中国药物警戒 ›› 2026, Vol. 23 ›› Issue (9): 1040-1044.
DOI: 10.19803/j.1672-8629.20260123

• 安全与合理用药 • 上一篇    下一篇

1358例碘克沙醇注射液不良反应报告分析

赵志伟1, 柯文缘2, 杨雪1, 陈晓博1, 夏旭东1,*   

  1. 1河南省药品评价中心,河南 郑州 450008;
    2河南大学药学院,河南 开封 475000
  • 收稿日期:2026-02-10 出版日期:2026-09-15 发布日期:2026-09-15
  • 通讯作者: *夏旭东,男,硕士,正高级工程师•硕导,药品不良反应监测。E-mail: henanadr@126.com
  • 作者简介:赵志伟,男,硕士,高级工程师,药品不良反应监测。
  • 基金资助:
    河南省2025年科技发展计划（252102310460）; 河南省市场监督管理局2025年科技计划项目（HNSCJK202584）

1358 case reports of adverse drug reactions induced by iodixanol injection

Zhao Zhiwei1, Ke Wenyuan2, Yang Xue1, Chen Xiaobo1, Xia Xudong1,*   

  1. 1Henan Drug Reevaluation Center, Zhengzhou Henan 450008, China;
    2School of Pharmacy, Henan University, Kaifeng Henan 475000, China
  • Received:2026-02-10 Online:2026-09-15 Published:2026-09-15

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摘要： 目的 分析碘克沙醇注射液不良反应（ADR）发生规律及特点,为临床安全用药提供参考。方法 收集某市2020年1月1日至2025年6月30日上报怀疑药品为碘克沙醇注射液的ADR报告,分析患者的性别、年龄、ADR严重程度、累及器官-系统、给药途径及临床转归等情况。结果 1 358例ADR报告中,男性743例（54.71%）,女性615例（45.29%）,男女比例为1.21∶1。ADR以预期性反应为主,严重ADR占56.77%（771例）。累及系统-器官中,皮肤及皮下组织类疾病占比最高（1 938例次,89.81%）。给药途径以静脉注射最常见（765例,56.33%）。ADR发生主要集中在给药后24 h内,6~24 h为高发时段（319,41.37%）。不同剂量组的严重ADR与一般ADR比例分布差异具有显著统计学意义（P=0.027）。结论 碘克沙醇注射液所致ADR多为预期性且转归良好,但严重ADR发生率较高,临床应予以重视,重点关注中老年及合并多种基础疾病的患者。

关键词: 碘克沙醇注射液, 皮肤及皮下组织类疾病, 过敏性休克, 严重药品不良反应, 药品不良反应

Abstract: Objective To analyze the patterns and characteristics of adverse drug reactions (ADRs) associated with iodixanol injection, and to provide evidence for safe clinical use. Methods ADR reports submitted between January 1, 2020 and June 30, 2025 that involved iodixanol injection as the suspected drug were collected. Data on patients' gender, age, severity of ADRs, system organ classes (SOCs), routes of administration, and clinical outcomes was analyzed. Results Among the 1358 reports of ADRs, 743 (54.71%) involved males and 615 (45.29%) involved females, so the male-to-female ratio was 1.21∶1. Although the recorded ADRs were primarily expected reactions, severe ADRs made up 56.77% (771 cases). SOCs involved were mostly the skin and subcutaneous tissues (1 938 times, 89.81%). Intravenous injection was identified as the most common route of administration (765 cases, 56.33%). Most of the ADRs had an onset within 24 hours of administration, especially within 6-24 hour (319 cases, 41.37%). Furthermore, there was statistically significant difference in the proportion of severe and mild ADRs between different dosage groups (P=0.027). Conclusion ADRs induced by iodixanol injection are predominantly expected reactions and generally have favorable clinical outcomes. However, the proportion of severe ADRs remains high, which is a health concern. It is recommended that middle-aged and elderly patients as well as those with multiple underlying diseases be given special care.

Key words: Iodixanol Injection, Skin and Subcutaneous Tissue Disorders, Anaphylactic Shock, Severe Adverse Drug Reaction, Adverse Drug Reaction

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