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。
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.
作者
孙雪林
杜娇
谭琴
胡欣
张亚同
郑丽
SUN Xuelin;DU Jiao;TAN Qin;HU Xin;ZHANG Yatong;ZHENG Li(Department of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Qingdao Municipal Hospital,Qingdao Shandong 266000,China;Center of Biotherapy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Pharmacy,China Aerospace Science&Industry Corporation 731 Hospital,Beijing 100074,China)
出处
《中国药物警戒》
2024年第6期683-686,共4页
Chinese Journal of Pharmacovigilance
基金
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)。
