中国药物警戒 ›› 2019, Vol. 16 ›› Issue (4): 219-222.

• 安全性评价与合理用药 • 上一篇    下一篇

奥美拉唑相关肝功能异常与肝损害的自动监测对比研究

庞宁1,2, 郭代红1,*, 寇炜1, 贾王平1, 杨鸿溢1, 王啸宇1   

  1. 1解放军医学院,北京 100853;
    2沈阳药科大学生命科学与生物制药学院,辽宁 沈阳 110016
  • 收稿日期:2019-05-09 修回日期:2019-05-09 出版日期:2019-04-20 发布日期:2019-05-09
  • 通讯作者: 郭代红,女,主任药师·硕导,床药学与药物警戒。E-mail: guodh301@163.com
  • 作者简介:庞宁,女,在读硕士,临床药学。
  • 基金资助:
    2017年军事医学创新专项（17CXZ010）: 基于大数据的军队药物警戒体系建设研究; 中国研究型医院学会专项（HXKTGUODAIHONG001）: 罗沙替丁的安全性再评价研究

Automatic Surveillance and Comparative Study of Omeprazole Related Abnormal Liver Function and Hepatic Impairment

PANG Ning1,2, GUO Daihong1,*, KOU Wei1, JIA Wangping1, YANG Hongyi1, WANG Xiaoyu1   

  1. 1PLA Medical College, Beijing 100853, China;
    2School of Life Science and Biopharmaceuticals, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2019-05-09 Revised:2019-05-09 Online:2019-04-20 Published:2019-05-09

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摘要： 目的 通过“医疗机构ADE主动监测与智能评估警示系统”（active surveillance and assessment system of adverse drug events, ADE-ASAS）报警条件设置,获取奥美拉唑相关肝功能异常及肝损害自动监测结果。方法 分别以肝功能异常及肝损害判定标准对ADE-ASAS进行条件设置,对奥美拉唑肝功能异常及肝损害进行回顾性分析,并采用巢式病例对照研究方法分析相关因素。结果 在纳入的5 352例患者中,两种设置条件下,ADE-ASAS报警病例分别为1 256例、385例,发生肝功能异常175例（3.27%）,谷丙转氨酶（ALT）、谷草转氨酶（AST）、碱性磷酸酶（ALP）、总胆红素（TB）升高分别为126例（2.35%）、92例（1.72%）、25例（0.47%）、45例（0.84%）;肝损害64例（1.20%）涵盖了所有严重肝功能异常病例;合并使用抗菌药物为奥美拉唑致肝功能异常及肝损害的相关风险因素。结论 肝损害较肝功能异常严重,更应引起临床重视;以肝损害判定标准开展自动监测可显著降低人工甄别成本;奥美拉唑联用抗菌药物时更应警惕肝功能异常向肝损害发展的趋势。

关键词: 奥美拉唑, 肝功能异常, 肝损害, 自动监测

Abstract: Objective To set the alarm conditions of the active surveillance and assessment system of adverse drug events(ADE-ASAS), so as to obtain the automatic surveillance results of omeprazole related abnormal liver function and hepatic impairment. Methods The ADE-ASAS was set with the criteria for abnormal liver function and hepatic impairment. The abnormal liver function and hepatic impairment of omeprazole were analyzed retrospectively, and the correlative factors were analyzed by nested case control study. Results Of the 5 352 patients included, under the two setting conditions, there were 1 256 cases and 385 cases of alarm cases. There were 175 (3.27%) cases of abnormal liver function, including ALT cases (126,2.35%), AST cases (92, 1.72%), ALP cases (25, 0.47%) and TB cases (45, 0.84%), and 64(1.20%) cases of hepatic impairment. Combined use of antimicrobials was a risk factor for abnormal liver function and hepatic impairment caused by omeprazole. Conclusion Hepatic impairment is more serious than abnormal liver function and should be paid more clinical attention, and setting the system with the standard of hepatic impairment can significantly reduce the cost of human screening. The tendency of abnormal liver function to hepatic impairment should be warned when combined with antibacterial agents.

Key words: omeprazole, abnormal liver function, hepatic impairment, automatic surveillance

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