215例小分子激酶抑制剂药品不良反应分析

doi:10.19803/j.1672-8629.2022.05.16

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (5): 550-553.
DOI: 10.19803/j.1672-8629.2022.05.16

215例小分子激酶抑制剂药品不良反应分析

范倩倩¹, 张波¹, 赵彬¹, 李秋月¹, 刘芳¹, 马杰^2,*

¹中国医学科学院北京协和医院药剂科,北京 100730;
²中国医学科学院北京协和医院肾内科,北京 100730

收稿日期:2020-06-28 出版日期:2022-05-15 发布日期:2022-05-18
通讯作者: ^*马杰,男,硕士,副主任医师,肾脏内科。
作者简介:范倩倩,女,博士,主管药师,药物利用与安全性评价。
基金资助:
中华医学会临床药学分会-吴阶平医学基金会科研专项基金（320.6750.19090-30）

215 cases of adverse drug reactions related to small molecule kinase inhibitors

FAN Qianqian¹, ZHANG Bo¹, ZHAO Bin¹, LI Qiuyue¹, LIU Fang¹, MA Jie^2,*

¹Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China;
²Department of Nephrology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China

Received:2020-06-28 Online:2022-05-15 Published:2022-05-18

摘要/Abstract

摘要： 目的探讨小分子激酶抑制剂（small molecule kinase inhibitors, SMKIs）的药品不良反应（adverse drug reaction, ADR）的发生特点,为安全合理用药提供参考。方法回顾中国医学科学院北京协和医院2012年10月1日至2019年4月30日接受SMKIs治疗后发生ADR的住院患者病历,从患者基本情况、药品使用情况、ADR发生情况等方面进行分析。结果共215例患者发生SMKIs相关ADR,男女性别比为1.29∶1,平均年龄（58.91±13.75）岁;涉及17种SMKIs,按照ADR构成比排序前5位的药品依次为厄洛替尼（20.47%）、吉非替尼（16.74%）、舒尼替尼（14.42%）、伊马替尼（12.56%）和索拉非尼（12.09%）;ADR累及多个系统-器官,以皮肤及其附件（35.62%）和消化系统（31.05%）损害最为常见,多为一般ADR,亦有严重而导致停药的情况。结论 SMKIs相关ADR可累及多个系统-器官,应加强监测,早期识别和干预有助于提高靶向治疗的依从性和疗效。

关键词: 靶向药物, 小分子激酶抑制剂, 药品不良反应

Abstract: Objective To investigate the characteristics of adverse drug reaction (ADR) related to small molecule kinase inhibitors (SMKIs), and provide reference for safe and rational use of drugs. Methods The medical records of inpatients in our hospital who had developed ADR after SMKI treatments between October 1st 2012 and April 30th 2019 were collected and reviewed. The demographics of patients, suspected drug use and clinical characteristics of ADR were analyzed. Results A total of 215 patients developed ADR secondary to SMKI treatments. The ratio of males to females was 1.29∶1 and the average age was 58.91±13.75 years. Seventeen types of SMKIs were involved, and the top five were erlotinib (20.47%), gifitinib (16.74%), sunitinib (14.42%), imatinib (12.56%) and sorafenib (12.09%) according to the proportions of ADR. Multiple systems-organs were implicated in ADR related to SMKIs, and impairments in the skin and its accessories (35.62%) and in the digestive system (31.05%) weres prevalent. Most of these cases were common ADR, but there were severe ones that led to drug discontinuation. Conclusion SMKI-related ADR can possibly involve multiple systems/organs. Close monitoring, early detection and intervention are required to improve patients' compliance and clinical efficacy of targeted therapies.

Key words: targeted drug, small molecule kinase inhibitor, adverse drug reaction

中图分类号:

R994.11

范倩倩, 张波, 赵彬, 李秋月, 刘芳, 马杰. 215例小分子激酶抑制剂药品不良反应分析[J]. 中国药物警戒, 2022, 19(5): 550-553.

FAN Qianqian, ZHANG Bo, ZHAO Bin, LI Qiuyue, LIU Fang, MA Jie. 215 cases of adverse drug reactions related to small molecule kinase inhibitors[J]. Chinese Journal of Pharmacovigilance, 2022, 19(5): 550-553.

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215例小分子激酶抑制剂药品不良反应分析

215 cases of adverse drug reactions related to small molecule kinase inhibitors

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