基于FAERS数据库对玛伐凯泰不良事件信号挖掘与分析  

Mining and analysis of adverse event signals for mavacamten based on FAERS

作　　者：谢沛锋 罗佳妮 谭胜蓝 谭亲友[1,3] XIE Peifeng;LUO Jiani;TAN Shenglan;TAN Qinyou(College of Pharmacy,Guilin Medical University,Guilin 541199,China;Department of Pharmacy,Second Xiangya Hospital of Central South University,Changsha 410011,China;Department of Clinical Pharmacy and Clinical Pharmacology,Affiliated Hospital of Guilin Medical College,Guilin 541001,China)

机构地区：[1]桂林医学院药学院,广西桂林541199 [2]中南大学湘雅二医院药学部,湖南长沙410011 [3]桂林医学院附属医院临床药学与临床药理学教研室,广西桂林541001

出　　处：《现代药物与临床》2024年第12期3221-3228,共8页Drugs & Clinic

基　　金：中南大学教育教学改革项目(2023jy104);中南大学研究生教育教学改革项目(2023JGB097);美国中华医学会基金(19-343)。

摘　　要：目的基于美国食品药品管理局不良事件报告系统(FAERS)挖掘与分析玛伐凯泰潜在的药品不良事件信号,为临床安全用药提供参考。方法利用线上药物警戒工具Open Vigil 2.1版,收集FAERS数据库中2022年4月1日—2024年9月30日的玛伐凯泰相关不良事件报告,利用比例失衡法中的报告比值比法(ROR)和比例报告比值法(PRR)进行数据挖掘。结果经数据清洗后,收集到玛伐凯泰不良事件报告1802份,共挖掘到43个有效不良事件信号,其中发生频次较高的不良事件信号与药品说明书中的基本一致。此外,还发现了心房颤动、鼻咽炎、体质量增加、尿路感染、高血压等30个不良事件信号未被药品说明书提及。结论在临床应用玛伐凯泰时,除了需重点关注药品说明书中已明确的不良事件外,还应警惕心房颤动、鼻咽炎、尿路感染、体质量增加、高血压等药品说明书未提及的不良事件。在用药前及用药过程中,应监测患者的左心室射血分数(LVEF),避免LVEF降低、心力衰竭等严重不良反应的发生,以确保患者的用药安全。Objective To mine and analyze potential adverse drug event signals associated with mavacamten based on the FAERS,providing reference for clinical medication safety.Methods Using the online pharmacovigilance tool Open Vigil version 2.1,adverse drug event reports related to mavacamten in the FAERS database from April 1,2022,to September 30,2024,were collected.Data mining was performed utilizing the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods.Results After data cleaning,a total of 1802 adverse drug event reports related to mavacamten were collected,identifying 43 valid adverse drug event signals.The most frequently occurring adverse drug event signals were consistent with those specified in the product labeling.Additionally,30 adverse drug event signals,including atrial fibrillation,nasopharyngitis,weight gain,urinary tract infection,and hypertension,were identified that were not mentioned in the product labeling.Conclusion When clinically applying mavacamten,it is crucial to not only monitor the adverse drug events explicitly listed in the product labeling but also to remain vigilant for unmentioned adverse drug events such as atrial fibrillation,nasopharyngitis,urinary tract infection,weight gain,and hypertension.Prior to and during treatment,patient LVEF should be monitored to prevent severe adverse reactions such as LVEF reduction and heart failure,ensuring medication safety for patients.

关 键 词：玛伐凯泰 选择性心肌肌球蛋白抑制剂 药物不良事件 信号挖掘 FAERS数据库 心房颤动 鼻咽炎 尿路感染 高血压 

分 类 号：R972[医药卫生—药品]