甲状旁腺素与二磷酸盐治疗绝经妇女骨质疏松症有效性及安全性评价——Meta分析

Validity and safety evaluation of parathyroid hormone and bisphosphonate in the treatment of osteoporosis in postmenopausal women: a Meta-analysis

目的评价甲状旁腺素与二磷酸盐治疗绝经妇女骨质疏松症有效性及安全性差异。方法通过检索Pubmed、Cochrane图书馆、EMbase、Highwire、中国生物医学文献数据库CBM、CNKI等中外生物医学数据库,收集有关应用甲状旁腺素与二磷酸盐治疗绝经妇女骨质疏松症的临床随机对照试验,检索文献日期从2002年1月至2012年9月。采用Cochrane系统评价方法,按照纳入和排除标准限定研究对象,评估所纳入研究的文献质量,并提取有效数据后采用RevMan5.0软件进行Meta分析。结果共纳入应用甲状旁腺素与二磷酸盐对比治疗绝经妇女骨质疏松症的临床对照研究9项(共1287例)。结果显示:在有效性方面,甲状旁腺素组比二磷酸盐组能提高绝经妇女骨质疏松症者腰椎BMD[WMD=3.96,95%CI(3.10,4.82)]和股骨颈BMD[WMD=2.05,95%CI(0.27,3.83)],而后者比前者更能提高髋BMD[WMD=-1.07,95%CI(-1.72,-0.41)];在安全性方面,甲状旁腺素组不良事件总发生率低于二磷酸盐组[WMD=0.87,95%CI(0.59,1.30)]。二者背痛与非椎体骨折发生率无显著差异,但前者血钙、尿钙超出正常水平发生率显著高于后者{血钙:[WMD=13.68,95%CI(6.12,30.59)];尿钙:[WMD=2.21,95%CI(1.14,4.26)]}。结论甲状旁腺素类药物比二磷酸盐类药物更能提高绝经妇女骨质疏松症病人腰椎、股骨颈BMD,改善骨质量的疗效肯定,且安全性较高。但在临床使用中,要定时监测患者血钙、尿钙水平,进一步提高用药安全性。

Objective To evaluate the differences of validity and safety between parathyroid hormone （PTH） and bisphosphonate in the treatment of osteoporosis in postmenopausal women. Methods Randomized clinical trials, which were about the treatment of osteoporosis in postmenopausal women using PTH and bisphosphonate, were searched in PubMed, Cochrane, Embase, High Wire, CBM, CNKI, and other national and international biomedical databases. The date of literatures retrieved was from January 2002 to September 2012. The evaluation method of Cochrane system was adopted. Research objects were def/ned according to inclusion and exclusion standard. The quality of literatures included in the research was evaluated, Valid data were extracted and analyzed using a RevMan 5.0 software for Meta-analysis. Results A total of 9 clinical control studies （including 1287 patients） of osteoporosis treatment in postmenopausal women using PTH and bisphosphonate were enrolled. In respect of validity, PTH could improve BMD of the lumbar vertebrae [lumbar： WMD =3.96, 95% CI （3.10, 4.82）1 and the femur neck [WMD =2.05, 95 % CI （0. 27, 3.83 ） I better than bisphosphonate in postmenopausal osteoporosis patients. The latter could improve hip BMD better than the former [WMD = - 1.07, 95% CI （ -1.72, -0.41）]. In respect ofsafety, total adverse events in PTH group were less than that in bisphosphonate group [ WMD = 1.81, 95% CI （1. 16, 2.80）]. The incidence of backache and non-vertebral fractures showed no obvious difference. Hypercalcemia [WMD = 13.68, 95% CI （6. 12, 30.59） ] and hypercalciuria [WMD = 2.21, 95% CI （1.14, 4.26） ] in PTH group occurred more often than that in bisphosphonate group. Conclusion PTH can improve BMD of the lumbar vertebrae and the femur neck in postmenopausal osteoporosis patients better than bisphosphonates. It can also improve bone quality and have higher safety. But in clinical use, we should monitor both blood and urine calcium levels in patients timely, in order to improve the safety of the drug use.