基于FDA不良事件报告系统数据库的奥美拉唑联用伏立康唑不良反应信号比值失衡分析  

Disproportional analysis of adverse reaction signal associated with the combination of omeprazole and voriconazole based on the FAERS database

作　　者：田丽凤 王莉 邱雄泉 秦方序 TIAN Lifeng;WANG Li;QIU Xiongquan;QIN Fangxu(Department of Pharmacy,Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Traditional Chinese Medicine,Guangdong Zhongshan 528400,China;Department of Pharmacy,Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University,Beijing 100010,China)

机构地区：[1]广州中医药大学附属中山中医院药学部,广东中山528400 [2]首都医科大学附属北京中医医院药学部,北京100010

出　　处：《临床药物治疗杂志》2025年第1期82-86,共5页Clinical Medication Journal

基　　金：广东省中山市科学技术局中山市社会公益与基础研究项目(2020B1105);广东省颐养健康慈善基金(JZ2023006);中山市医学科研项目(2022J007)。

摘　　要：目的 基于FDA不良事件报告系统(FAERS)数据库筛选奥美拉唑与伏立康唑联用时的不良反应信号,为临床合理使用提供参考。方法 检索2004—2023年FAERS数据库中奥美拉唑与伏立康唑不良事件报告,利用比例失衡法中的报告比值比法(ROR)和比例报告比值比法(PRR),比较奥美拉唑联用伏立康唑与各自单独使用时的潜在不良反应信号;同时对比这两种药物联用时的不良反应信号及累及系统器官。结果 共纳入奥美拉唑与伏立康唑联用不良反应报告1414例,其中以奥美拉唑联用伏立康唑为首要怀疑药物的不良反应报告数为302例。与奥美拉唑单独使用相比,奥美拉唑联用伏立康唑的ROR和PRR都>2的不良反应信号共134种;与伏立康唑单独使用相比,奥美拉唑联用伏立康唑的ROR和PRR都>2的不良反应信号共31种。结论 奥美拉唑与伏立康唑联用相较于单独使用时,不良反应的信号更为显著。因此,在临床应用中建议密切关注联合用药后可能出现的不良反应,及时调整这两种药物的剂量。Objective To explore and evaluate the adverse reaction signals associated with the combination of omeprazole and voriconazole using the FAERS database and to provide a reference for clinical rational drug use.Methods Adverse event reports of omeprazole and voriconazole in the FAERS database were searched from 2004 to 2023,and the ROR and PRR methods of the disproportionality analysis were used to compare the potential adverse reaction signals of omeprazole combined with voriconazole and those of each drug used alone.At the same time,the signals of the adverse drug reactions and the systemic organs involved were compared.Results A total of 1414 adverse reaction reports were included of omeprazole and voriconazole,the number of adverse drug reaetion reports associated with the combination of omeprazole and voriconazole as primary suspected was 302.Compared with omeprazole alone,there were 134 adverse reaction signals with both ROR and PRR>2.Compared with the voriconazole alone,31 adverse reaction signals with both ROR and PRR>2 were found.Conclusion The combination of omeprazole and voriconazole exhibited more significant adverse reaction signals than when either drug was used alone.Therefore,it is recommended to closely monitor potential adverse reactions after combining these two drugs and adjust their dosages as needed in clinical practice.

关 键 词：奥美拉唑 伏立康唑 联合用药 FDA不良事件报告系统 不良反应 

分 类 号：R975.6[医药卫生—药品] R978.5[医药卫生—药学]