Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Pharmacovigilance Center, Asan Medical Center, Seoul, Korea.
Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Department of Applied Statistics, Chung-Ang Graduate University, Seoul, Korea.
J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2205-2211. doi: 10.1016/j.jaip.2019.02.035. Epub 2019 Mar 12.
The various adverse drug reactions (ADRs) arise from different types of iodinated contrast media (ICM).
Thus, we investigated the occurrence rate and types of ADRs according to the total usage cases of the 7 most common ICM.
We retrospectively reviewed 74,242 causal ADRs caused by ICM from the Korea Adverse Event Reporting System database between January 2014 and December 2016. The 11,712,796 total usage cases that represent all administrations of ICM reported from individual medical institutions were received from the Health Insurance Review and Assessment Service. A proportionality test was used to examine the differences in the frequency ratio of causal ADRs to total usage cases.
Immediate hypersensitivity (44,467 cases, 88.56%) occurred more frequently than delayed hypersensitivity (5,725 cases, 11.4%; P < .001). The overall occurrence rate of causal ADRs and serious ADRs considering total usage cases was 0.37% and 0.02%, respectively (P < .001). The ICM most commonly resulting in ADRs were iomeprol (0.7%) and iopromide (0.59%). The serious ADRs were most common for iomeprol (0.05%). When ADRs were classified according to the system organ class, "skin and appendages disorders" (47,065 cases, 63.4%) occurred most common. Iodixanol resulted in the highest frequency of "urinary system disorders."
By comparison of the ADRs considering total usage cases, the incidence and classification of ADRs were different for each contrast medium. A prospective study is needed because the differences in these 7 major contrast media may assist in the selection of ICM tailored for each patient.
各种药物不良反应（ADR）是由不同类型的碘造影剂（ICM）引起的。
因此，我们根据最常见的 7 种 ICM 的总使用情况，调查了 ADR 的发生率和类型。
我们回顾性分析了 2014 年 1 月至 2016 年 12 月期间韩国不良事件报告系统数据库中由 ICM 引起的 74242 例因果 ADR。从健康保险审查和评估服务处收到了来自各医疗机构报告的 11712796 总使用案例，这些案例代表了所有 ICM 的给药情况。采用比例性检验来检验因果 ADR 与总使用案例的频率比差异。
即刻超敏反应（44467 例，88.56%）比迟发性超敏反应（5725 例，11.4%；P<0.001）更常见。考虑到总使用案例，因果 ADR 和严重 ADR 的总发生率分别为 0.37%和 0.02%（P<0.001）。导致 ADR 最常见的 ICM 是碘普罗胺（0.7%）和碘海醇（0.59%）。严重 ADR 最常见于碘普罗胺（0.05%）。当根据系统器官分类对 ADR 进行分类时，“皮肤和附属器疾病”（47065 例，63.4%）最常见。碘克沙醇导致“泌尿系统疾病”的发生率最高。
通过比较考虑总使用案例的 ADR，每种造影剂的 ADR 发生率和分类都不同。由于这 7 种主要造影剂的差异可能有助于为每位患者选择量身定制的 ICM，因此需要进行前瞻性研究。
