碘造影剂相关甲状腺功能障碍:一项真实世界信号挖掘研究  

Iodine contrast medium-associated thyroid dysfunction:a real-world signal mining study

作　　者：谢昊[1] 陈力[2] 何绪成 舒亚民 赵彬[1] XIE Hao;CHEN Li;HE Xucheng;SHU Yamin;ZHAO Bin(Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College,Beijing 100730,China;Department of Pharmacy/Evidence-based Pharmacy Center,West China Second University Hospital,Sichuan University,Sichuan Chengdu 610041,China;Department of Pharmacy,Pengzhou Second People’s Hospital,Sichuan Chengdu 611934,China;Department of Pharmacy,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Hubei Wuhan 430030,China)

机构地区：[1]中国医学科学院北京协和医学院北京协和医院药剂科,北京100730 [2]四川大学华西第二医院药学部/循证药学中心,四川成都610041 [3]彭州市第二人民医院药剂科,四川成都611934 [4]华中科技大学同济医学院附属同济医院药学部,湖北武汉430030

出　　处：《中国医院药学杂志》2024年第1期67-73,共7页Chinese Journal of Hospital Pharmacy

基　　金：北京协和医院中央高水平医院临床科研专项(编号:2022-PUMCH-B-058);中国药学会医院药学专委会人才专项资助项目(编号:CPA-Z05-ZC-2022-003)。

摘　　要：目的:对全球已上市碘造影剂的甲状腺功能障碍不良事件信号进行全面挖掘,为临床安全使用提供参考。方法:获取美国食品药品监督管理局不良事件报告系统数据库中的报告,使用比例失衡法对碘造影剂的甲状腺功能障碍信号进行检测,并分析人口学信息、发生时间、患者结局。结果:碘海醇、碘帕醇、碘普胺、碘佛醇、碘克沙醇、泛影葡胺等6种碘造影剂有相关报告,碘海醇、碘帕醇、碘普胺未发现甲状腺功能减退信号,碘克沙醇信号强度最高。甲状腺功能减退主要为婴儿,女性居多,甲状腺功能亢进主要为成人,男性居多。发生时间集中在前30 d,严重结局比例甲状腺功能亢进显著高于减退(P<0.01)。结论:不同碘造影剂的甲状腺功能障碍风险可能不同。碘造影剂相关甲状腺功能减退与甲状腺功能亢进的好发年龄与性别不同。两者的发生时间通常在前30 d内,对于高危人群建议在这段时间进行甲状腺监测。甲状腺功能亢进可能导致更加严重的结局。OBJECTIVE To comprehensively mine the adverse event(thyroid dysfunction)signals of global marketed iodine contrast media,so as to provide reference for safe clinical use.METHODS The reports in the U.S.FDA Adverse Event Reporting System(FAERS)database were obtained.Disproportionality methods were used to detect the signals of thyroid dys⁃function caused by iodine contrast media,and demographic information,time to onset and patient outcome were analyzed.RESULTS Six iodine contrast media including iohexol,iopamidol,iopromide,ioversol,iodixanol and meglumine diatrizoate have been reported.Iohexol,iopamidol and iopromide had no hypothyroidism signal,and iodixanol had the highest signal inten⁃sity.Hypothyroidism mainly occurred in infants and females,while hyperthyroidism mainly occurred in adults and males.The time to onset was concentrated in the first 30 days.The proportion of serious outcomes was significantly higher in hyperthyroidism than that in hypothyroidism(P<0.01).CONCLUSION Different iodine contrast media may have different risks of thyroid dys⁃function.The incidence of iodine contrast medium-associated hypothyroidism and hyperthyroidism differs according to age and gen⁃der,while the occurrence of them is usually within the first 30 days,and thyroid surveillance is recommended during this time for high-risk individuals.Hyperthyroidism may lead to more severe outcomes.

关 键 词：FAERS 碘造影剂 甲状腺功能减退 甲状腺功能亢进 

分 类 号：R981.1[医药卫生—药品]