用Open Vigil FDA2.1对鲁拉西酮不良事件信号的分析

Analysis of adverse events signaling of lurasidone by Open Vigil FDA2.1

目的用Open Vigil FDA2.1对美国食品药品监督管理局不良事件呈报系统(FAERS)数据库中鲁拉西酮的相关数据进行分析,探究该药不良事件的发生情况,为我国临床用药丰富经验,提供依据。方法用Open Vigil FDA2.1提取FAERS数据库中2010年第四季度至2023年第三季度关于鲁拉西酮的不良事件数据,用报告比值比(ROR)法与比例报告比(PRR)法进行数据挖掘与分析。结果共得到32728份以鲁拉西酮为首要怀疑药物的不良事件报告,其中女性占比较大(54.26%),且多发生在成年人(18~59岁)。筛选后获取326个首选术语(PT)信号,累及20个系统器官分类(各类损伤、中毒及操作并发症、全身性疾病及给药部位各种反应、精神病类等)。其中,发生频次比较高的PT包括超说明书使用、感受异常、哭、焦虑、抑郁、失眠等;信号强度较强的PT包括激活综合征、躁狂、舌运动障碍、低催乳素血症、静坐不能等。挖掘到多个新的可疑药物不良反应,包括低催乳素血症、情绪贫乏、强硬舌等。结论鲁拉西酮的安全性较佳,女性服用该药时,需密切关注催乳素水平。妊娠期、产褥期及围生期女性及代谢功能不佳的患者使用该药相对安全。低催乳素水平、不宁腿综合征是鲁拉西酮新的罕见的可疑不良事件。

Objective To investigate the occurrence of adverse events of lurasidone in the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database by using Open Vigil FDA2.1,to enrich the experience and provide the basis for the clinical use of the drug in China.Methods Using Open Vigil FDA2.1,adverse event data were extracted from the FAERS database for a total of 51 quarters from the 4th quarter of 2010 to the 3rd quarter of 2023,and the ratio of reporting ratio(ROR)method and the proportional reporting ratio(PRR)method were used for data mining and analysis.Results A total of 32728 adverse event reports with lurasidone as the first suspected drug was obtained,with a larger proportion of females(54.26%)and occurring mostly in adults(18 to 59 years).After the screening,326 preferred term(PT)signals were obtained,involving 20 system-organ classifications(injury,poisoning and procedural complications,general disorders and administration site conditions,psychiatric disorders,etc.).Among them,PTs with the higher frequency of occurrence included off lab el use,feeling abnormal,crying,anxiety,depression,insomnia,etc.PTs with stronger signal strength included activation syndrome,mania,tongue movement disturbance,hypoprolactinaemia,akathisia,etc.Multiple new suspected adverse drug reactions were unearthed,including hypoprolactinaemia,emotional poverty,stiff tongue,etc.Conclusion Lurasidone has a favorable safety profile,and women need to closely monitor prolactin levels when taking this medication.The drug is relatively safe for use in pregnant,puerperal and perinatal women and patients with poor metabolic function.Hypoprolactinaemia and restless leg syndrome are new rare suspected adverse events with lurasidone.