碘对比剂不良反应报告分析  

Analysis of Adverse Reactions of Iodine Contrast Agent

作　　者：徐元杰[1] 张晶[2] 王茹[3] 蔡伟伟 赵鹏芝[3] 郭代红[3] XU Yuanjie;ZHANG Jing;WANG Ru;CAI Weiwei;ZHAO Pengzhi;GUO Daihong(Department of Pharmacy,General Hospital of the PLA,Beijing 100853,China)

机构地区：[1]解放军总医院卫勤部,北京100853 [2]解放军总医院第一医学中心放射诊断科,北京100853 [3]解放军总医院药学部,北京100853 [4]蚌埠医学院药学院,安徽蚌埠233030

出　　处：《中国医学影像学杂志》2020年第3期232-235,共4页Chinese Journal of Medical Imaging

基　　金：基于大数据的军队药物警戒体系建设研究(17CXZ010)。

摘　　要：目的分析碘对比剂不良反应(ADR)报告,探讨碘对比剂ADR发生特点及规律,为降低临床用药风险提供参考。资料与方法回顾性分析解放军药品不良反应监测中心数据库中1260例碘对比剂ADR报告,内容包括患者基本信息、药品名称、给药途径、累及系统/器官、ADR临床表现、ADR诱导时间、严重程度级别、关联性评价及转归等。结果 1260例ADR报告中,男/女比为1.88∶1。第一怀疑药品前3位依次为碘克沙醇(533例,42.3%)、碘海醇(274例,21.75%)、碘佛醇(248例,19.68%)。ADR累及系统/器官最常见为皮肤及皮肤附件损害(661例次),其次为出血及凝血障碍(246例次),第3位为胃肠疾病(188例次)。常见ADR前3位依次为皮疹(497例)、瘙痒(215例)、潮红(190例)。1140例(90.48%)ADR发生于24 h内。结论碘对比剂引起ADR以急性、中轻度为主,但仍需警惕严重ADR。医护人员需重视碘对比剂使用过程中可能发生的安全问题,并掌握不良反应的预防和应急处理措施。Purpose To analyze the adverse drug reactions(ADR) reports of iodine contrast agents, to understand the characteristics and general regularities of ADR of iodine contrast agents, and to provide reference on reducing the risks of clinical drug treatment. Materials and Methods Retrospectively research reports of 1260 cases iodine contrast agents causing ADR in the database of the People’s Liberation Army ADR monitoring center were analyzed, including the patients’ basic information, suspicious drugs, administration route, involvement of systems/organs, ADR clinical manifestations, ADR induction time, severity levels, relevance assessments, outcomes and soon. Results Among the 1,260 ADR reports, the male/female ratio was 1.88∶1. The top three suspected drugs were Iodixanol(533 cases, 42.3%), Iohexol(274 cases, 21.75%), and Ioversol(248 cases, 19.68%). The most common ADR-affected system/organ was skin and skin accessory damage(661 cases), followed by bleeding and coagulopathy(246 cases), and the third place was gastrointestinal disease(188 cases). The top three common ADR were rash(497 cases), pruritus(215 cases), and flushing(190 cases). ADR occurred in 1,140 cases(90.48%) within 24 hours. Conclusion ADR caused by Iodine contrast is mainly acute, moderate and mild, but it is necessary to be alert to severe ADR. Medical personnel need to pay attention to the safety problems that may occur during the use of iodine contrast agents, and to master the prevention and emergency treatment of adverse reactions.

关 键 词：碘 造影剂 药物相关性副作用和不良反应 药物副反应报告系统 回顾性研究 

分 类 号：R595.3[医药卫生—内科学]