011年)、EMbase(1966～2010年)、Cochrane图书馆(2010年)及中国生物医学文献数据库CBM(1979 ～2010年)有关采用特立帕肽或阿仑膦酸盐治疗骨质疏松症的临床对照研究文献资料,按照纳入和排除标准限定研究对象,通过Jadad评分量表进行文献质量评估后,使用Cochrane协作网提供的RevMan 4.2统计软件进行Meta分析,以获得二者治疗骨质疏松症的疗效和安全性是否有差异的相关证据.结果 共纳入使用特立帕肽或阿仑膦酸盐治疗骨质疏松症的临床对照研究6项(760例).各项研究中腰椎BMD的升高幅度存在异质性,采用随机效应模型进行Meta分析,特立帕肽治疗组在随访期间腰椎BMD的升高幅度比阿仑膦酸盐组高5.16％(95％CI,4.07％ ～6.26％),P＜0.01,差异具有显著的统计学意义.随访期内发生的不良反应包括高钙血症(2.84％,特立帕肽组),背痛(3.98％,阿仑膦酸盐组)等.采用固定效应模型进行M ete分析,合并OR值为0.75( 95％ CI,0.51 ～1.11),P=0.15,两组间差异无统计学意义.结论 特立帕肽对骨质疏松症患者腰椎BMD的升高幅度高于阿仑膦酸盐,二者的安全性近似,但尚需更多高质量的前瞻性临床对照研究进一步证实.