国际妇产科学杂志 ›› 2018, Vol. 45 ›› Issue (4): 427-430.

• 综述 • 上一篇    下一篇

一种新型口服GnRH拮抗剂——Elagolix

王诗惠,张杰,纪英博,张永凯   

  1. 130000  长春,吉林大学第一医院药学部
  • 收稿日期:2018-05-21 修回日期:2018-06-18 出版日期:2018-08-15 发布日期:2018-08-15

A New Oral GnRH Antagonist—Elagolix

WANG Shi-hui,ZHANG Jie,JI Ying-bo,ZHANG Yong-kai   

  1. Department of Pharmacy,The First Hospital of Jilin University,Changchun 130000,China
  • Received:2018-05-21 Revised:2018-06-18 Published:2018-08-15 Online:2018-08-15

摘要: 艾伯维(AbbVie)于2017年9月6日向美国食品药品监督管理局(FDA)提交了将Elagolix用于治疗子宫内膜异位症的新药申请,并在1个多月后获得了FDA的优先审评资格。Elagolix是一种口服的促性腺激素释放激素拮抗剂(GnRHA),对于子宫内膜异位症引起的月经痛和非月经盆腔痛具有很好的疗效。与以往大家所熟知的GnRH激动剂(GnRHa)相比,具有较高的口服生物利用度,避免了注射引起的疼痛感和过敏反应,增加了患者依从性。目前该药物延期通过,涉及补充肝损伤的资料,FDA将于2018年第3季度回复意见,对于不良反应肝损伤的原理尚不清楚。Elagolix有望成为治疗子宫内膜异位症的新型口服GnRHA,对于后续研究进展将持续关注。

关键词: Elagolix, 子宫内膜异位症, 促性腺素释放激素

Abstract: AbbVie submitted a new drug application for Elagolix to the FDA on September 6, 2017, and received the FDA's priority review in more than a month. Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist, has the very good curative effect on endometriosis for menstrual pelvic pain. Compared with and previously known as GnRH agonists, Elagolix has high oral bioavailability, and avoid the pain caused by injection and allergic reaction, and increased patient compliance. Currently, the drug has been delayed to the FDA in the third quarter of 2018 regarding the supplementary data on liver injury. The principle of adverse reactions to liver injury is not clear. Elagolix hopes to be a new oral GnRH antagonist agent in the treatment of endometriosis, and we will continue to pay attention to the follow-up research progress.

Key words: Elagolix, Endometriosis, Gonadotropin-releasing hormone