基于FAERS的5-羟色胺和去甲肾上腺素再摄取抑制剂不良事件信号挖掘  

Excavation of adverse event signals of serotonin-norepinephrine reuptake inhibitor based on FAERS

作　　者：蒋啸 宋伟 郭咸希[1] 谭娟 汤柳 JIANG Xiao;SONG Wei;GUO Xian-xi;TAN Juan;TANG Liu(Department of Pharmacy,Renmin Hospital of Wuhan University,Wuhan 430060,China)

机构地区：[1]武汉大学人民医院药学部,湖北武汉430060

出　　处：《现代药物与临床》2023年第11期2855-2860,共6页Drugs & Clinic

基　　金：中央高校基本科研业务费专项资金资助项目(2042022kf1077);湖北省卫生健康委员会面上项目(WJ2021M147);湖北省自然科学基金资助项目(2023AFB239)。

摘　　要：目的 挖掘5-羟色胺和去甲肾上腺素再摄取抑制剂相关不良事件的风险信号,为该类药物的临床安全使用提供参考。方法 利用美国食品药品监督管理局不良事件报告系统(FAERS)数据库,使用OpenVigil 2.1数据平台,收集文拉法辛、度洛西汀、左旋米那普仑从FAERS建库或在美国上市至2023年6月30日的不良事件报告。采用报告比值比法(ROR)联合贝叶斯可信区间递进神经网络法(BCPNN)进行数据挖掘,并分别按照发生频次和信号强度进行排序。结果 共检索到相关不良事件报告9 376份,风险信号1 419个,其中文拉法辛(4 564份,791个)、度洛西汀(4 411份,585个)、左旋米那普仑(401份,43个)。按发生频次排序,文拉法辛和度洛西汀发生频次较多的停药综合征、恶心、头晕以及左旋米那普仑发生频次较多的血压升高、多汗等均可见于其药品说明书;从信号强度来看,文拉法辛对子代的影响、度洛西汀与文拉法辛共有的低钠血症以及左旋米那普仑的肾功能损害都是相关性较强并且罕见的不良事件。结论 临床在使用上述药物时,应关注患者的电解质水平、肾功能、精神异常以及妊娠周期和状态,若发生相关不良事件,应及时采取干预措施,以保障患者用药安全。Objective To excavate the risk signals of adverse events related to serotonin-norepinephrine reuptake inhibitor (SNRI), and to provide reference for clinical safe use of these drugs. Methods Using the FDA adverse event reporting system (FAERS) database and OpenVigil 2.1 data platform, the adverse events reports for venlafaxine, duloxetine, and levomilnacipran were collected from FAERS established the database or approved by FDA to the June 30th, 2023. The ROR method combined with BCPNN was used for data mining and sorted according to the occurrence frequency and signal strength respectively. Results A total of 9 376 adverse events reports related to SNRI were retrieved, with 1 419 risk signals, including venlafaxine (4 564 reports, 791 signals), duloxetine (4 411 reports, 585 signals) and levomilnacipran (401 reports, 43 signals). According to the occurrence frequency, withdrawal syndrome, nausea and dizziness which occur more frequently with venlafaxine and duloxetine, as well as elevated blood pressure and excessive sweating, which occur more frequently with levomilnacipran, can be found in their drug instructions. According to the signal strength, the effects of venlafaxine on infants and children, the hyponatremia shared by duloxetine and venlafaxine, and the renal impairment of levomilnacipran are all highly relevant and rare adverse events reports. Conclusion When SNRIs were used clinically, the electrolyte levels, renal function, psychiatric abnormalities and pregnancy cycle of patients should be paid attention to. If related adverse events occurred, timely intervention measures should be taken to ensure the medication safety of patients.

关 键 词：5-羟色胺和去甲肾上腺素再摄取抑制剂 不良事件 信号挖掘 抑郁症 文拉法辛 度洛西汀 左旋米那普仑 

分 类 号：R971[医药卫生—药品]