碘克沙醇与碘海醇药品不良反应发生特点的对比分析

摘要/Abstract

摘要： 目的分析碘克沙醇和碘海醇致药品不良反应（ADR）的特点，为临床安全用药提供参考。方法筛选2013年1月至2017年4月间杭州市药品与医疗器械不良反应监测中心收到的碘克沙醇和碘海醇药品不良反应报告，分成碘克沙醇组和碘海醇组，对两组患者的性别及年龄、ADR主要表现、严重ADR构成比、迟发型ADR构成比、ADR潜伏时间等进行比较分析，采用统计图、统计表、χ2检验、t检验、生存分析和Breslow检验进行统计分析。结果共收集到碘克沙醇和碘海醇药品不良反应报告228份，其中碘克沙醇引起的药品不良反应报告73份，碘海醇引起的药品不良反应报告155份。碘克沙醇组平均年龄大于碘海醇组，两组间有统计学差异（P＜0.05）。碘克沙醇组严重ADR构成比（6.85%）低于碘海醇组（8.39%），两组间没有统计学差异（P =0.69）。碘克沙醇组迟发型ADR构成比（69.86%）明显高于碘海醇组（7.10%），两组间有统计学意义（P＜0.01）。碘克沙醇组发生ADR的平均潜伏时间比碘海醇组长，两组间有统计学意义（P＜0.01）。结论碘克沙醇与碘海醇引发的ADR表现有所不同，与碘海醇组相比，碘克沙醇组迟发型ADR构成比较高，ADR潜伏时间较长，可考虑适当延长临床使用后的医学观察时间。

关键词: 碘克沙醇, 碘海醇, 药品不良反应

Abstract: Objective To investigate the characteristics of adverse drug reactions (ADRs) caused by iodixanol and iohexol in order to provide reference for safe drug use in clinical practice. Methods Reports of ADR caused by iodixanol and iohexol were selected from database of Hangzhou Drug and Medical Devices Adverse Reaction Monitoring Center from January 2013 to April 2017 and divided into two groups. Patients' information, major manifestations, proportion of serious ADR, proportion of delayed ADR and latent time of ADR were compared. Statistical methods such as statistical tables, statistical graphs, chi-square test, t-test, survival analysis and Breslow test were used to deal with the data. Results A total of 228 reports were entered, including 73 cases caused by iodixanol and 155 cases caused by iohexol. Mean age of iodixanol group was older than iohexol group (P<0.05). There was no statistically significant difference (P=0.69) in proportion of serious ADR between the two groups: 6.85% for iodixanol vs. 8.39% for iohexol. Proportion of delayed ADR of iodixanol group (69.86%) was higher than iohexol group (7.10%) (P<0.01). Average latent time of iodixanol group was longer than iohexol group (P<0.01). Conclusion Iodixanol and iohexol have some different clinical manifestations in ADR, iodixanol had higher proportion of delayed ADR and longer latent time, so maybe it's necessary to prolong medical observation time properly after administration of iodixanol.

Key words: iodixanol, iohexol, adverse drug reaction

中图分类号:

R994.11

徐志祥. 碘克沙醇与碘海醇药品不良反应发生特点的对比分析[J]. 中国药物警戒, 2018, 15(2): 125-128.

XU Zhi-xiang. Comparative Analysis of Adverse Drug Reactions Caused by Iodixanol and Iohexol[J]. Chinese Journal of Pharmacovigilance, 2018, 15(2): 125-128.

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