摘要
目的基于FDA不良事件报告系统(FAERS)数据库对质子泵抑制剂(PPIs)的不良事件信息进行分析对比,挖掘其潜在的不良反应信号,以期优化患者治疗方案,为临床安全合理用药提供参考依据。方法从FAERS提取2015年第1季度至2020年第4季度共24个季度的不良事件报告数据,利用比值比法(ROR)和综合标准法(MHRA法)对PPIs的报告进行数据挖掘。得到有效信号后,利用MedDRA术语集进行汉化及系统归类。结果经过二次筛选后结果显示:奥美拉唑累及23个器官系统分类(SOC),共540个信号;泮托拉唑共累及23个器官系统分类(SOC),共340个信号;艾司奥美拉唑累及22个器官系统分类(SOC),共239个信号;兰索拉唑累及22个器官系统分类(SOC),共298个信号。结论该研究获得的常见药物不良事件(ADE)信号及其累及系统与说明书一致,证明了该研究的可靠性。4种PPIs之间ADR具有一定的差异性,可为临床用药提供一定的参考,有利于促进临床合理用药。
Objective To analyze and compare the adverse event information of proton pump inhibitors(PPIs)based on the FAERS database,and to explore the potential adverse events signals in order to optimize the treatment plan for patients and provide a reference basis for clinical safe and rational drug use.Methods A total of 24 quarters of adverse events report data from the first quarter of 2015 to the fourth quarter of 2020 are extracted from FAERS.Data mining is performed on the PPIs report using the odds ratio(ROR)and medicines and healthcare products regulatory agency(MHRA)method.After obtaining the effective signals,the term set of MedDRA is used for translation and systematic classification.Results After the secondary screening,the results showed that omeprazole involved 23 organ system classifications(SOC)with a total of 540 signals.Pantoprazole involved 23 SOC with a total of 340 signals.Esomeprazole involved 22 ROC with a total of 239 signals.Lansoprazole involved 22 ROC with a total of 298 signals.Conclusion The common ADR signals and the involved systems obtained in this study are consistent with the instructions,which proves the reliability of this study.There are certain differences among the ADR of 4 PPIs,which can provide a reference for clinical drug use and promote rational drug use.
作者
白雪霏
冉怡雯
赵尹瑜
赵锦霞
陈力
BAI Xuefei;RAN Yiwen;ZHAO Yinyu;ZHAO Jinxia;CHEN Li(Department of Pharmacy,Evidence-Based Pharmacy Center,West China Second Hospital,Sichuan University,Chengdu 610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Ministry of Education,Chengdu 610041,China;West China School of Pharmacy,Sichuan University,Chengdu 610041,China)
出处
《医药导报》
CAS
北大核心
2021年第8期1131-1139,共9页
Herald of Medicine
基金
四川省科技厅项目(2019JDR0163)。
关键词
质子泵抑制剂
FDA不良事件报告系统
不良事件信号挖掘
比值比法
综合标准法
Proton pump inhibitors
FAERS
Adverse event signal mining
Reporting odds ratio method
medicines and healthcare products regulatory agency method
