基于FAERS的齐留通的药物警戒评价  

Pharmacovigilance Evaluation of Zileuton Based on FAERS

作　　者：兰冬梅 郭琳 倪昊天 LAN Dong-mei;GUO Lin;NI Hao-tian(The Affiliated Hospital of Xuzhou Medical University,Xuzhou Jiangsu 221004,China)

机构地区：[1]徐州医科大学附属医院,江苏徐州221004

出　　处：《抗感染药学》2023年第8期843-847,共5页Anti-infection Pharmacy

基　　金：徐州市重点研发计划项目(编号:KC22256)。

摘　　要：目的:基于美国FDA不良事件报告系统(FDA adverse event reporting system,FAERS)分析和评价齐留通的临床用药风险,为临床齐留通的用药安全提供参考。方法:利用OpenVigil工具在FAERS的Open-FDA数据库中检索2004年1月1日—2022年9月30日上报的有关齐留通的不良事件,采用报告比值比法和贝叶斯可信传播神经网络法分析齐留通的不良事件发生特点及其风险。结果:在Open-FDA数据库中共计挖掘出有关齐留通的不良事件报告215例,其中患者性别多为女性(158例,占73.49%),致患者住院或严重住院、残疾等严重不良事件共58例(占26.98%);215例报告共涉及26个信号,共映射在8个SOC中,其中主要的SOC分别为“呼吸、胸腔和纵膈疾病”(87例,占40.66%)“、皮肤及皮下组织疾病”(43例,占20.00%)和“实验室指标异常”(46例,占21.40%,均与肝功能损害有关);信号强度检测显示,强警戒信号有13个(其中与肝功能损害有关的有5个,与呼吸功能异常相关的有4个),中度警戒信号有11个。结论:基于FAERS的数据提示,齐留通的用药风险主要表现为肝功能损害和呼吸系统异常,临床在进行相关治疗时应加强监护,确保患者的用药安全。Objective:To analyze and evaluate the clinical medication risks of zileuton based on the US FDA adverse event reporting system(FAERS),and provide reference for the clinical medication safety of zileuton.Methods:With the OpenVigil tool,adverse events related to zileuton reported from January 1,2004 to September 30,2022 were retrieved from the Open-FDA database of FAERS,and the characteristics and risks of adverse events related to zileuton were analyzed using the reporting odds ratio method and Beyesian confidence propagation neural network method.Results:A total of 215 adverse event reports related to zileuton were discovered in the Open-FDA database,of which 158 were females(73.49%),including a total of 58 cases(26.98%)of serious adverse events such as hospitalization or severe hospitalization and disability of patients;215 reports involved a total of 26 signals,mapped to 8 SOC,with the main SOC of"respiratory,thoracic,and mediastinal diseases"(87 cases,40.66%),"skin and subcutaneous tissue diseases"(43 cases,20.00%),and"abnormal laboratory indicators"(46 cases,21.40%,all related to liver function damage);the signal intensity detection showed that there were 13 strong warning signals(including 5 related to liver function damage and 4 related to respiratory function abnormalities),and 11 moderate warning signals.Conclusion:Based on FAERS data,the main risks of zileuton are liver function damage and respiratory system abnormalities.Monitoring should be strengthened during clinical treatment to ensure the medication safety of patients.

关 键 词：齐留通 美国FDA不良事件报告系统 药物不良反应 

分 类 号：R181.35[医药卫生—流行病学] R969.3[医药卫生—公共卫生与预防医学]