Speciality Trainee in Obstetrics and Gynaecology, University Hospitals of Leicester NHS Trust, Leicester, LE1 5WW, UK.
Reproductive Medicine Unit, University College London Hospital, 235 Euston Road, London, NW1 2BU, UK.
Adv Ther. 2021 Jan;38(1):137-148. doi: 10.1007/s12325-020-01555-z. Epub 2020 Nov 17.
Ulipristal acetate (UPA) was introduced as a novel progesterone receptor modulator as effective therapy for symptomatic fibroids. Randomised clinical trials established its effectiveness in the management of heavy menstrual bleeding due to uterine leiomyomas. The trials did not find any significant evidence of clinical harm to the participants. Recently, however, there have been reports of liver injury necessitating liver transplant in women who have had UPA treatment. This has led to the suspension of UPA as one of the medical therapies in the treatment for uterine fibroids while the European Medicines Agency (EMA) conducts a review of liver injury risk with its use. The European Medicine Agency safety committee has advised that women should stop taking 5 mg UPA and that no new patients should commence treatment with the medicine until the ongoing review is completed. In this article, we review the rise of UPA as one of the emerging medical therapies for symptomatic uterine fibroids and the subsequent reports of adverse events leading to the suspension of its use.
醋酸乌利司他（UPA）作为一种新型孕激素受体调节剂，被引入作为治疗有症状子宫肌瘤的有效药物。随机临床试验确立了其在治疗因子宫肌瘤导致的月经过多方面的有效性。这些试验没有发现任何对参与者有临床危害的明显证据。然而，最近有报道称，在接受 UPA 治疗的女性中出现了需要进行肝移植的肝损伤。这导致 UPA 在治疗子宫肌瘤的药物治疗中被暂停，而欧洲药品管理局（EMA）正在对其使用的肝损伤风险进行审查。欧洲药品管理局安全委员会建议，妇女应停止服用 5 毫克 UPA，在正在进行的审查完成之前，不应有新的患者开始使用该药物。在本文中，我们回顾了 UPA 作为治疗有症状子宫肌瘤的新兴药物治疗方法之一的兴起，以及随后因不良事件报告而导致其使用被暂停的情况。
