A case of teriflunomide-induced hepatic injury: assessing causality using available rules

Kathy T. LeSaint, J. Waksman, C. Smollin
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引用次数: 5

Abstract

Abstract Teriflunomide, a pyrimidine synthesis inhibitor approved for treatment for the relapsing form of multiple sclerosis, has been deemed reasonably safe though hepatic toxicity is a rare serious adverse event. We report an uncommon case of a 48-year-old man who developed severe hepatotoxicity within a short time after initiation of teriflunomide treatment with resolution of signs and symptoms after drug discontinuation and concomitant treatment with cholestyramine. In this case, we provide a general framework regarding the assignment of causation in potential causes of drug-induced liver injury. The patient met the case definition of Hy’s law and his hepatotoxicity was assessed as causally related to teriflunomide using the Roussel Uclaf Causality Assessment Method (RUCAM).
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特立氟米特致肝损伤1例:利用现有规则评估因果关系
泰瑞氟米特(Teriflunomide)是一种嘧啶合成抑制剂,被批准用于治疗复发型多发性硬化症,尽管肝毒性是一种罕见的严重不良事件,但被认为是相当安全的。我们报告一个罕见的病例,一位48岁的男性在开始特立氟米特治疗后短时间内出现严重的肝毒性,停药后症状和体征得到缓解,并同时使用胆胺治疗。在这种情况下,我们提供了一个关于在药物性肝损伤的潜在原因的因果分配的一般框架。该患者符合Hy定律的病例定义,采用Roussel Uclaf因果关系评估法(RUCAM)评估其肝毒性与特氟米特有因果关系。
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