Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, Fujian, China.
Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, Fujian, China.
J Allergy Clin Immunol Pract. 2023 May;11(5):1494-1502.e6. doi: 10.1016/j.jaip.2023.01.027. Epub 2023 Feb 1.
A comparative hypersensitivity risk profile of frequently used iodinated contrast media (ICM) may be required for their safer use.
To explore the association between hypersensitivity reactions (HSRs) and specific ICM and characterize the spectrum of ICM-related HSRs.
We performed a disproportionality analysis and proportionality test to assess the safety profile of ICM-related HSRs and compare the frequency ratio of specific HSRs in diverse age, sex, and country subgroups. We used reports downloaded from the US Food and Drug Administration Adverse Event Reporting System and data on the national use of individual ICM for this analysis.
A total of 11,343,365 adverse event reports were collected from the first quarter of 2013 to the first quarter of 2021, among which 5,432 cases were identified as ICM-induced HSRs. All of the studied ICMs were associated with overreporting frequencies of HSRs, in which iomeprol showed the highest reporting odds ratio (ROR) of 24.75 (95% CI, 19.61-31.24). Iopromide (ROR = 22.29; 95% CI, 20.18-24.62) and ioversol (ROR = 20.85; 95% CI, 18.54-23.44) were more likely to cause angioedema than other ICMs, particularly in the group aged 45 to 64 years. Iomeprol was associated with the largest disproportionality for severe cutaneous adverse reactions (ROR = 127.90; 95% CI, 103.32-159.88), whereas iodixanol exhibited maximal incidence when total use cases were considered. Regarding anaphylactic shock, iopamidol presented the highest disproportionality (ROR = 31.11; 95% CI, 27.15-35.65), especially in males or seniors aged greater than 65 years, whereas iopromide resulted in the maximum frequency in China and the United States.
Different ICMs exhibited diverse profiles regarding HSRs, which could be further affected by age, sex, or geographic area. Prospective studies are required for patient safety.
为了更安全地使用经常使用的碘造影剂（ICM），可能需要比较其过敏风险概况。
探索过敏反应（HSR）与特定 ICM 之间的关联，并描述 ICM 相关 HSR 的特征。
我们进行了不成比例性分析和比例性检验，以评估 ICM 相关 HSR 的安全性概况，并比较不同年龄、性别和国家亚组中特定 HSR 的频率比。我们使用从美国食品和药物管理局不良事件报告系统下载的报告和有关个别 ICM 全国使用的数据进行了此项分析。
从 2013 年第一季度到 2021 年第一季度共收集了 11343365 份不良事件报告，其中 5432 例被确定为 ICM 引起的 HSR。所有研究的 ICM 均与 HSR 报告频率过高有关，其中碘普罗胺的报告优势比（ROR）最高，为 24.75（95%CI，19.61-31.24）。碘普罗胺（ROR=22.29；95%CI，20.18-24.62）和碘佛醇（ROR=20.85；95%CI，18.54-23.44）比其他 ICM 更易引起血管性水肿，尤其是 45 至 64 岁年龄组。碘普罗胺与严重皮肤不良反应的最大不成比例性相关（ROR=127.90；95%CI，103.32-159.88），而当考虑总使用病例时，碘海醇的发生率最高。关于过敏性休克，碘帕醇的不成比例性最高（ROR=31.11；95%CI，27.15-35.65），尤其是男性或 65 岁以上的老年人，而碘普罗胺在中国和美国的频率最高。
不同的 ICM 在 HSR 方面表现出不同的特征，这可能会进一步受到年龄、性别或地理区域的影响。需要进行前瞻性研究以确保患者安全。
