依洛尤单抗和阿利西尤单抗致神经认知不良事件的风险分析  

Analysis of the risk of neurocognitive adverse events caused by evolocumab and alirocumab

作　　者：郭茜[1] 郭慧 尹冬虹[1] GUO Qian;GUO Hui;YIN Donghong(Dept.of Pharmacy,Second Hospital of Shanxi Medical University,Taiyuan 030001,China;Dept.of Pharmacy,Shanxi Cardiovascular Hospital,Taiyuan 030024,China)

机构地区：[1]山西医科大学第二医院药学部,太原030001 [2]山西省心血管病医院药学部,太原030024

出　　处：《中国药房》2022年第19期2393-2397,共5页China Pharmacy

基　　金：山西省软科学研究项目(No.2016042008-6)。

摘　　要：目的对依洛尤单抗和阿利西尤单抗致神经认知的不良事件报告进行分析,为临床安全用药提供参考。方法提取2015年7月1日至2020年9月30日美国FDA不良事件报告系统(FAERS)中依洛尤单抗和阿利西尤单抗的神经认知不良事件报告,神经认知不良事件使用高位组语进行识别。采用报告比值比(ROR)法,根据报告数≥3且ROR的95%置信区间(95%CI)下限>1的设定,评价以上2种药物与神经认知障碍的相关性。结果分别获得依洛尤单抗和阿利西尤单抗不良事件报告71849份和13171份,其中神经认知不良事件报告分别为1425份(1.98%)和405份(3.07%)。依洛尤单抗、阿利西尤单抗致神经认知不良事件的ROR(95%CI)分别为0.610(0.579,0.643)、0.931(0.844,1.028)。依洛尤单抗筛选出1个信号(记忆障碍),阿利西尤单抗筛选出3个信号(记忆障碍、健忘症、认知障碍)。结论依洛尤单抗和阿利西尤单抗与神经认知不良事件无相关性。OBJECTIVE To analyze the reports of neurocognitive adverse events caused by evolocumab and alirocumab,so as to provide reference for clinical safe drug use.METHODS From July 1,2015 to September 30,2020,the neurocognitive adverse event reports of evolocumab and alirocumab in the FDA adverse event reporting system(FAERS) were extracted,and the neurocognitive adverse events were identified using high-level phrases.The reported odds ratio(ROR)method was used to evaluate the correlation between the above two drugs and neurocognitive impairment according to the setting of the number of reports ≥3and the lower limit of the 95% confidence interval(95%CI)of ROR >1.RESULTS Totally 71 849 and 13 171 reports of adverse events were obtained for evolocumab and alirocumab respectively,of which 1 425(1.98%)and 405(3.07%)were reported for neurocognitive adverse events.ROR(95%CI)of neurocognitive adverse events caused by evolocumab and alirocumab were 0.610(0.579,0.643)and 0.931(0.844,1.028),respectively.One signal(memory impairment)was screened by evolocumab,and three signals(memory impairment,amnesia and cognitive impairment)were screened by alirocumab.CONCLUSIONS There is no risk of neurocognitive impairment in patients receiving evolocumab and alicizumab.

关 键 词：依洛尤单抗 阿利西尤单抗 神经认知 FDA不良事件报告系统 报告比值比法 

分 类 号：R969.3[医药卫生—药理学]