特立帕肽与降钙素治疗绝经后骨质疏松症疗效与安全性的Meta分析

Meta Analysis on Efficacy and Safety of Teriparatide and Calcitonin in the Treatment of Postmenopausal Osteoporosis

目的：系统评价特立帕肽与降钙素在治疗绝经后骨质疏松症的疗效与安全性的差异。方法：以＂特立帕肽＂、＂重组人甲状旁腺素（1-34）＂与＂降钙素＂、＂绝经后骨质疏松症＂等为关键词,检索国内2002年1月至2015年9月期间发表的相关文献;以修订后Jadad评分量表评价纳入的研究质量,使用Review manager 5.3软件进行Meta分析。结果：通过关键词检索,共检出25篇文献,按照既定的纳入和排除标准筛选,共7篇文献进入本研究（767例）。各项研究中的腰椎（2~4）骨密度（BMD）的升高数值不存在异质性,采取固定效应模型进行Meta分析,特立帕肽组在随访期间腰椎骨密度升高数值比降钙素组高0.02个单位（95%CI：0.00,0.03）,P〈0.05,差异具有统计学意义。7篇文献均对随访期间发生的不良反应进行了报道,包括头晕、恶心、乏力、一过性皮疹和关节疼痛等,平均发生率25.03%（特立帕肽组26.63%,降钙素组23.14%）。采用固定效应模型对两组不良反应发生例数进行Meta分析,合并OR值为1.29（95%CI：0.92,1.82）,P〉0.05,两组间差异无统计学意义。结论：本研究显示特立帕肽在治疗女性绝经后骨质疏松症的过程中,对腰椎骨密度的提升幅度高于降钙素,二者在安全性方面差异不大,特立帕肽在绝经后骨质疏松症的临床治疗方面值得重视与推广。但结论尚需更多高质量的临床随机对照研究进一步证实。

Objective： To evaluate the difference of teriparatide and calcitonin in the treatment of postmenopausal osteoporosis clinical efficacy and safety. Methods： Keywords in the＂teriparatide＂,＂recombinant human parathyroid hormone 1-34（rhPTH1-34） ＂ and ＂calcitonin＂,＂postmenopausal osteoporosis＂,search for the relevant literature published between September 2015 and January 2002; Study on the quality of the included in the revised Jadad scale,Meta analysis using manager Review 5. 3 software. Results： Through keyword search,a total of 25 articles are detected,According to the established inclusion and exclusion criteria,a total of 7 literatures are included in this study. In the study,the L_（2-4） BMD values are not heterogeneous,Meta analysis is carried out using fixed effect model,Teriparatide group increase 0. 02 units of lumbar bone mineral density value than calcitonin group during the follow-up period（ 95% CI： 0. 00,0. 03）,P 0. 05,the difference was statistically significant. The adverse reactions occurred during the follow-up were reported in the 7papers,including dizziness,nausea,fatigue,a rash and joint pain,etc,the average rate is 25. 03%（ Teriparatide group 26. 63%,calcitonin group 23. 14%）. Meta analysis is carried out using fixed effect model,the combined OR value is 1. 29（ 95% CI： 0. 92,1. 82）,P 0. 05,there is no significant difference between the two groups. Conclusion： This study showed that the teriparatide increase higher units in lumbar spine bone mineral density during the treatment of female postmenopausal osteoporosis than that of calcitonin,the two groups in the security of the difference is not big. But the conclusion still needs more high quality clinical randomized controlled study to further confirm.