某市静脉及口服铁剂不良事件信号挖掘和分析  

Signal mining and analysis of adverse drug events of intravenous and oral iron preparations in some city

作　　者：马思佳 李兴桥 MA Si-jia;LI Xing-qiao(Chengdu Institute for Drug Control,Chengdu 610000,China)

机构地区：[1]成都市药品检验研究院,成都610000

出　　处：《中国新药杂志》2025年第4期444-448,共5页Chinese Journal of New Drugs

摘　　要：目的:挖掘和评价静脉及口服铁剂药品不良事件(adverse drug event,ADE)信号,为临床合理用药提供参考。方法:基于2011年1月1日—2023年12月31日期间国家药品不良反应监测系统成都数据库收集的蔗糖铁注射液、右旋糖酐铁注射液、多糖铁复合物及琥珀酸亚铁相关药品不良反应报告,采用报告比值比法(reporting odds ratio,ROR)对数据进行信号挖掘及分析。结果:通过信号检测方法共挖掘出36个ADE信号,蔗糖铁注射液及右旋糖酐铁注射液关联强度高的ADE主要涉及注射部位反应、全身性给药反应、呼吸系统、胸及纵隔疾病及过敏反应等。多糖铁复合物及琥珀酸亚铁关联性强的ADE主要为胃肠系统损害。结论:4种铁剂ADE累及器官/系统具有差异性,对数据进行分析可以为临床药品选择提供帮助。Objective:To provide reference for clinical safe drug use by signal mining and analysis of adverse drug events(ADEs)of intravenous and oral iron preparations.Methods:Based on the reports in Chengdu database of the National Adverse Drug Reaction Monitoring System from the first quarter of 2011 to the fourth quarter of 2023,the adverse drug reaction signals produced by iron sucrose injection,iron dextran injection,polysaccharide iron complex,and ferrous succinate were mined.The reporting odds ratio(ROR)method was used to mine and analyze the related data.Results:Thirty-six ADE signals were found by ROR signal detection method,which had high correlation strength between iron sucrose injection and iron dextran injection,mainly involving injection site reaction,systemic administration reaction,disease of respiratory system and allergic reaction.However,polysaccharide iron complex and ferrous succinate-related ADEs were mainly associated with gastrointestinal damage.Conclusion:The organs/systems involved with the ADE signals of four kinds of iron preparations are different,and the analysis of the data can provide help for clinical drug selection.

关 键 词：静脉铁剂 口服铁剂 比例失衡法 信号挖掘 药品不良事件 

分 类 号：R969.3[医药卫生—药理学]