碘对比剂在冠状动脉介入诊疗中的不良反应分析

Analysis of Adverse Drug Reactions Induced by Iodine Contrast Agent in Percutaneous Coronary Intervention

关键词:  碘对比剂  冠状动脉  药品不良反应

Key words:  iodine contrast agent  coronary artery  adverse drug reaction

摘要:

目的 探讨碘对比剂在冠状动脉介入诊疗中所致药品不良反应（ADR）的发生特点，为该类患者合理使用碘对比剂提供参考。方法 调取苏州大学附属第一医院2011年1月-2018年12月行冠状动脉介入诊疗的患者和同期上报国家ADR监测系统经冠状动脉给予碘对比剂致ADR的报告，分别从患者人口学特征、碘对比剂类型、ADR严重程度、发生时间、累及系统、临床表现和转归等方面进行统计分析。结果 期间使用碘克沙醇、碘海醇、碘佛醇和碘普罗胺的患者分别为4 631，7 074，13 058，66例，同期共上报71例ADR，发生率为2.9‰。71例ADR中迟发型有64例（90.1%），二次使用后发生ADR有7例（9.9%）；严重5例（7.0%），一般66例（93.0%），两者在性别（P=0.221）、年龄（P=1.000）、既往过敏史（P=1.000）、碘对比剂类型（P=0.427）和转归（P=1.000）中均无统计学差异，但严重ADR中速发型的比例显著高于一般ADR中速发型的比例（P<0.001）；ADR主要累及皮肤黏膜系统（63例，81.8%），其次是泌尿系统（6例，7.8%）和消化系统（5例，6.5%）；所有ADR经对症治疗后均转归良好。结论 碘对比剂在冠状动脉介入诊疗中的ADR以迟发型更为多见，主要累及皮肤黏膜系统，提示临床在冠状动脉给药时可能需要适当延长对ADR的观察时间，且即使患者初次用药后无ADR发生，在后续使用中同样应加强关注。

Abstract:

OBJECTIVE To investigate the characteristics of adverse drug reactions(ADR) induced by iodine contrast agent in coronary interventional therapy, and to provide reference for its rational use. METHODS Patients who underwent percutaneous coronary intervention from January 2011 to December 2018 and ADRs induced by iodine contrast agent in percutaneous coronary intervention during this period in the First Hospital Affiliated to Soochow University were enrolled for the study. The demographic characteristics of patients, types of iodine contrast agent, severity of ADR, time of occurrence, involved systems, clinical manifestations and outcomes were analyzed respectively. RESULTS The patients who used iodixanol, iohexol, iodophor and iopromide were 4 631, 7 074, 13 058 and 66, respectively. Seventy one cases of ADR were reported during this period and the incidence rate was 2.9‰. Of which, 64 cases(90.1%) were delayed ADR and 7 cases(9.9%) were after secondary use. Five cases(7.0%) with severe and 66 cases(93.0%) with general. There was no significant difference in gender(P=0.221), age(P=1.000), previous allergy history(P=0.460), type of iodine contrast agent(P=0.427) and outcome(P=1.000), but the proportion of acute ADRs in severe was significantly higher than that in general(P<0.001). Of these ADRs, 63 cases(81.8%) involved mucocutaneous system, followed by 6 cases with urinary system(7.8%) and 5 cases with digestive system(6.5%) involved urinary system and digestive system, respectively. All ADRs had a good outcome after symptomatic treatment. CONCLUSION The ADR induced by iodine contrast agent in coronary interventional therapy is mainly involved mucocutaneous system. As it is more common to have delayed reactions, the clinical may need to extend the observation time of ADR, and even if the patient does not have ADR after the initial use, the focus on ADR should also be strengthened in the subsequent use.