军队医院1298例质子泵抑制剂类药物药品不良反应分析

Analysis of 1298 cases of adverse drug reactions induced by proton pump inhibitors in military hospitals

目的:了解质子泵抑制剂(PPIs)类药物所致药品不良反应(ADRs)的发生特点及规律,为临床合理用药提供参考。方法:采用回顾性分析方法,收集2009-01-01至2017-03-31军队ADRs监测管理系统中PPIs类药物ADRs报告1298例,对病人性别、年龄、引起ADRs药品种类、给药途径、剂型、累及系统/器官及临床表现、关联性评价及转归等情况进行分析。结果:1298例PPIs类药物所致ADRs中,新的和严重的ADRs 84例(6.47%),男女病人比例为1.29∶1,年龄为(51.58±17.70)岁,给药途径和剂型以静脉滴注和注射用粉针剂为主。1298例ADRs报告共涉及5个药物品种,居前三位的分别为:奥美拉唑(415例,31.97%)、兰索拉唑(382例,29.43%)和泮托拉唑(297例,22.88%)。ADRs累及多个系统/器官,共计1510例次,最常见的为皮肤及其附件损害(400例次,占26.49%),其次为消化系统损害(248例次,占16.42%)和全身性反应(244例次,占16.16%)。结论:应加强PPIs类药物的风险防范工作,合理使用PPIs类药物,重视ADRs的监测及药物咨询等工作,以减少或避免ADRs的发生。

Objective：To investigate the characteristics and regular patterns of adverse drug reactions（ADRs）induced by proton pump inhibitors（PPIs）,and provide references for clinical rational drug use.Methods：Totally,1298 ADRs induced by PPIs were collected from military ADRs monitoring and management system from January 1,2009 to March 31,2017 by retrospective analysis.The data of gender and age of patients,drug categories,administration routes,dosage forms,systems and organs affected by ADRs and clinical manifestations,relevance evaluation and prognosis were analyzed.Results：In the 1298 ADRs induced by PPIs,there were 84 new and severe cases of ADRs,accounting for 6.47%,with the male to female ratio of1.29∶1 and age range of（51.58± 17.70）.Medication routes and dosage forms were mainly intravenous infusion and powder injection.The ADRs were related with 5 kinds of drug categories,with the top 3 drug categories being omeprazole（415 cases,31.97%）,lansoprazole（382 cases,29.43%）and pantoprazole（297 cases,22.88%）.The ADRs affected multi systems and organs,with a total of 1510 cases-times.The most commonly affected sites were skin and its accessories（400 cases-times,accounting for 26.49%）,followed by digestive system damage（248 cases-times,accounting for 16.42%）and systemic damage（244 cases-times,accounting for 16.16%）.Conclusion：The risk prevention of PPIs should be strengthed.The use of PPIs should be more rational,and attention should be paid to the ADRs monitoring and drug consultation,so as to reduce or avoid occurrence of ADRs.