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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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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.
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.

aumolertinibEGFR-TKInon-small cell lung canceradverse reactionsliterature analysisrational drug use

孙雪林、杜娇、谭琴、胡欣、张亚同、郑丽

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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

青岛市市立医院,山东 青岛 266000

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

中国航天科工集团七三一医院药学部,北京 100074

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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

中央高水平医院临床科研业务费资助项目七三一医院院级科研基金国家自然科学基金资助项目

BJ-2023-2002022-QSYN-0182373272

2024

中国药物警戒
国家药品监督管理局药品评价中心(国家药品不良反应监测中心)

中国药物警戒

CSTPCD
影响因子:1.105
ISSN:1672-8629
年,卷(期):2024.21(6)