73例抗肿瘤药物致肝损害不良反应/事件分析

中国药物警戒 ›› 2011, Vol. 8 ›› Issue (11): 690-693.

73例抗肿瘤药物致肝损害不良反应/事件分析

甘戈¹, 顾成杰²

1 江苏省药品不良反应监测中心,江苏南京 210002;
2 南京医科大学,江苏南京 210029

收稿日期:2011-03-21 出版日期:2011-11-10 发布日期:2015-07-30
作者简介:甘戈,男,副主治药师,药品不良反应监测。

Analysis of 73 Adverse Drug Reaction/Event Reports on Liver Damage Induced by Anticancer Drugs

GAN Ge¹, GU Cheng-jie²

1 Jiangsu Center for ADR Monitoring, Jiangsu Nanjing 210002, China;
2 Nanjing Medical University, Jiangsu Nanjing 210029, China

Received:2011-03-21 Online:2011-11-10 Published:2015-07-30

摘要/Abstract

摘要： 目的探讨抗肿瘤药物致肝损害的特点和规律。方法采用回顾性研究方法,对2004年至2010年6月江苏省药品不良反应监测中心收集的73例抗肿瘤药物致肝损害不良反应/事件报告进行综合分析。结果 73例药品不良反应报告表中涉及44种抗肿瘤药物,其中顺铂、吉西他滨、阿糖胞苷位居前三位;静脉用药不良反应发生比例最高,占86.3%;肝损害多在用药后1~2周内,临床表现为黄疸、乏力、发热、恶心、纳差、腹胀、腹痛、水肿、胸闷、皮疹、瘙痒、食欲减退;肝功能检查：丙氨酸氨基转移酶（ALT）在48~2 610U/L之间,总胆红素（TBil）在6.7~260.1μmol/L之间。结论应加强抗肿瘤药物致肝损害的研究及防治。

关键词: 抗肿瘤药物, 肝损害, 药品不良反应/事件, 吉西他滨

Abstract: Objective To investigate the epidemiological characteristics of liver damage induced by anticancer drugs. Methods With retrospective case study, analyzed 73 liver damage ADR/ADE reports induced by anticancer drugs in Jiangsu province from 2004 to June 2010. Results 73 ADR/ADE reports included 44 anticancer drugs, and the incidences of liver damage by Cisplatin、Gemcitabine and Vidarabine occupied the front 3 places in sequence. The drugs for intravenous administration resulted in the highest rate(86.3%), and most of the patients have ADR/ADE in 1~2 weeks. The clinical manifestations were jaundice, fatigue, fever, abdominal distension, abdominal pain, dark urine, nausea, edema, chest tightness, rash, itching, anorexia. Liver function examination showed that alanine amino transferase was in 48~2 610 U/L, and total bilirubin was in 6.7~260.1μmol/L in average. Conclusion It should be strengthening the observation and evaluation of liver damage induced by anticancer drugs.

Key words: anticancer drugs, liver damage, adverse drug reaction/event(ADR/ADE), gemcitabine

中图分类号:

R979.1

甘戈, 顾成杰. 73例抗肿瘤药物致肝损害不良反应/事件分析[J]. 中国药物警戒, 2011, 8(11): 690-693.

GAN Ge, GU Cheng-jie. Analysis of 73 Adverse Drug Reaction/Event Reports on Liver Damage Induced by Anticancer Drugs[J]. Chinese Journal of Pharmacovigilance, 2011, 8(11): 690-693.

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