基于FAERS数据库的鲁拉西酮不良事件信号分析

Data analysis of adverse events signals for lurasidone based on FAERS database

目的通过挖掘美国FDA不良事件呈报系统(FAERS)数据库中鲁拉西酮的相关数据,探究该药不良事件发生情况,为临床安全用药提供依据。方法提取FAERS数据库中2010年第4季度至2022年第3季度共48个季度的不良事件数据,采用报告比值比法(ROR)和比例报告比值比法(PRR)进行信号挖掘。结果共得到13302份以鲁拉西酮为首要怀疑药物的不良事件报告,分析得到2155个首选术语(PT)信号,信号累及21个系统器官分类(SOC)。最主要的不良事件是精神病性系统相关表现(如失眠、躁狂、激越等)以及锥体外系反应。结论临床应用鲁拉西酮时,需密切关注患者的体征表现,尤其是出现精神病性症状时,应及时采取措施,保证治疗安全有效。此外,鲁拉西酮引发锥体外系风险仍不容忽视,尤其是静坐不能,应及早发现、及时处理,提高临床用药安全性。

Objective To evaluate the adverse events of lurasidone and provide guidance for the safe use through mining and analyzing US FDA Adverse Event Reporting System(FAERS)database.Methods The data of adverse events in the FAERS database from the 4th quarter of 2010 to the 3rd quarter of 2022(48 quarters)were extracted,and the signal mining was performed by the reporting odds ratio(ROR)and proportional reporting ratio(PRR)method.Results Totally 13302 reports on adverse event with lurasidone as the primary suspected drug were obtained,which involved 2155 preferred term(PT)signals and 21 system organ classes(SOC).The main adverse effects were psychotic system-related manifestations(e.g.,insomnia,mania,agitation,etc.)and extrapyramidal reactions.Conclusion Clinical application of lurasidone requires close attention to the manifestation of patients′signs,especially the appearance of psychotic symptoms,and timely measures should be taken to ensure the effectiveness and safety of treatment.In addition,the risk of extrapyramidal system induced by lurasidone still cannot be ignored,especially the inability to sit still,which should be detected early and treated promptly to improve the safety of clinical drug use.