目的:本研究旨在评估药物警戒(PV)和非离子型碘造影剂(ICM)引起的超敏反应的严重程度,并报告给美国食品和药物管理局不良事件报告系统(FAERS)的放射学诊断。
方法:我们回顾性回顾了2015年1月至2023年1月提交给FAERS数据库的ICM引起的超敏反应报告,并进行了不成比例的分析。七个最常见的非离子ICM,包括碘海醇,iopamidol,ioversol,碘普罗胺,iomeprol,iobitridol,和碘克沙醇,主要进行了分析。我们的主要终点是非离子型ICM诱导的总超敏反应事件的PV。采用STATA17.0MP进行统计分析。
结果:总计,从FAERS数据库中检索了35357份放射学诊断中的不良反应事件报告。其中,6181份报告涉及超敏反应事件(平均年龄:57.1±17.8岁)。检测到碘海醇的超敏反应相关PV信号,ioversol,碘普罗胺,iomeprol,iobitridol,和碘克沙醇,但不是iopamidol.已发现iomeprol诱导的超敏反应的比例和ioversol诱导的严重超敏反应的可能性显着增加。
结论:非离子型ICM中超敏反应事件的概率和严重程度不同。碘海醇,ioversol,碘普罗胺,iomeprol,iobitridol,与碘帕醇相比,碘克沙醇的风险更高。此外,iomeprol引起的超敏反应的构成比显著增加,ioversol诱导的相关概率显著增加。
OBJECTIVE: This study aimed to evaluate the Pharmacovigilance (PV) and severity of hypersensitivity reactions induced by non-ionic Iodinated Contrast Media (ICM) in the radiology diagnosis reported to the United States Food and Drug Administration Adverse Event Reporting System (FAERS).
METHODS: We retrospectively reviewed the reports of ICM-induced hypersensitivity reactions submitted to the FAERS database between January 2015 and January 2023 and conducted a disproportionality analysis. The seven most common non-ionic ICM, including iohexol,
iopamidol, ioversol, iopromide, iomeprol, iobitridol, and iodixanol, were chiefly analyzed. Our primary endpoint was the PV of non-ionic ICM-induced total hypersensitivity events. STATA 17.0 MP was used for statistical analysis.
RESULTS: In total, 35357 reports of adverse reaction events in radiology diagnosis were retrieved from the FAERS database. Among them, 6181 reports were on hypersensitivity reaction events (mean age: 57.1 ± 17.8 years). The hypersensitivity reaction-related PV signal was detected for iohexol, ioversol, iopromide, iomeprol, iobitridol, and iodixanol, but not for
iopamidol. The proportion of iomeprol-induced hypersensitivity reactions and the probability of ioversol-induced severe hypersensitivity reactions have been found to be significantly increased.
CONCLUSIONS: The probability and severity of hypersensitivity reaction events in non-ionic ICM are different. Iohexol, ioversol, iopromide, iomeprol, iobitridol, and iodixanol have higher risks compared to
iopamidol. In addition, the constituent ratio of hypersensitivity reactions induced by iomeprol is significantly increased, and the associated probability induced by ioversol is significantly increased.