英国 MHRA 建议进一步限制 ulipristal 在子宫肌瘤中的应用
英国药品和医疗产品监管署（Medicines and Healthcare products Regulatory Agency, MHRA）建议，由于出现严重肝损伤病例，应进一步限制使用 ulipristal。[134]
ulipristal 于 2012 年首次获批，用于育龄女性子宫肌瘤中重度症状的间歇治疗或术前治疗。2018 年，在出现严重肝损伤（包括导致移植的肝衰竭）的报道后，欧洲药品管理局（European Medicines Agency, EMA）对 ulipristal 治疗子宫肌瘤的获益和风险进行了审查，已采取措施以将其风险最小化。[135] 然而，尽管遵循风险最小化措施，但此类病例之后又发生了一例重度肝损伤，导致进行肝移植，因此 EMA 在 2020 年初启动了新的安全性审查。MHRA 也发布了 ulipristal 药物安全性更新信息，提出了相似的建议。[137]
EMA 药物警戒风险评估委员会（Pharmacovigilance Risk Assessment Committee, PRAC）建议撤销该药物针对此适应证在欧洲的上市许可。[138] 但是，经过慎重考虑，他们已经证实，对于无其他治疗选择的患者，ulipristal 对控制子宫肌瘤的获益可能超过该风险。因此，他们现在建议仍然可使用 ulipristal 治疗无法接受手术（或手术无效）的绝经前患者。[133] 乌利司他勿用于待手术治疗患者控制子宫肌瘤。
MHRA 现已同意 ulipristal 的暂时停用应予以解除，但其应用应进一步限于停经前有中重度子宫肌瘤症状的女性，作为手术治疗（包括子宫肌瘤栓塞术）不适合或失败时的间歇治疗。[134]
小结
定义
病史和体格检查
诊断性检查
治疗流程
撰稿人
作者
Ayman Al-Hendy, MD PhD FRCSC FACOG CCRP
Professor (visiting) and Director
Translational Research
Department of Obstetrics and Gynecology
University of Illinois
Chicago
IL
利益声明
AAH serves on the external advisory board of Bayer, AbbVie, Myovant, and Allergan, and has received research funding from the National Institutes of Health. AAH is an author of references cited in this topic.
Obianuju Sandra Madueke-Laveaux, MD MPH
Assistant Professor of Obstetrics and Gynecology
Department of Obstetrics and Gynecology
University of Illinois
Chicago
IL
利益声明
OSML declares that she has no competing interests. OSML is an author of references cited in this topic.
Vuslat Lale Bakir, MD
Assistant Professor of Obstetrics and Gynecology
Department of Obstetrics and Gynecology
Haseki Training and Research Hospital
Health Sciences University
Istanbul
Turkey
利益声明
VLB declares that she has no competing interests.
鸣谢
Dr Al-Hendy, Dr Madueke-Laveaux, and Dr Bakir would like to gratefully acknowledge Dr Mohamed Mitwally, Dr Intisar Elnahhas, and Dr Robert J. Fischer, the previous contributors to this topic.
利益声明
MM, IE, and RJF declare that they have no competing interests.
同行评议者
Everett Magann, MD
Chairman
Department of Obstetrics and Gynecology
Naval Medical Center
Portsmouth
VA
利益声明
EM declares that he has no competing interests.
Amy Niederhauser, MD
Doctor
Department of Obstetrics and Gynecology
Naval Medical Center
Portsmouth
VA
利益声明
AN declares that she has no competing interests.
Adam Magos, BSc, MB, BS, MD, FRCOG
Consultant Gynaecologist
University Department of Obstetrics and Gynaecology
Royal Free Hospital
London
UK
利益声明
AM declares that he has no competing interests.
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