中国药物警戒 ›› 2022, Vol. 19 ›› Issue (1): 83-86.
DOI: 10.19803/j.1672-8629.2022.01.18

• 安全与合理用药 • 上一篇    下一篇

110例碘克沙醇药品不良反应分析

张丹1, 李黎1, 许恒伟2, 朱亚宁1, 张鹏1, 周楠1,*   

  1. 1陕西省人民医院药学部,陕西 西安 710068;
    2陕西省人民医院心血管内一科,陕西 西安 710068
  • 收稿日期:2020-03-16 出版日期:2022-01-15 发布日期:2022-01-20
  • 通讯作者: *周楠,女,博士,主管药师,神经内科。E-mail：zhounan.ni@163.com
  • 作者简介:张丹,女,硕士,主管中药师,心血管。
  • 基金资助:
    基金资助：国家自然科学基金青年科学基金项目（81703514）

Observation of 110 cases of adverse drug reactions induced by iodixanol

ZHANG Dan1, LI Li1, XU Hengwei2, ZHU Yaning1, ZHANG Peng1, ZHOU Nan1,*   

  1. 1Department of Pharmacy, Shaanxi Provincial People's Hospital, Xi'an Shaanxi 710068, China;
    2Department of Cardiology, Shaanxi Provincial People's Hospital, Xi'an Shaanxi 710068, China
  • Received:2020-03-16 Online:2022-01-15 Published:2022-01-20

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摘要： 目的 分析碘克沙醇在血管造影应用中发生药品不良反应（adverse drug reaction, ADR）的特点及规律,为减少临床用药风险提供参考。方法 临床药师对我院心内科2018年7月1日至2019年5月31日使用碘克沙醇的415例患者进行药学监护,询问并记录患者使用碘克沙醇后ADR发生的时间、症状及程度,利用医院信息管理系统（HIS）检索患者其他信息,包括性别、年龄、体重、肌酐值等。结果 415例患者中有359例患者录入ADR相关有效信息,发生ADR的患者共计110例,ADR总体发生率30.64%。其中急发ADR占不良反应总数的14.55%,迟发占85.45%;轻度占73.64%,中度占25.45%,重度占0.91%;按ADR累及系统-器官统计共计181例次,皮肤及其附件损害占25.41%,消化系统占27.62%,神经系统占24.31%,心血管系统占3.87%,呼吸系统占9.39%,泌尿系统占1.10%,全身ADR占8.29%。过敏性休克1例,对比剂所致的急性肾损伤（contrast induced acute kidney injury, CI-AKI）2例。结论 碘克沙醇相关ADR发生率高于既往报道,应加强术前预防评估及各项措施,降低ADR发生率,提高用药安全性。

关键词: 碘克沙醇, 药品不良反应, 碘对比剂, 急性肾损伤

Abstract: Objective To analyze the characteristics and patterns of adverse drug reactions (ADR) caused by iodixanol during angiography, and to provide reference for control of risks of clinical medications. Methods A clinical pharmacist performed pharmacy monitoring of 415 patients who used iodixanol between July 1, 2018 and May 31, 2019 in the Cardiology Department of Shaanxi Provincial People's Hospital. Patients were asked while the time ADR occurred, symptoms and severity of ADR after using iodixanol were recorded. Other information including gender, age, weight, and levels of creatinine was retrieved with the HIS. Results Among the 415 patients, 359 entered valid information of ADR, A total of 110 patients developed ADR. The overall rate was 30.64%, compared with 14.55% for immediate reactions, 85.45% for delayed reactions, 73.64% for mild reactions, 25.45% for moderate reactions, and 0.91% for severe reaction. According to the statistics, there were a total of 181 cases of ADR involving systems and organs. Damage to the skin and its accessories accounted for 25.41%, 27.62% for the digestive system, 24.31% for the nervous system, 3.87% for the cardiovascular system, 9.39 % for the respiratory system, and 1.10% for the urinary system. Systemic adverse reactions made up 8.29%. One patient had anaphylactic shock, and two suffered from contrast-induced acute kidney injury (CI-AKI). Conclusion The incidence of adverse drug reactions associated with iodixanol is higher than was previously reported. Preoperative preventive evaluation and measures should be enhanced to reduce the incidence of adverse reactions and improve the safety of medications.

Key words: iodixanol, adverse drug reaction, iodine contrast agent, acute kidney injury

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