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。
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.
作者
庞宁
郭代红
寇炜
贾王平
杨鸿溢
王啸宇
PANG Ning;GUO Daihong;KOU Wei;JIA Wangping;YANG Hongyi;WANG Xiaoyu(PLA Medical College, Beijing 100853, China;School of Life Science and Biopharmaceuticals, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China)
出处
《中国药物警戒》
2019年第4期219-222,共4页
Chinese Journal of Pharmacovigilance
基金
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
关键词
奥美拉唑
肝功能异常
肝损害
自动监测
omeprazole
abnormal liver function
hepatic impairment
automatic surveillance
