基于FAERS数据库儿童应用奥马珠单抗安全信号挖掘与分析

目的:分析探究奥马珠单抗在儿童患者中潜在的不良事件(adverse drug event,ADE),为临床合理用药提供数据支持。方法:通过对美国食品药品监督管理局不良事件呈报系统(FDA Adverse Event Reporting System,FAERS)相关数据进行挖掘,分别应用报告比值比法(reporting odds ratio,ROR)和比例报告比值比法(proportional reporting ratio,PRR)对儿童使用奥马珠单抗的不良事件信号进行分析研究。结果:研究表明儿童奥马珠单抗不良事件多见于呼吸系统、免疫系统、胃肠系统及各类检查值异常,发现心率异常、耳充血等ADE在该药品说明书中未见阐述。性别和临床适应证与严重过敏反应的发生可能具有一定的相关性,临床需引起高度关注。结论:儿童在应用该药前应重视过敏反应风险评估、关注疾病进展及心血管不良事件的关系。特别是对于患有哮喘或具有既往过敏史的女童应加强药学监护,对存在血栓栓塞疾病危险因素的患者更须提高警惕。

Safety signal mining and analysis for omalizumab used in children base on FAERS database

OBJECTIVE To explore the potential adverse drug events (ADEs) of omalizumab used in pediatric patients, so as to provide data support for clinical rational drug use.METHODS The related data were mined based on FDA Adverse Event Reporting System (FAERS), and the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) were used to analyze the ADEs signal of omalizumab used in pediatric patients.RESULTS The studies showed that the adverse events of omalizumab in children were more common in the respiratory system, immune system, gastrointestinal system, and various examination values were abnormal. Abnormal heart rhythm and ear congestion were not listed in the drug instruction. Sex, clinical indications and the occurrence of severe allergic reactions may have some correlation, which should be paid high clinical attention.CONCLUSION Before the application of omalizumab, more attention should be paid to anaphylaxis risk assessment, and the relationship between disease progression and adverse cardiovascular events. Especially for girls with asthma or a history of allergies, pharmacy monitoring should be strengthened, and more vigilance is needed for patients with risk factors for thromboembolic disease.