中国药物警戒 ›› 2013, Vol. 10 ›› Issue (7): 415-418.

• 药械安全性研究 • 上一篇    下一篇

162例药物性肝损害不良反应/事件报告分析

朱磊12,黄萍2,李颖3*   

  1. 1.安徽中医药大学,安徽合肥230031；
    2.安徽省药品不良反应监测中心,安徽合肥230051；
    3.安徽中医药大学第一附属医院,安徽合肥230031
  • 收稿日期:2013-04-26 修回日期:2016-03-09 出版日期:2013-07-08 发布日期:2016-03-09
  • 通讯作者: 李颖,女,副主任药师,硕士生导师,药品不良反应监测与评价。E-mail：ymh2003@126.com
  • 作者简介:朱磊,男,在读硕士,药品不良反应监测与评价。

Analysis of 162 Cases of Drug-induced Liver Injury

ZHU Lei1,2 ,HUANG Ping2 ,LI Ying3   

  1. 1.Anhui University of Chinese Medicine, Anhui Hefei 230031, China;
    2.Center for ADR Monitoring of Anhui, Anhui Hefei 230051, China;
    3.First Affiliated Hospital of Anhui University of Chinese Medicine, Anhui Hefei 230031, China
  • Received:2013-04-26 Revised:2016-03-09 Online:2013-07-08 Published:2016-03-09

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摘要： 目的 探讨药物性肝损害不良反应/ 事件发生的临床特点和规律,为临床合理用药提供参考。方法 采用回顾性研究的方法,从安徽省2012 年药品不良反应/ 事件数据库中筛选出162 例药物性肝损害病例,并行整理、统计与分析。结果统计数据显示药物性肝损害中,年龄≥60 岁的老年患者发生率最高,占35.80%。涉及10 大类药物,西药引起例次较多,占89.20%,其中以抗肿瘤药所占比重最大,其次为抗菌药、质子泵抑制剂和抗脑血管病药；中成药以中药注射剂引起例次最多,占8.92%。发生药物性肝损害的最常见给药途径是静脉滴注,占71.83%。肝损害发生时间差异较大,最短的1 天,最长的175 天。临床表现与实验室检查无明显特异性,大部分病例在停药和对症治疗后好转。结论临床医务人员应该提高对药物性肝损害的认识,一旦确诊为药物性肝损害,积极采取对症治疗,同时要加强不良反应监测,提高合理用药水平。

关键词: 药品不良反应, 药物性肝损害, 分析

Abstract: Objective To investigate the clinical characteristics and laws of drug-induced liver injury so as to promote the rational use of drugs. Methods Selecting 162 cases of ADRs which induced liver injury from Anhui's 2012 ADR database, and using the retrospective study Methods to analyze these cases of ADR. Results Drug-induced liver injury incidence is the highest in elderly patients whose age are over 60 years, accounting for 35.80%. Drug-induced liver injury report involveda total of 10 categories of drugs, in which caused by western medicine cases accounting for 89.20% and oncologic drugs is the largest share, followed by antibacterial drugs, proton pump inhibitors and anti-cerebral vascular drugs. Traditional Chinese medicine injections is the most proprietary in all of the Chinese medicines, accounting for 8.92% . The most common route of administration is intravenous infusion, accounting for 71.83%. Liver damage occurred in quite different time, the fastest is 1 day and the longest is 175 days, but clinical manifestations and laboratory tests were not significantly different. Most patients recovered after discontinuation and symptomatic treatment. Conclusion Doctors should improve the understanding of drug -induced liver injury which induced by ADR and must take symptomatic treatment actively as soon as the drug -induced liver injury is diagnosed. Additionally, doctors should strengthen the monitoring of ADR and improve the level of rational use of drugs.

Key words: adverse drug reactions, drug-induced liver injury, analysis

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