中国临床药理学杂志2024，Vol.40Issue(17)：2567-2571,5.DOI:10.13699/j.cnki.1001-6821.2024.17.023
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
摘要
Abstract
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 32 728 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 label 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.关键词
鲁拉西酮/不良事件/信号挖掘/比值失衡测量法/美国食品药品监督管理局不良事件报告系统Key words
lurasidone/adverse event/data mining/proportional imbalance measurement/U.S.Food and Drug Administration Adverse Event Reporting System分类
药学引用本文复制引用
陈玉清,王占璋,朱秀清,杨烨,戴丽静,卢浩扬,宋娥美,温预关..用Open Vigil FDA2.1对鲁拉西酮不良事件信号的分析[J].中国临床药理学杂志,2024,40(17):2567-2571,5.基金项目
广东省药学会临床治疗精准用药专项基金资助项目(2023JZ14,2022JZ34) （2023JZ14,2022JZ34）
广东省医院药学研究基金资助项目(澳美基金2022A22) （澳美基金2022A22）
广东省卫生计生适宜推广基金资助项目(粤卫办函[2018]326号) （粤卫办函[2018]326号）
广东省医学科研基金资助项目(A2024493,A2024771) （A2024493,A2024771）
广州市研究型医院建设单位基金资助项目(穗卫函[2021]1557号) （穗卫函[2021]1557号）
广州市临床重点专科(临床医学研究所)基金资助项目(穗卫函[2023]1719号) （临床医学研究所）
