社團法人臺灣臨床藥學會

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【原著】藥物引起肝毒性之不良反應案例分析
The Analysis of Adverse Drug Reactions in Drug-Induced Liver Disease
藥物引起之肝毒性、不良反應、急性肝細胞傷害、Drug-induced liver disease, adverse reaction, acute hepatocellular injury
蔡慈貞Tzu-Cheng Tsai1 、曾瓊慧Chiung-Hui Tseng 、鄧新棠Shin-Tarng Deng*2
1林口長庚紀念醫院 臨床藥學科 、2林口長庚紀念醫院 藥劑部
        回溯分析本院民國 91 年至 94 年間,藥物引起肝臟毒性之不良反應通報總件數為 25 件,佔總通報案件的 2%。抗結核藥(36%)及抗癲癇藥(32%)所引起之肝毒性案例最多,acetaminophen 有 3 件(12%)。22 例(88%)造成急性肝細胞傷害(acutehepatocellular injury),釋出大量天門冬酸轉胺酶(aspartate aminotransferase; AST)及丙胺酸轉胺酶(alanine aminotransferase; ALT),其中 11 例(44%)伴隨膽紅素(bilirubin)上升;1 例(4%)為膽汁鬱滯性肝炎(cholestatic hepatitis);2 例(8%)為混合型肝傷害(mixed type injury)。
        多數案例於停藥後 23 天(範圍 5-90 天)其肝臟酵素及膽紅素皆逐漸回復至正常範圍,僅 3 例因 acetaminophen、isoniazid 及 phenobarbital 引起猛爆性肝炎(fulminanthepatitis)而致死。較嚴重的肝損害常合併高膽紅素,其恢復期較長,需約 34 天才能回復至正常。

        Twenty-five patients were found in our retrospective review of drug-induced liver disease (DILD) in our hospital from 2002 to 2005. We enrolled 25 patients to this study, about 2% of total adverse reaction reported. The most patients of DILD were associated with anti-tuberculosis (36%) and anti-epileptic drugs (32%) in our study. Three (12%) patients were associated with acetaminophen. Acute hepatocellular injury was found in 22 patients (88%), accompanied with marked elevation of aspartate aminotransferase and alanine aminotransferase, 11 patients (44%) with hyperbilirubinemia. The other three patients were associated with cholestatic hepatitis ( 4 %) or mixed type injury (8%) respectively.
        Most of DILD patients took about 23 days to recover (range: 5-90) after withdraw the precipitated drug. Only three fulminant hepatitis cases were induced by acetaminophen, isoniazid and phenobarbital and expired in our study. The recovery of hyperbilirubinemia patient took about 34 days that longer than without hyperbilirubinemia. In conclusion, patients with severe drug-induced liver injury take longer time to convalesce.
 
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