基于FDA不良事件报告系统数据库的伊伐布雷定不良反应信号比值失衡分析  

Analysis of proportional imbalances in adverse reaction signals of ivabradine based on the FDA adverse event reporting system database

作　　者：段萌 刘金 刘楠楠[2] 关笑婵 DUAN Meng;LIU Jin;LIU Nannan;GUAN Xiaochan(Department of Pharmacy,the First People's Hospital of Dongcheng District,Beijing 100075,China;Department of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China;Department of Pharmacy,Beijing Yanhua Hospital,Beijing 102500,China)

机构地区：[1]北京市东城区第一人民医院药剂科,北京100075 [2]中日友好医院药学部,北京100029 [3]北京燕化医院药剂科,北京102500

出　　处：《临床药物治疗杂志》2024年第12期54-59,共6页Clinical Medication Journal

摘　　要：目的通过检索FDA不良事件报告系统(FAERS)数据库中的伊伐布雷定不良反应上报数据进行信号评价,为伊伐布雷定安全用药提供参考。方法使用OpenVigil 2.1平台检索FAERS数据库中的伊伐布雷定不良反应报告数据,检索时间为2004年1月1日至2023年12月30日,通过报告比值比(ROR)法对数据挖掘分析。结果共检索到以伊伐布雷定为主要及次要怀疑药物的ADR报告2829份,阳性信号196个,共4130例次。检测结果涉及22个系统器官分类(SOC),主要为各类损伤、中毒及操作并发症、心脏器官疾病等。药品说明书中未提及的SOC包括精神病类、内分泌系统疾病、感染及侵染类疾病。妊娠期相关ADR共24例,信号较强的包括妊娠早期(ROR=2593.984)、羊水过多(ROR=46.815)、过大儿(ROR=44.088)。结论伊伐布雷定心脏相关ADR上报数量最多,但多与患者疾病相关。应注意妊娠期使用伊伐布雷定可能存在的致畸风险,若其他药物无法代替,应定期进行超声检查。除已知的ADR,精神系统类ADR阳性信号较强,需引起临床关注。Objective By retrieving the adverse event reporting data of ivabradine from the FDA adverse event reporting system(FAERS)database and conducting a data signal evaluation,this study aims to provide references for the safe use of ivabradine.Methods The reporting data of ivabradine within the FAERS database were retrieved by employing the OpenVigil 2.1 platform.The retrieval time spanned from January 1st,2004 to December 30th,2023.Subsequently,data mining and analysis were conducted using the reporting odds ratio(ROR)method.Results A total of 2829 ADR reports were retrieved,with ivabradine being the primary or secondary suspected drug.Among them,196 positive signals were identified,involving a total of 4130 case.The detection results covered 22 SOC,mainly including various injuries,poisonings,and operative complications,as well as cardiovascular diseases.ADR not mentioned in the drug instructions included psychiatric disorders,endocrine system diseases,and infectious and parasitic diseases.There were 24 cases related to pregnancy,with relatively strong signals such as early pregnancy(ROR=2593.984),polyhydramnios(ROR=46.815),and macrosomia(ROR=44.088).Conclusion Ivabradine has the highest number of ADE reports related to the heart,yet most are associated with patients'preexisting diseases.Attention should be paid to the potential teratogenic risks of using ivabradine during pregnancy.If no alternative drugs are available,regular ultrasound examinations should be carried out.In addition to the known ADR,the positive signals of psychiatric ADR are relatively strong and thus require close monitoring.

关 键 词：伊伐布雷定 信号挖掘 FDA不良事件报告系统数据库 妊娠期安全性 

分 类 号：R972.2[医药卫生—药品]