基于OpenFDA对替西帕肽不良反应风险信号的挖掘与分析

Mining and analysis of adverse reaction risk signals of tirzepatide based on OpenFDA

目的基于美国食品药品管理局公共数据开放项目(OpenFDA)对替西帕肽相关不良反应及安全警戒信号进行挖掘与分析,为临床安全用药提供参考依据。方法以“Tirzepatide”为关键词检索并提取不良事件报告系统(FAERS)中2022年7月1日~2023年12月31日之间相关的药品不良事件报告,采用报告比值比(ROR)法对原始数据进行挖掘分析。结果在此期间,检索出不良事件报告共2129332份,其中与替西帕肽相关的报告为25659份。替西帕肽相关的药品不良事件(ADE)报告数量随上市时间逐渐递增,报告主要来自美国,报告者主要集中在消费者和非医务人员。患者67.19%为女性,18.57%为男性,14.24%性别不明,年龄分布在18~74岁之间。共检测到有临床参考意义的阳性信号50个,涉及11个系统/器官。结论胃肠道反应是用药后常见的不良事件,胰腺炎、糖尿病视网膜病变、胆囊/胆道疾病及甲状腺疾病是临床上应关注的不良反应。除去说明书记载的不良反应外,血糖升高、糖化血红蛋白增加和糖尿病酮症酸中毒等同样需要临床重视。

Objective Based on the U.S.Food and Drug Administration Open database(OpenFDA),the adverse reactions related to tirzepatide and its safety warning signals were mined and analyzed,which provided a reference for clinical safe medication.Methods The related adverse drug event(ADE)reports from July1,2022 to December 31,2023 were retrieved in the Adverse event Reporting System(FAERS)with the keyword"Tirzepatide".The raw data were mined and analyzed by the reporting odds ratio(ROR)method.Results During this period,a total of 2129332 adverse event reports were retrieved,of which 25659 were related to tirzepatide.The number of tirzepatide-related ADE reports was increasing gradually,and the ADE reports were mainly from the United States,mainly reported by consumers and non-health professional.67.19%of the patients were female,18.57%were male,and 14.24%were of unknown gender.The age distribution was between 18 and 74 years old.A total of 50 positive signals with clinical reference significance were detected,involving 10 systems/organs.Conclusion Gastrointestinal reactions were the most common adverse events.Pancreatitis,diabetic retinopathy,gallbladder/biliary tract diseases and thyroid diseases were the adverse events that should be paid more attention in clinical practice.In addition to the adverse reactions recorded in the instructions,the increase of blood glucose,glycosylated hemoglobin,diabetic ketoacidosis and mental illness also need clinical attention.