5种三唑类抗真菌药物的药物不良反应分析

Analysis of adverse drug reactions of five triazole antifungal drugs

目的 分析氟康唑、伊曲康唑、伏立康唑、泊沙康唑和艾沙康唑的药物不良反应(adverse drug reaction,ADR)特征。方法 在美国食品药品管理局公共数据开放项目(U.S.food and drug administration open public data project,openFDA)检索2004-01-01—2021-03-31提交的关于氟康唑、伊曲康唑、伏立康唑、泊沙康唑和艾沙康唑的ADR报告,对年龄、性别、适应症、给药途径、常见ADR、严重药物不良反应、药物剂量调整及患者转归情况进行统计分析。结果 在openFDA数据库中有关氟康唑、伊曲康唑、伏立康唑、泊沙康唑和艾沙康唑的ADR报告数目分别为35 654,6 218,12 164,3 837和800例。发生ADR人群的年龄主要集中于19~64岁,主要是预防和治疗侵袭性真菌感染,此5种三唑类抗真菌药物给药途径通常为口服及静脉。发生的ADR涉及多个系统,主要表现为发热、恶心、腹泻及QT间期的变化等症状。结论 除了常见的ADR外,还发现氟康唑、伊曲康唑、伏立康唑、泊沙康唑和艾沙康唑说明书中未提到的ADR,为临床中合理使用三唑类药物提供参考。

Objective To analyze the adverse drug reactions(ADR) characteristics of fluconazole,itraconazole,voriconazole,posaconazole and esaconazole.Methods The ADR reports on fluconazole,itraconazole,voriconazole,posaconazole and isaconazole submitted from January 1,2004 to March 31,2021 were retrieved in the public data open project of the U.S.food and drug administration(openFDA),and the age,gender,indication,route of administration,common ADR,serious adverse drug reactions,drug dose adjustment and patient outcome were statistically analyzed.Results In the openFDA database,the number of ADR reports related to fluconazole,itraconazole,voriconazole,posaconazole and esaconazole were 35 654,6 218,12 164,3 837 and 800,respectively.The age of ADR patients was mainly 19-64 years old,mainly for the prevention and treatment of invasive fungal infection.The five triazole antifungal drugs were usually administered orally and intravenously.ADR involves multiple systems and is mainly manifested as fever,nausea,diarrhea and QT interval changes.Conclusion In addition to common ADRs,other ADRs that were not mentioned in the instructions of fluconazole,itraconazole,voriconazole,posaconazole and esaconazole were also found,providing reference for rational use of triazole drugs in clinical practice.