摘要
目的通过美国食品药品管理局不良事件报告系统(FAERS)数据库挖掘仑卡奈单抗相关不良事件(ADE)的风险信号,为该药临床安全使用提供参考依据。方法检索FAERS中2010年第4季度至2024年第2季度仑卡奈单抗相关ADE报告,采用报告比值比法、综合标准法、贝叶斯置信区间递进神经网络法与多项式伽马泊松分布缩减法进行信号挖掘,对报告频数和信号强度排名前30位以及各系统/器官分类的ADE进行统计分析。结果共收集到仑卡奈单抗相关ADE报告868份,涉及ADE 1986例次,挖掘到相关ADE信号38个,严重ADE占比为23.39%,87.15%的ADE发生在用药后的前3个月。报告例次排名前30位的PT信号主要为头痛、畏寒、疲劳、渗出型淀粉样蛋白相关成像异常(ARIA-E)、出血型淀粉样蛋白相关成像异常(ARIA-H)等,信号强度排名前30位的主要包括ARIA-E、ARIA-H、脑雾、输液相关反应等,神经系统疾病相关ADE最为常见。挖掘出15种未被药品说明书记载的ADE,如脑雾、蚁行感、癫痫持续状态等。结论临床使用仑卡奈单抗前应做好患者用药风险评估,用药期间尤其是前3个月,应重点监测ARIA-E、ARIA-H、输液相关反应等常见ADE,同时也需要关注新发现可疑的ADE,保证患者用药安全。
Objective To mine the risk signals of adverse drug events(ADEs)related to lecanemab through the U.S.Food and Drug Adminstration Adverse Event Reporting System(FAERS)database,to provide a reference for the safe clinical use of lecanemab.Methods Data on adverse events related to lecanemab from the fourth quarter,2010 to the second quarter 2024 in the FAERS were collected.Potential ADE signals were mined using the reporting odds ratio(ROR)method,Medicines and Healthcare Products Regulatory Agency(MHRA)method,Bayesian confidence propagation neural network(BCPNN)method and multi-item gamma Poisson shrinker(MGPS)method.The top 30 ADEs in terms of report frequency and signal strength,as well as ADEs categorized by system organ class(SOC),were statistically analyzed.Results A total of 868 adverse event reports related to lecanemab were collected,involving 1,986 instances of ADEs with 38 related ADE identified,the proportion of serious ADEs was 23.39%,and 87.15%of ADEs occurred in the first 3 months after the initiation of the drug.The top 30 PT signals in reported cases were headache,chills,fatigue,effusion type amyloid-related imaging abnormalities(ARIA-E),hemorrhage-type amyloid-related imaging abnormalities(ARIA-H),and so on.The top 30 signals in terms of signal intensity mainly included ARIA-E,ARIA-H,brain fog,infusion-related reactions.ADEs related to nervous system diseases were the most common.Fifteen new suspected or serious ADEs not recorded in the instructions were discovered,such as brain fog,formication,status epilepticus.Conclusion Risk assessment of patients'medication should be conducted before clinical use of lecanemab,especially in the first 3 months of the medication period,focus should be placed on monitoring common ADEs,such as ARIA-E,ARIA-H,infusion-related reactions.Attention also needs to be paid to the newly discovered suspected ADEs,to ensure the patients'medication safety.
作者
张雯
李敏
刘二平
陶文婷
蔡瑞
周伟贤
ZHANG Wen;LI Min;LIU Erping;TAO Wenting;CAI Rui;ZHOU Weixian(Department of Pharmacy,Changzhou Maternal and Child Health Care Hospital,Changzhou 213000,Jiangsu Province,China;Department of Pharmacy,The First People's Hospital of Changzhou,Changzhou 213000,Jiangsu Province,China)
出处
《药物流行病学杂志》
2025年第2期166-174,共9页
Chinese Journal of Pharmacoepidemiology
基金
江苏省药学会—石药医院药学科研基金(SY202301-3)
常州市科技计划项目(CJ20239025,CJ20219024)。
