國內藥物不良反應通報資料分析藥品引起肝傷害

Drug-induced Liver Injury Based on Taiwan National Adverse Drug Reaction Reporting System

趙必暉(Pi-Hui Chao) ； 陳文雯(Wen-Wen Chen) ； 翁菀菲(Angela On)

《台灣醫學》 17卷5期 (2013/09) Pp. 457-467

https://doi.org/10.6320/FJM.2013.17(5).01

摘要

藥品引起肝傷害為國內不良反應通報資料庫中常見被通報的不良反應之一；近年來，亦為排名第三的藥害救濟申請案件原因。本研究目的為分析最新全國不良反應資料庫中因藥品引起肝傷害之通報資料，提供臨床醫療人員參考，並注意相關風險。本研究共統計2,476例肝傷害通報案例，約佔所有通報案例的3.8％；平均年齡為57.4 ± 20.7歲（mean ± SD），男女比例約為3：2。抗分枝桿菌類藥品約佔所有通報藥品種類的40％，排名第一；其次為phenytoin及oxacillin。比較近四年之資料結果亦雷同，唯rosuvastatin、trastuzumab、lapatinib、paclitaxel等藥品通報量上升，進入前十藥品名單。而相較於歐美國家，acetaminophen近年於國內被通報的案例數甚少。雖然多數藥品引起的肝傷害屬特異性，較難預防其發生，但適時的監測病患肝功能變化並給予適當的處置，可以減低不良反應的嚴重度及傷害性。本研究藉由分析全國藥物不良反應通報中心的資料，提供國內最新的通報情形，以期能強化藥物使用的合理性及安全性。

關鍵字

藥物 ； 不良反應 ； 肝傷害 ； 通報

並列摘要

Drug-induced liver injury (DILI) is one of the most reported adverse drug reactions (ADRs) in our database and it is also the third most frequently reported disorder in all applicants for drug hazard relief over these years. The objective of this study was to analyze the latest DILI-associated reports and to provide related information to health professionals. A total of 2,476 reports with liver injury which accounts for 3.8% of all reports were defined in the database. The average age was 57.4 ± 20.7 year-old and the ratio of female to male was two-third. Around 40% of reports with liver injury were related to anti-tuberculosis drugs, following by phenytoin (6%) and oxacillin (3%). Similar data were found in recent four years except the following four drugs entering the top 10 ranking: rosuvastatin, trastuzumab, lapatinib and paclitaxel. Comparing with western countries, fewer acetaminophen-associated liver injury cases were reported in Taiwan. Most drug-induced liver injuries are idiosyncratic and hard to prevent, but it could be mitigated by proper monitoring and management. With this report, we wish to enhance the rationality and safety of drug use in clinical practice.

並列關鍵字

DILI ； hepatotoxicity ； ADR ； reporting system