【摘要】 目的 基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库进行分析，挖掘碘造影剂碘佛醇的不良反应(ADR)信号，为临床安全用药提供参考。方法 提取2004年第一季度至2024年第二季度FAERS数据库中所有上报的碘佛醇相关不良反应报告，采用频率方法和贝叶斯法，用于碘佛醇ADR信号挖掘。结果 从FAERS数据库中，共检索到碘佛醇的ADR报告3518份。涉及27个系统/器官分类(SOC)，前5位分别为呼吸系统、胸及纵隔疾病、皮肤及皮下组织类疾病、全身性疾病及给药部位各种反应、胃肠系统疾病和各类神经系统疾病。综合考虑频数法和贝叶斯法，获得154个ADR信号。与碘佛醇相关的ADR，报告频数较多的是荨麻疹、呼吸困难、瘙痒、皮疹、咽喉刺激和喷嚏等ADR。结论 碘佛醇实际应用存在部分说明书未收录的不良反应(如皮疹、咽喉刺激)，在临床实际应用中需全面关注相关不良反应，尽早采取措施，提高临床用药的安全性。更多还原

【Abstract】 Objective To mine signals of adverse drug reaction (ADR) associated with iodine-based contrast agent ioversol based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database,and to provide reference for safe drug use.Methods All the reports of iofortol related ADRs reported in FAERS database from Q1 2004 to Q2 2024 were collected.Frequency method and Bayesian method were used to mine the ADR signals of ioversol.Results Totally 3518 ADR reports of ioversol were retrieved from FAERS database,involving 27 system organ class (SOCs).The top 5 were respiratory system,chest and mediastinum diseases,skin and subcutaneous tissue diseases,systemic diseases and reactions at the drug administration site,gastrointestinal system diseases,and various neurological diseases.By combining frequency method and Bayesian method,154 ADR signals were obtained.Urticaria,dyspnea,pruritus,rash,throat irritation and sneezing were the most frequently reported ADRs induced by ioversol.Conclusion Some ADRs (e.g.rash,throat irritation) are not included in the manual of ioversol.We should pay attention to relevant ADRs to promote safe drug use.更多还原