TOXRUN - Toxicology Research Unit, University Institute of Health Sciences, Advanced Polytechnic and University Cooperative (CESPU), CRL, Gandra, Portugal.
Department of Public Health and Forensic Sciences, and Medical Education, Faculty of Medicine, University of Porto, Porto, Portugal.
Basic Clin Pharmacol Toxicol. 2021 Sep;129(3):278-282. doi: 10.1111/bcpt.13631. Epub 2021 Jul 2.
The present case describes in detail a 55-year-old woman diagnosed with acute liver injury 3 days after completion of the first treatment course with ulipristal acetate (UPA), 5 mg/day orally for uterine fibroids causing persistent bleeding (treatment duration of 109 days). Liver transplantation was performed approximately 6 weeks after UPA suspension, and a photograph of the explanted liver is presented. Of note, other common causes of acute liver injury, such as history of alcohol or other psychoactive substances abuse, viral hepatitis and autoimmune hepatitis or preexisting liver disease were all excluded. This case was reported to the European Medicines Agency (EMA) and contributed to the final recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) disclosed in January 2021. The causality assessment considered a probable case of drug-induced liver injury as a consequence of UPA treatment, and the Roussel Uclaf Causality Assessment Method (RUCAM) was scored as unlikely. Although further studies are needed aiming to avoid confounding factors, this case suggests that liver function tests should be monitored during treatment with UPA.
本病例详细描述了一位 55 岁女性，因子宫纤维瘤导致持续出血，在完成醋酸乌利司他（UPA）首疗程治疗（5mg/天，口服，疗程 109 天）3 天后被诊断为急性肝损伤。在停用 UPA 约 6 周后进行了肝移植，并提供了移植肝脏的照片。值得注意的是，已排除其他常见的急性肝损伤原因，如酒精或其他精神活性物质滥用史、病毒性肝炎和自身免疫性肝炎或预先存在的肝脏疾病。该病例已向欧洲药品管理局（EMA）报告，并促成了 2021 年 1 月披露的药物警戒风险评估委员会（PRAC）的最终建议。因果关系评估认为 UPA 治疗后可能发生药物性肝损伤，Roussel Uclaf 因果关系评估方法（RUCAM）评分为不太可能。虽然需要进一步的研究以避免混杂因素，但该病例提示在使用 UPA 治疗期间应监测肝功能试验。
