阿美替尼上市后不良反应分析

doi:10.19803/j.1672-8629.20240089

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (6): 683-686.
DOI: 10.19803/j.1672-8629.20240089

阿美替尼上市后不良反应分析

孙雪林¹, 杜娇², 谭琴³, 胡欣¹, 张亚同¹, 郑丽^4,*

¹北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京 100730;
²青岛市市立医院,山东青岛 266000;
³北京医院生物治疗中心,国家老年医学中心,中国医学科学院老年医学研究院,北京100730;
⁴中国航天科工集团七三一医院药学部,北京 100074

收稿日期:2024-02-02 出版日期:2024-06-15 发布日期:2024-06-18
通讯作者: ^*郑丽,女,博士,主管药师,循证医学与医学信息学。E-mail：zhenglis1270755@163.com
作者简介:孙雪林,女,博士,副主任药师,药物警戒与老年合理用药。
基金资助:
中央高水平医院临床科研业务费资助项目（BJ-2023-200）; 七三一医院院级科研基金（2022-QSYN-01）; 国家自然科学基金资助项目（82373272）

Analysis of post-marketing adverse reactions of ametinib

SUN Xuelin¹, DU Jiao², TAN Qin³, HU Xin¹, ZHANG Yatong¹, ZHENG Li^4,*

¹Department of Pharmacy, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China;
²Qingdao Municipal Hospital, Qingdao Shandong 266000, China;
³Center of Biotherapy, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China;
⁴Department of Pharmacy, China Aerospace Science & Industry Corporation 731 Hospital, Beijing 100074, China

Received:2024-02-02 Online:2024-06-15 Published:2024-06-18

摘要/Abstract

摘要： 目的分析第三代表皮生长因子受体-酪氨酸激酶抑制剂（epidermal growth factor receptor-tyrosine kinase inhibitor, EGFR-TKI）阿美替尼不良反应发生的规律及特点,为该药临床安全使用提供参考。方法计算机检索 PubMed、Embase、Web of Science、The Cochrane Library、中国知网、万方数据和中国生物医学文献服务系统数据库,对阿美替尼上市后不良反应文献进行分析,检索时限为建库至 2024 年 1 月16日。结果共纳入12篇文献,收集263名患者的安全性数据,据文献数据统计,阿美替尼所致不良反应共246例次,主要表现为皮疹/痤疮样皮疹（17.9%）、转氨酶增高（12.6%）、血液及淋巴系统疾病（6.1%）、全身乏力（5.7%）、甲沟炎（7.3%）等,共发生11例≥3级的不良反应,预后良好。结论阿美替尼的不良反应表现多样,对皮肤和肝功能的影响较为明显,应持续加强用药监测,警惕其不良反应发生。

关键词: 阿美替尼, 表皮生长因子受体-酪氨酸激酶抑制剂, 非小细胞肺癌, 不良反应, 文献分析, 合理用药

Abstract: Objective To analyze the incidence of adverse reactions of the third-generation EGFR-TKI aumolertinib, and to provide reference for rational use of the drug in clinic. Methods PubMed, Embase, Web of Science, The Cochrane Library, CNKI, and WanFang Data and SinoMed database were searched to retrieve the literature on post-marketing adverse reactions of aumolertinib that was published from the inception to 16 January 2024 and to perform statistical analyses. Results A total of 12 articles were included in the study, and data on safety was collected from 263 patients. There were 246 adverse reactions caused by ametinib, which were mainly manifested as rash/acne-like rash (17.9%), increased transaminases (12.6%), onychomycosis (7.3%), haematological and lymphatic system disorders (6.1%), and generalized malaise (5.7%). A total of 11 adverse reactions ≥ grade 3 occurred, and the prognosis was good. Conclusion The adverse reactions of aumolertinib have diverse manifestations, and the effect on the skin and liver function is more obvious. Clinicians are advised to be alert to the occurrence of adverse reactions.

Key words: aumolertinib, EGFR-TKI, non-small cell lung cancer, adverse reactions, literature analysis, rational drug use

中图分类号:

R994.11

孙雪林, 杜娇, 谭琴, 胡欣, 张亚同, 郑丽. 阿美替尼上市后不良反应分析[J]. 中国药物警戒, 2024, 21(6): 683-686.

SUN Xuelin, DU Jiao, TAN Qin, HU Xin, ZHANG Yatong, ZHENG Li. Analysis of post-marketing adverse reactions of ametinib[J]. Chinese Journal of Pharmacovigilance, 2024, 21(6): 683-686.

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阿美替尼上市后不良反应分析

Analysis of post-marketing adverse reactions of ametinib

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