摘要
目的挖掘司库奇尤单抗和依奇珠单抗的不良事件(ADE)信号,为两药的临床安全使用提供参考。方法应用比值失衡法中的报告比值比法(ROR)和比例报告比值法(PRR)对美国食品药品管理局(FDA)不良事件报告系统(FDA adverse event reporting system,FAERS)中司库奇尤单抗和依奇珠单抗2017年第一季度至2020年第四季度共16个季度的ADE进行数据挖掘及分析。结果经计算及二次筛选后得到司库奇尤单抗ADE信号152个,依奇珠单抗ADE信号68个,其中有12个信号为司库奇尤单抗和依奇珠单抗的重叠信号。两药所得ADE信号与已知的相关安全性信息基本一致,主要涉及感染及侵染类疾病、全身性疾病及给药部位各种反应等方面。并发现药品说明书有收录不全之处及两药ADE的不同之处,提示临床应注意根据患者个体情况选择用药。结论基于FAERS数据库对司库奇尤单抗和依奇珠单抗上市后的ADE信号进行挖掘和分析,能为临床安全用药提供参考。
Objective To explore the adverse event(ADE)signals of secukinumab and ixekizumab,and to provide a reference for the safe clinical use of two drugs.Methods The reported ratio method(ROR)and proportional report ratio method(PRR)in disproportionality analysis methods were used to mine and analyze the ADE of secukinumab and ixekizumab in FDA adverse event reporting system(FAERS)in 16 quarters from the first quarter of 2017 to the fourth quarter of 2020.Results After the calculation and secondary screening,152 ADE signals of secukinumab and 68 ADE signals of ixekizumab were obtained,among which 15 signals were overlapping signals of secukinumab and ixekizumab.ADE signals obtained by the two drugs are basically consistent with the known safety information,mainly involving infection and infectious diseases,skin and subcutaneous tissue diseases,etc.However,it is also found that there are some incompleteness in drug instructions and differences between ADE and ADE,which suggest that we should pay attention to the selection of drugs according to individual conditions of patients.Conclusion Based on FAERS database,the ADE signals of secukinumab and ixekizumab after marketing are mined and analyzed,which can provide a reference for drug safety in clinical practice.
作者
刘小英
王浩
阳丽
陈力
LIU Xiaoying;WANG Hao;YANG Li;CHEN Li(Department of Pharmacy,Xindu District People's Hospital of Chengdu,Chengdu 610500,China;Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children(West China Second University Hospital,Sichuan University),Chengdu 610041,China)
出处
《医药导报》
CAS
北大核心
2022年第4期572-578,共7页
Herald of Medicine
