基于FAERS数据库的奥马珠单抗不良事件信号挖掘  

Omalizumab adverse event signal mining based on FAERS database

作　　者：卢妤[1] 廖兆豪 任冠桦[1] 吴四智 马为[2] LU Yu;LIAO Zhaohao;REN Guanhua;WU Sizhi;MA Wei(Department of Pharmacy,Guangzhou First People’s Hospital,Guangzhou 510180,China;Department of Geriatrics Respiratory Medicine,Guangzhou First People’s Hospital,Guangzhou 510180,China)

机构地区：[1]广州市第一人民医院药剂科,广东广州510180 [2]广州市第一人民医院老年呼吸内科,广东广州510180

出　　处：《广州医药》2024年第5期478-488,共11页Guangzhou Medical Journal

基　　金：国家自然科学基金资助项目(82204811);广州市科学技术局重点研发计划项目(202206010099)。

摘　　要：目的运用数据挖掘的方法检测奥马珠单抗上市后的不良反应信号,为临床安全合理用药提供参考。方法本研究采用报告比值比法(ROR)和贝叶斯判别可信区间递进神经网络法(BCPNN)对美国FDA不良事件报告系统(FAERS)中2004年第1季度至2023年第2季度的奥马珠单抗相关不良事件(ADE)报告进行数据挖掘和信号检测。结果通过数据挖掘和信号检测,涉及奥马珠单抗的ADE报告中提取了186,353份报告,涉及45,383例患者。在这些报告中,女性(65.31%)比例远高于男性(24.97%)。主要报告国家为美国(64.93%)和加拿大(11.96%)。报告者中以消费者(41.35%)和医师(36.97%)为主要群体。研究发现了621个ADE阳性信号,涉及25个系统器官分类(SOC),主要包括呼吸系统、胸部和纵隔疾病(21.29%)以及感染和侵染类疾病(10.91%)。其中,183个信号被评定为高风险信号,其中包括57个新的高风险信号,如血压升高、易醒型失眠和心律失常等。这些发现有助于更全面地了解奥马珠单抗的安全性和潜在风险。结论在奥马珠单抗的临床应用过程中,除了要注意药品说明中提到的已知不良反应外,还需特别警惕潜在的不良药物事件,如血压升高、心率升高、中间易醒型失眠、体位性心动过速综合征等。Objective To use data mining method to detect the adverse reaction signal of omalizumab after marketing,and to provide reference for clinical safety and rational drug use.Methods In this study,the report odds ratio method(ROR)and Bayesian confidence propagation neural network(BCPNN)were used to conduct data mining and signal detection for omalizumabrelated adverse event(ADE)reports from the FDA Adverse Event Reporting System(FAERS)from the first quarter of 2004 to the second quarter of 2023.Results Through data mining and signal detection,186,353 reports of ADE involving omalizumab were extracted,involving 45,383 patients.Among these reports,the proportion of women(65.31%)was much higher than that of men(24.97%).The main reporting countries were the United States(64.93%)and Canada(11.96%).consumers(41.35%)and doctors(36.97%)were the main groups of reporters.The study identified 621 ADE positive signals across 25 system organ classes(SOCs),including respiratory,chest,and mediastinal diseases(21.29%)and infectious and infectious diseases(10.91%).Of these,183 signals were assessed as high risk,including 57 new high-risk signals.These findings contribute to a more complete understanding of the safety and potential risks of omalizumab.Conclusions In the clinical application of omalizumab,in addition to the known adverse reactions mentioned in the drug description,special attention should be paid to potential adverse drug events,such as elevated blood pressure,elevated heart rate,intermediate insomnia,and postatic tachycardia syndrome.

关 键 词：奥马珠单抗 药品不良事件 信号挖掘 合理用药 药品不良反应 

分 类 号：R969.3[医药卫生—药理学]