我院5年间冠脉介入术中碘造影剂过敏反应监测报告分析  

A5-year AnalysisonIodineContrastInducedAnaphylacticReactionOccurredDuringPercutaneousCoronary Intervention

作　　者：庄伟[1,2] 刘玉清[1] 李一石[1] 张而立[1] 宋光远[1] 赵杰[1] 吴永健[1] 

机构地区：[1]中国医学科学院阜外心血管病医院,北京100037 [2]福建医科大学附属第一医院心内科,福建福州350005

出　　处：《中国药物警戒》2013年第12期734-736,共3页Chinese Journal of Pharmacovigilance

基　　金："重大新药创制"科技重大专项-<心血管创新药物临床研究技术平台建设>(2012ZX09303008-001)

摘　　要：目的研究和分析冠脉介入术中碘造影剂发生过敏反应的特点，为降低碘造影剂在冠脉介入手术中的使用风险提供参考。方法选用回顾性研究方法，对阜外心血管病医院2007～2012年住院冠脉介入手术（包括冠脉造影）中发生碘造影剂过敏反应病例资料，分别按照患者性别、年龄、临床表现以及引起过敏反应的碘造影剂种类等进行描述性统计分析。结果在79102监测到48例非离子型碘造影剂过敏反应，发生率0．61％o（48，78600）。其中男性患者为44例、女性患者为4例，男女比例11：1；涉及药品包括碘海醇、碘佛醇、碘帕醇、碘克沙醇、碘普罗胺等常用的非离子型碘造影剂，以碘普罗胺和碘克沙醇为多。过敏反应临床表现多样，以皮疹等皮肤黏膜表现最为常见，过敏性休克最为严重，其中死亡2例。结论在冠脉介入术中应用非离子型碘造影剂安全性良好，但仍需重视对其药品不良反应的监测、报告与分析；早期识别、早期干预，以提高用药安全与冠脉介入手术安全。Objective To analyze the characteristics of iodine contrast induced anaphylactic reaction occurred during percutaneous coronary intervention（PCI）, so as to provide a reference to reduce the risk of its use. Methods By searching the clinical database of Beijing Fuwai Cardiovascular Hospital, we retrospectively investigated the incidence of iodine contrast induced anaphylactic reaction during PCI, including coronary angiography, in recent 5 years. We described the relationships between the use of the agent and gender, age, clinical manifestation, and the type of the agent, respectively. Results In all of the 79 102 patients who received PCI, 48 patients（0.061%） ended up with anaphylactic reaction. Among them, 44（0.056%） patients were males and 4（0.02%） patients were females. The ratio between male and female was 11：1. Some commonly used non-ion iodinated agents including iohexol, ioversol, iopamidol, iodixanol and iopromide were involved, iopromide and iodixanol induced most of the anaphylactic reaction. The clinical manifestation of the anaphylactic reaction varied broadly, in which rash was the most commonly observed and shock was the severest drug adverse reaction. Two patients eventually died of severe anaphylactic reaction. Contusion In general, non-ion iodinated contrast is safe to use in PCI. However, it is still necessary to carefixUy monitor the occur- rence of its anaphylactic reaction. Early recognition and intervention of its manifestation is very critical to improve the safety of both drug use and PCI.

关 键 词：冠脉介入手术 碘造影剂 药品不良反应 监测 分析 

分 类 号：R981.1[医药卫生—药品] R994.11[医药卫生—药学]