基于FAERS数据库的喹硫平不良事件信号挖掘与分析

Data mining of adverse drug event signals for quetiapine based on FAERS database

目的基于美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库挖掘喹硫平的药物不良事件(ADE)信号,为该药的临床安全使用提供参考。方法检索FAERS数据库中2004年至2023年共79个季度关于喹硫平的不良反应报告,同时采用报告比值比法、比例报告比值法、贝叶斯置信区间神经网络传播法、多重伽马-泊松收缩估计法,按药物不良事件术语集的首选术语(PT)和系统器官分类(SOC)对纳入的ADE报告进行分类并计算风险信号。结果共收集主要怀疑药物为喹硫平的ADE报告261725份,涉及的患者有68012例,其中以女性(37495份,55.13%)及老年患者(>65岁)(35312份,占51.9%)居多,报告国家以美国为主,结局多为其他严重后果、住院、死亡和危及患者生命。共挖掘出喹硫平阳性风险信号PT 713个,涉及SOC 27个,所得信号基本与药品说明书一致,其中报告数最多的ADE为糖尿病,且信号强度较高。报告数超过500例的ADE中,共挖掘47个阳性风险信号PT,其中横纹肌溶解为说明书中未收载的ADE。喹硫平引起ADE发生的时间不一,常在用药后30 d内或用药一年以上发生。结论临床在使用喹硫平时除应在全程关注药品说明书收录的ADE外,还应警惕说明书未提及的ADE,并且根据性别、年龄等制订个体化的用药监护方案。

Objective To mine adverse drug event(ADE)signals for quetiapine from the FDA Adverse Event Reporting System(FAERS)database,and provide reference for its safe clinical use.Methods We searched the FAERS database for ADE reports related to quetiapine from 2004 to 2023,79 quarters in total.Several methods were used,including the reporting odds ratio,proportional reporting ratio,Bayesian confidence propagation neural network,and multi-item Gamma poisson shrinker.The ADE reports were categorized and risk signals were grouped based on the preferred terms and system organ classes.Results Totally 261725 ADE reports were collected in which quetiapine was the primary suspect drug,involving 68012 patients.The majority of these reports came from females(37495 reports,55.13%)and over 65 years old(35312 reports,51.9%),mainly reported in the United States,with outcome often being other serious consequences,hospitalization,death,or life-threatening conditions.Totally 713 positive risk signals for quetiapine were identified,covering 27 system organ classes,basiclly consistent with the insruction in the drug package.The most frequently reported ADE was diabetes,with strong signals.Among those ADEs with more than 500 reports,47 positive risk signals were identified,except rhabdomyolysis,which was not listed in the instruction.The time of ADEs onset induced by quetiapine varied,often occurring within 30 days or a year after the treatment.Conclusion Clinicians should not only monitor the ADEs of quetiapine in the instuction but also be vigilant about those not mentioned.Individualized monitoring plans should be catered based on factors such as gender and age.