社團法人臺灣臨床藥學會

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【案例報告】疑似Terbinafine導致急性肝傷害:案例報告
Suspected Terbinafine Induced Acute Liver Injury: A Case Report
terbinafine、療黴舒、藥物肝傷害、急性肝傷害、肝炎、Terbinafine, Lamisil®, Drug-Induced Liver Injury, Acute Liver Injury, Hepatitis
邵時傑Shih-Chieh Shao1.2 、高淑敏Shu-Min Kao3 、高雅慧Yea-Huei Kao*1 、張定宗Ting-Tsung Chang4
1國立成功大學醫學院臨床藥學與藥物科技研究所 、2行政院衛生署基隆醫院藥劑科 、3國立成功大學醫學院附設醫院藥劑部 、4國立成功大學醫學院附設醫院內科部
Terbinafine為抗黴菌藥物,臨床上此藥導致的肝傷害屬罕見(約0.1%)之不良反應。目前認為的致病機轉可能包括:terbinafine或其代謝物直接對肝細胞產生毒性、terbinafine誘發之免疫反應及基因多型性等因素所造成。過去案例報告中,病人發病時,血液生化值會有各種不同型態的增加(alanine aminotransferase, ALT、alkaline phosphatase, ALP或兩者),大多在服藥後5 ~ 42天發病,並於停藥後平均165天,肝功能相關檢查結果才會恢復至服藥前。
本案例是一名61歲男性,於2011年5月20日因手指甲癬至診所就醫,並開始服用terbinafine 250 mg qd。病人於6月30日出現皮膚癢及手掌黃等症狀,7月10日ALT上升至977 U/L而住院。經過排除其他疾病與用藥史評估,懷疑是由terbinafine所造成肝臟之不良反應,Roussel Uclaf causality assessment method (RUCAM)評分為9分,因果關係屬極可能。
 
Terbinafine is an antifungal agent, and the incidence of hepatic side effects is rare (about 0.1%). The proposed mechanisms have involved the toxicity or metabolite of terbinafine, immune response and genetic polymorphism. In previous case reports, terbinafine caused remarkable increase of either or both of alanine aminotransferase (ALT) and alkaline phosphatase (ALP). Most patients have an onset duration between 5 to 42 days. Most of them need a period of time (mean: 165 days) to recover their liver function.
This report was to present a 61 year-old male patient who suffered from acute liver injury. He took 250 mg qd of terbinafine for his fingernail onychomycosis from May 20th of 2011. He developed itch and yellow palm on June 30th of 2011, and his ALT rapidly increased to 977 U/L on July 10th of 2011. After surveys, we highly suspected terbinafine was the cause for this adverse event Scores of Roussel Uclaf causality assessment method (RUCAM) was 9, suggesting a highly probable causality.
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