骨质疏松症治疗药物——艾尔骨化醇  

Eldecalcitol used for treating osteoporosis

作　　者：曾婧娉[1,2] 阎卉[2] 王成港[2] 王春龙[2] 

机构地区：[1]天津医科大学,天津300070 [2]天津药物研究院释药技术与药代动力学国家重点实验室,天津300193

出　　处：《药物评价研究》2011年第3期224-229,共6页Drug Evaluation Research

摘　　要：日本厚生省于2011年1月21日批准骨质疏松症治疗药物——艾尔骨化醇上市,其有效物质艾尔骨化醇是继阿法骨化醇后又一新的用于治疗骨质疏松症的活性维生素D3衍生物。一项由1054例骨质疏松症患者参加的历时3年的III期临床数据显示,艾尔骨化醇疗效优于阿法骨化醇,且安全性与阿法骨化醇相似,具有较好的应用前景。After following alfacalcidol, eldecalcitol （brand name Edirol）, obtained an approval to market in 21th January, 2011 from the Japanese Ministry of Health, Labour and Welfare （MHLW） for the treatment of patient with osteoporosis, is a novel active vitamin D3 derivative. During three years of the phase III study on 1054 patients suffered from osteoporosis, the three-year incidence of bone fractures were observed and the safety of eldecalcitol used for the treatment of those patients with osteoporosis was compared to that of alfacalcidol. The patients who received eldecalcitol had a significantly lower three-year incidence of new vertebral fractures. Overall, the safety profiles of the two agents are similar, which indicates that eldecalcitol is superior to alfacalcidol and has a better prospect in preventing and treating fractures.

关 键 词：活性维生素D3 艾尔骨化醇(eldecalcitol)Edirol 阿法骨化醇 骨质疏松 

分 类 号：R681[医药卫生—骨科学]