基于FAERS数据库的凡德他尼不良事件信号挖掘与分析  

Mining and Analysis of Adverse Event Signals of Vandetanib Based on FAERS Database

作　　者：周莹 李娜 马国伟 苏宁 刘疆 殷瑞 陈洁 ZHOU Ying;LI Na;MA Guowei;SU Ning;LIU Jiang;YIN Rui;CHEN Jie(School of Pharmacy,Dali University,Dali Yunnan 671000,China;Kunming Third People's Hospital,Yunnan Infectious Disease Clinical Medical Center,Kunming Yunnan 650041,China)

机构地区：[1]大理大学药学院,云南大理671000 [2]昆明市第三人民医院,云南省传染性疾病临床医学中心,云南昆明650041

出　　处：《药品评价》2024年第4期401-406,共6页Drug Evaluation

摘　　要：目的通过对凡德他尼药品不良反应事件(AE)的信号挖掘分析,为临床合理用药提供参考。方法获取美国FAERS数据库中2011年第二季度—2023年第一季度共48个季度的凡德他尼相关AE报告,采用比例失衡法的ROR法和MHRA法,根据《国际医学用药词典》(26.0版)ADR术语集中的SOC和PT对AE进行描述和分类。结果共检索到凡德他尼为首要怀疑药物的AE报告1721份,经ROR法、MHRA法挖掘出有效AE信号187个,涉及20个系统器官分类,其中有47个信号未在凡德他尼药品说明书中提及,包括肿瘤溶解综合征以及皮肤变色、皮肤剥脱和色素沉着障碍等皮肤及皮下组织类疾病。凡德他尼AE发生的中位时间为40天,且大多数AE发生在服用凡德他尼的前一个月内。结论所挖掘出的常见AE信号与药品说明书一致;临床使用中应特别关注肿瘤溶解综合征、皮肤变色、皮肤剥脱和色素沉着障碍等其药品说明书中未提及的AE,密切监测患者皮肤、实验室指标的异常,并及时予以干预,以保障患者用药的安全性。Objective To provide reference for clinical rational drug use through signal mining analysis of adverse event(AEs)of Vandetanib drugs.Methods Obtain 48 quarterly reports on AEs related to Vandetanib from the US FAERS database from the second quarter of 2011 to the first quarter of 2023.Use the ROR method and the MHRA method to describe and classify AEs based on the SOC and PT in the ADR terminology set of the International Medical Dictionary(26.0 edition).Results A total of 1721 AEs reports were retrieved with Vandetanib as the primary suspected drug.Through ROR and MHRA methods,187 effective AEs signals were identified,involving 20 systemic organ classifications.Among them,47 signals were not mentioned in the drug instructions of Vandetanib,including tumor lysis syndrome,skin discoloration,skin exfoliation,and pigmentation disorders in skin and subcutaneous tissue diseases.The median time for the occurrence of AEs with Vandetanib was 40 days,and most AEs occured within the month prior to taking Vandetanib.Conclusion The common AE signals mined are consistent with the drug instructions;in clinical use,special attention should be paid to adverse events such as tumor lysis syndrome,skin discoloration,skin exfoliation,and pigmentation disorders that are not mentioned in the drug instructions.Patients should be closely monitored for abnormal skin and laboratory indicators,and timely intervention should be given to ensure the safety of medication for patients.

关 键 词：凡德他尼 药品不良反应 FAERS数据库 信号挖掘 

分 类 号：R969[医药卫生—药理学]