基于FAERS数据库拉贝洛尔不良事件信号挖掘  

Labetalol adverse event signal mining based on FAERS database

作　　者：张晴 苏长海[1] 朱磊[2] 田宜玄 唐海浪[1] 董利森[1] ZHANG Qing;SU Chang-hai;ZHU Lei;TIAN Yi-xuan;TANG Hai-lang;DONG Li-sen(Pharmacy Department of Ordos Central Hospital,Ordos 017000,China;Obstetrics and Gynecology Department of Ordos Central Hospital,Ordos 017000,China)

机构地区：[1]鄂尔多斯市中心医院药剂科,内蒙古鄂尔多斯017000 [2]鄂尔多斯市中心医院妇产科,内蒙古鄂尔多斯017000

出　　处：《中国药物应用与监测》2023年第6期448-451,共4页Chinese Journal of Drug Application and Monitoring

基　　金：鄂尔多斯市卫生健康委员会医学重点学科建设项目(鄂卫健发[2020]230号)。

摘　　要：目的:通过分析美国食品药品监督管理局不良事件报告系统(FDA Adverse Event Reporting System,FAERS)数据库,挖掘拉贝洛尔相关的药品不良事件(ADE),为临床用药监护提供参考。方法:收集FAERS数据库2004—2022年第一季度的ADE报告,采用OpenVigil 2.1数据平台,对所有使用拉贝洛尔患者的ADE进行预处理,进一步利用报告比值比(ROR)法和比例报告比值比(PRR)法对ADE进行分析,获得发生频次及信号强度前10位的ADE,并分析前10位ADE中患者的联合用药情况。结果:共上报的ADE有658个,其中136个属于药品不良反应(ADR)。658个ADE事件中,有588例次是因怀孕期间药物暴露所致(PRR=17.99,χ^(2)=7591.23;ROR=19.43,95%CI=17.69~1.34),其次是早产儿、肝损害、过度紧张、急性肾损伤、血压过低、肾衰竭等。信号强度分析结果显示,阴囊转位(PRR=2578.43,χ^(2)=2146.19;ROR=2579.69,95%CI=430.96~15441.72)是信号强度最高的ADE事件,其次是人畜共患细菌感染、胃肠梗阻、新生儿中性粒细胞减少、髓圆锥综合征、全身血管阻力增加、眼睛痣等。联合用药中,由高到低为硝苯地平、肼苯哒嗪、氨氯地平、阿司匹林、甲基多巴、倍他米松、阿司匹林、硫酸镁及左旋甲状腺素钠。结论:拉贝洛尔在应用过程中,应密切检测其不良反应情况,同时应关注其联合用药情况。Objective:To mine the labetalol-related adverse drug events(ADE)from the FDA Adverse Event Reporting System(FAERS)database to provide reference for clinical medication monitoring.Methods:The ADE reports in FAERS database from 2004 to the first quarter of 2022 were collected.The OpenVigil 2.1 data platform was used to preprocess the ADE of all patients using labetalol.The report odds ratio(ROR)method and the proportional report odds ratio(PRR)method were further used to analyze the ADE.The top 10 ADE in frequency and signal intensity were obtained and the combined medication in them was analyzed.Results:A total of 658 ADEs were reported and 136 of them belonged to adverse drug reactions(ADR).Among 658 ADEs,588 were caused by drug exposure during pregnancy(PRR=17.99,χ^(2)=7591.23;ROR=19.43,95%CI=17.69-1.34),and others by premature infants,liver damage,excessive tension,acute kidney injury,low blood pressure and renal failure,etc.The signal intensity analysis showed that scrotal transposition(PRR=2578.43,χ^(2)=2146.19;ROR=2579.69,95%CI=430.96-15441.72)was the highest signal intensity ADE event,which was followed by zoonotic bacterial infection,gastric intestinal obstruction,neonatal neutropenia,medullary cone syndrome,systemic vascular resistance increase and eye nevus,etc.In the patients with combined medication,the signal intensity from high to low was nifedipine,hydralazine,amlodipine,aspirin,methyldopa,betamethasone,aspirin,magnesium sulfate and levothyroxine sodium.Conclusion:During use of labetalol,its adverse reactions should be carefully detected,and combined medication should also be paid close attention to.

关 键 词：拉贝洛尔 FAERS数据库 药品不良事件 联合用药 信号挖掘 

分 类 号：R969.3[医药卫生—药理学]