摘要
目的利用大样本数据对依洛尤单抗和阿利西尤单抗的不良事件(ADE)进行信号挖掘分析,为临床合理安全用药提供参考。方法收集美国食品药品管理局不良事件报告系统(FAERS)中2015年第3季度—2021年第2季度共24季度的依洛尤单抗和阿利西尤单抗的ADE报告,采用报告比值比(ROR)法和比例报告比值(PRR)法对其进行数据挖掘。利用《国际医学用语词典》(MedDRA)对药物不良事件信号进行标准化分析。结果共收集不良事件报告8024207份,筛选出相关的ADE报告73797份,其中依洛尤单抗报告61883例,阿利西尤单抗报告11914例,男女比例0.74:1,年龄集中在45~74岁。挖掘到依洛尤单抗和阿利西尤单抗相关ADE信号主要集中在注射部位反应、骨骼肌肉系统疾病以及呼吸系统疾病等方面,且依洛尤单抗在骨骼肌肉系统疾病及呼吸系统疾病相关ADE具有更高风险。将信号进行规整比对,还挖掘出了神经系统疾病等药品说明书中尚未收录的关联较强的ADE信号。结论利用FAERS数据库可较深入挖掘分析依洛尤单抗和阿利西尤单抗的安全警示信号,为临床安全合理选择用药提供参考。
Objective To analysis the adverse drug event(ADE)of evolocumab and alirocumab by signal mining using large sample scale data,and to provide a reference for rational and safe drug use in clinic.Methods ADE reports of evolocumab and alirocumab from the 3rd quarter of 2015 to the 2nd quarter of 2021 were collected from the FDA adverse event reporting system(FAERS),and data mining was performed by reported odds ratio(ROR)and proportional reporting ratio(PRR)methods.The Medical Dictionary for Drug Regulatory Activities(MedDRA)was used for the standardized analysis of adverse drug event signals.Results Among 8024207 adverse reaction reports collected,73797 ADE reports were screened out,including 61883 cases of evolocumab and 11914 cases of alirocumab,with a male to female ratio of 0.74 to 1,aged from 45 to 74 years old.It was found that ADE signals related to evolocumab and alirocumab were mainly concentrated on injection site reaction,skeletal muscle disease,and respiratory disease.Evolocumab had a higher risk of skeletal muscle disease and respiratory disease-related ADE.The signals were normalized and compared;ADE signals with a strong correlation which have not been included in drug instructions,such as neurological diseases,were also discovered.Conclusion FAERS database can be used to excavate and analyze safety warning signals of evolocumab and alirocumab,providing a reference for clinical safety and rational drug selection.
作者
刘少华
蒋王艳
阮晨
陶婧雯
郭洁茹
刘喆隆
樊静静
LIU Shaohua;JIANG Wangyan;RUAN Chen;TAO Jingwen;GUO Jieru;LIU Zhelong;FAN Jingjing(Department of Endocrinology,Subcenter of National Clinical Research Center for Metabolic Diseases,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Cardiology,Cardiac Function Examination Center,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Department of Pharmacy,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China)
出处
《医药导报》
CAS
北大核心
2023年第1期121-126,共6页
Herald of Medicine
基金
湖北省卫生健康委面上项目(WJ2021M106)。
