基于FAERS数据库分析GLP-1受体激动剂相关精神疾病的药物警戒信号

Pharmacovigilance signals mining for the glucagon-like peptide1 receptor agonists related psychiatric disorders based on the FDA adverse event reporting system(FAERS)

目的基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库分析胰高血糖素样肽1(GLP-1)受体激动剂相关精神疾病的药物警戒信号。方法筛选2010年1月至2023年3月FAERS中的药品不良事件(ADEs)报告,收集使用艾塞那肽、利西拉肽、利拉鲁肽、阿必鲁肽、度拉糖肽和司美格鲁肽等6种GLP-1受体激动剂患者的ADEs报告,使用比例失衡法的报告比值比分析精神疾病信号并进行错误发现率校正。结果6种GLP-1受体激动剂的精神疾病信号皆为阴性,但依然存在具有阳性信号的首选术语(PT)。这些PT包括神经紧张不安、挫折承受力降低、注射恐惧、暴食症、一般性疾病引起的睡眠障碍及失眠型睡眠障碍。结论GLP-1受体激动剂相关精神疾病的阳性信号PT可能与药物的治疗作用和患者自身疾病有关。

Objective Pharmacovigilance signals for glucagon-like peptide 1(GLP-1)receptor agonists related psychiatric disorders were mined using FDA adverse event reporting system(FAERS).Methods Adverse drug events(ADEs)reports from January 2010 to March 2023 were screened,and ADEs reports from patients taking six GLP-1 receptor agonists such as Exenatide,Lixisenatide,Liraglutide,Albiglutide,Dulaglutide,and Semaglutide were selected.Psychiatric signals were analyzed using the reporting odds ratio by disproportionality mearsure and false discovery rate correction was conducted.Results There were no positive signals with the six GLP-1 receptor agonists,but positive signals for preferred terms(PT)were found,including:nervousness,reduced frustration tolerance,fear of injection,bulimia,sleep disorder caused by general diseases,and insomnia caused by general diseases.Conclusion Positive signals of PT in GLP-1 receptor agonist related psychiatric disorders may be associated with the therapeutic effect of the drug and the patient's disease.