中国药物警戒 ›› 2017, Vol. 14 ›› Issue (8): 481-485.

• 安全性评价与合理用药 • 上一篇    下一篇

79家医院1110例药物性肝损害不良反应/事件分析

贾王平1, 郭代红1*, 田小燕2, 寇炜1, 王啸宇1, , 赵粟裕1, 胡鹏洲2   

  1. 1.解放军总医院药学部临床药学中心，北京 100853；
    2. 重庆医科大学药学院，重庆 401331
  • 收稿日期:2017-04-24 修回日期:2017-09-26 出版日期:2017-08-20 发布日期:2017-09-26
  • 通讯作者: 郭代红，女，主任药师，硕士生导师，临床药学与药物警戒。E-mail: guodh301@163.com
  • 作者简介:贾王平，男，药师，在读硕士，临床药学。
  • 基金资助:
    2014年全军后勤科研重点项目（BWS14R039）：军队药品风险监测防控技术与支撑平台的研究。

Analysis of 1110 Cases of Drug-induced Liver Injury in 79 Hospitals

JIA Wang-ping1, GUO Dai-hong1*, TIAN Xiao-yan2, KOU Wei1, WANG Xiao-yu1, ZHAO Su-yu1, HU Peng-zhou2   

  1. 1.Department of Pharmaceutical Care, PLA General Hospital, Beijing 100853, China;
    2. Chongqing MedicalUniversity, Chongqing, 401331, China
  • Received:2017-04-24 Revised:2017-09-26 Online:2017-08-20 Published:2017-09-26

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摘要： 目的 了解各类药物导致药物性肝损害（DILI）发生的情况和特点，为防治DILI提供参考。方法 采用回顾性分析的方法，从解放军药品不良反应监测中心数据库中提取并筛选2008～2016年严重不良反应报告中发生DILI的病例，对患者的性别及年龄、引起DILI的药品、实验室指标与主要临床表现、发生DILI的时间及给药途径、DILI转归及治疗等进行统计分析。结果 在1 110例DILI中，男女比例为1.51:1；男女患者年龄构成比差异具有统计学意义（χ2=11.330，P =0.01）；引起DILI前3大类药物依次为抗感染药物、神经系统用药、心血管系统用药；引起DILI频次较高的药物为阿托伐他汀、利福平、莫西沙星、左氧氟沙星等；在DILI的转归中，应用保肝药物的患者治愈和好转的构成比更高（χ2=25.136，P＜0.001）。结论 临床医务人员应加深对导致DILI药物的认识，合理用药；而对于DILI的患者，应及时停药，并积极对症治疗。

关键词: 药物性肝损害, 药品不良反应, 合理用药

Abstract: Objective To investigate the condition and characteristics of drug-induced liver injury(DILI), and provide reliable basis for theprevention and treatment of DILI. Methods The cases of DLLI were collected from database of PLA ADR Monitoring Center from 2008 to 2016 and then patients' information, suspicious drugs, laboratory indexes and major manifestations, occurring time of DILI and administration route, treatment and outcomes were analyzed retrospectively. Results Among 1 110 DILI cases, the ratio of males and females was 1.51:1. Significant differences of age existed between males and females (χ2=25.136, P=0.01). The three predominant drug classifications were anti-infective agents, nervous system drugs, cardiovascular system drugs orderly. The predominant drugs were atorvastatin, rifampicin, moxifloxacin and levofloxacin orderly. Significant difference of outcomes existed between patients taking liver-protecting drugs and patients not taking liver-protecting drugs (χ2=25.136,P＜0.001).Conclusion Clinical medical staffs should learn more about drugs and use them reasonably, drug withdrawal and other symptomatic treatments should be given in time for patients with DILI.

Key words: drug-induced liver injury(DILI), adverse drug reaction(ADR), appropriate medication

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