中国药物警戒 ›› 2021, Vol. 18 ›› Issue (8): 784-788.
DOI: 10.19803/j.1672-8629.2021.08.19

• 安全与合理用药 • 上一篇    下一篇

山东省570家医疗机构5 066例药物性肝损伤不良反应报告分析

苏凤云1, 潘恩2, 卓龙冉1, 张许1, 李长秀1, 王丽1, 许莉莉3, 吴世福3,*   

  1. 1山东第一医科大学第二附属医院,山东 泰安 271000;
    2泰安市药品不良发应监测中心,山东 泰安 271000;
    3山东省药品不良反应监测中心,山东 济南 250014
  • 收稿日期:2020-03-05 出版日期:2021-08-15 发布日期:2021-08-17
  • 通讯作者: *吴世福,男,主任药师,药品不良反应监测与评价。E-mail：wushifu01@shandong.cn。
  • 作者简介:苏凤云,女,硕士,临床药学。
  • 基金资助:
    山东省药品不良反应监测中心项目（2017SDADRKY05）

Analysis of 5 066 Cases of Drug-induced Liver Injury from 570 Medical Institutions in Shandong

SU Fengyun1, PAN En2, ZHUO Longran1, ZHANG Xu1, LI Changxiu1, WANG Li1, XU Lili3, WU Shifu3,*   

  1. 1The Second Affiliated Hospital of Shandong First Medical University, Tai'an Shandong 271000, China;
    2Tai'an Center for ADR Monitoring, Tai'an Shandong 271000, China;
    3Shandong Center for ADR Monitoring, Jinan Shandong 250014, China
  • Received:2020-03-05 Online:2021-08-15 Published:2021-08-17

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摘要： 目的 了解山东省近5年药物性肝损伤（DILI）发生的情况和特点,为临床药物警戒和安全用药提供参考。方法 采用回顾性分析的方法,从山东省药品不良反应（ADR）监测中心数据库中提取并筛选出2013年1月1日至2018年7月31日上报的符合DILI判定标准的案例,对患者的性别、年龄、民族、既往史、药物类别/剂型、给药途径、潜伏期、原患疾病、疾病转归等进行统计分析。结果 从5 530例上报案例中筛选出符合DILI判定标准的共5 066例,来自570家医疗机构的门急诊和住院患者,其中男女比例约为1.42∶1;（40~59）岁年龄组发生率最高（1 991例,39.34%）;涉及17类789种药物,其中抗感染类药物（含抗结核药物）占比最大（2 537例,34.81%）;口服给药是最常见的给药途径（3 411例,67.33%）;原患疾病以结核病最多见（933例,18.42%）;DILI的潜伏期中位数为52.09（35.12,104.05）d,以7~14 d最多见（1 682例,33.23%）;主要肝脏生化指标中位数分别是丙氨酸氨基转移酶（ALT）130.00（90.00例,215.00）U/L、门冬氨酸氨基转移酶（AST）90.00（65.00,150.00）U/L、总胆红素（TB）52.09（35.13,104.05）μmol/L、直接胆红素（DB）36.07（16.70,80.00）μmol/L;大部分患者的转归为痊愈或好转（4 298例,84.84%）。结论 临床医务人员需提高对DILI的全面认识,加强对高危人群和高危药品的监测。

关键词: 药物性肝损伤, 临床特征, 回顾性分析

Abstract: Objective To investigate the incidence and characteristics of drug-induced liver injury (DILI) in Shandong province over the past five years, and provide reference for pharmacovigilance and clinical safety of medication. Methods From the database of Shandong ADR Monitoring Center, cases of DILI reported between January 1, 2013 and July 31, 2018 were retrieved and screened. Data on the gender, age, ethnicity, disease history, varieties of drugs, drug categories, routes of administration, latency, primary diseases and disease outcomes of patients was collected and analyzed. Results Among the 5 530 reported cases, 5 066 cases met DILI diagnostic criteria, who were outpatients, emergency patients or inpatients from 570 medical institutions. The ratio of males to females was about 1.42∶1, and the incidence was the highest (1 991 cases, 39.34%) among patients aged 40 to 59. There were 17 categories and 789 kinds of drugs involved, among which anti-infective drugs (including anti-tuberculosis drugs) accounted for the largest proportion (2 537 cases, 34.81%). Oral administration was the most common (3 411cases, 67.33%). Tuberculosis was the dominating primary disease (933 cases, 18.42%). The median latency was 52.09 (35.12, 104.05) d, while the most common latency was 7~14 d(1 682 cases, 33.23%). The median indexes of main liver function were ALT 130.00（90.00, 215.00）U/L, AST 90.00（65.00, 150.00）U/L,TB 52.09（35.13, 104.05）μmol/L, DB36.07(16.70, 80.00) μmol/L. Most patients recovered or improved after treatment (4 298 cases, 84.84%). Conclusion Clinical medical staff need to improve their comprehensive understanding of DILI and strengthen the monitoring of high-risk groups and high-risk drugs.

Key words: drug induced liver injury, clinical features, retrospective analysis

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