基于美国FDA不良事件报告系统数据库分析伏诺拉生的药物不良事件  

Analytical study of adverse drug events of vonoprazan based on FAERS

作　　者：唐静 毛戈 TANG Jing;MAO Ge(Department of Pharmacy,Liyuan Hospital,Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430077,China;Department of Information and Statistics Department,Liyuan Hospital,Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430077,China)

机构地区：[1]华中科技大学同济医学院附属梨园医院药剂科,武汉430077 [2]华中科技大学同济医学院附属梨园医院统计信息科,武汉430077

出　　处：《中国新药杂志》2024年第2期198-203,共6页Chinese Journal of New Drugs

摘　　要：目的:基于美国FDA不良事件报告系统(FDA Adverse Event Reporting System,FAERS)对伏诺拉生引起的药物不良事件进行信号挖掘分析,对其安全性进行评判,以期为医疗机构安全用药提供参考.方法:选取FAERS数据库2016年—2022年2季度的数据,对照《ICH国际医学用语词典》(medical dictionary for regulatory activities,MedDRA)不良事件编码,处理数据后,提取以伏诺拉生为首要怀疑药品的不良事件报告,通过报告比值法(reporting odds ratio,ROR)和比例报告比值比法(proportional reporting ratio,PRR)监测信号.结果:提取以伏诺拉生为首要怀疑药品的不良事件报告病例共987例,男女比例为1.33,平均年龄为65.33岁;医师上报的数量为68.90%;94.63%的报告来自日本.伏诺拉生产生不良事件较多的主要集中在胃肠疾病系统、全身性疾病及给药部位各种反应、各类检查、呼吸系统、胸及纵隔疾病系统、心脏器官疾病系统.结论:通过FAERS数据库伏诺拉生不良反应的挖掘分析,提高了对这类在我国上市不久、用药经验欠缺的药品安全认识,为临床实际用药提供帮助.Objective:To explore the safety of vonoprazan by collecting the adverse events of FDA Adverse Event Reporting System(FAERS)and provide reference for its safe use in clinic.Methods:The FAERS data of vonoprazan from 2016 to 2022Q2 were downloaded and matched with MedDRA adverse event system.The adverse event reports with vonoprazan as the primary suspect drug were extracted,and the adverse event signals were detected utilizing reporting odds ratio(ROR)and proportional reporting ratio(PRR).Results:A total of 987 adverse drug event reports with vonoprazan as the primary suspect drug were obtained.The male/female ratio was 1.33,and the median age was 65.33 years old.Reports from"doctor"accounted for 68.90%,and 94.63%reports were from Japan.The top five system organ classes(SOCs)were gastrointestional disease,general disorders and administration site conditions,various examinations,chest and mediastinal diseases and cardiac disorders causing by vonoprazan.Conclusion:Through analysis of the adverse reactions of vonoprazan in the FAERS database,it may be helpful to provide important information on the safety of vonoprazan.

关 键 词：伏诺拉生 美国FDA不良事件报告系统数据库 药物不良事件 信号挖掘 

分 类 号：R969.3[医药卫生—药理学]