马来酸阿法替尼致不良反应的文献分析  

Literature analysis of adverse drug reactions induced by afatinib dimaleate

作　　者：吴彩霞 杨晰 王松[1] 陈娟娟[1] 司方莹[1] WU Caixia;YANG Xi;WANG Song;CHEN Juanjuan;SI Fangying(Department of Pharmacy,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院药学部,河南郑州450052

出　　处：《肿瘤基础与临床》2024年第4期398-404,共7页journal of basic and clinical oncology

摘　　要：目的分析马来酸阿法替尼致不良反应的临床表现和特点,为临床合理安全用药提供参考。方法检索中国知网数据库、万方数据库、维普数据库、PubMed、Web of Science数据库,检索时限为建库起至2022年5月,收集马来酸阿法替尼致不良反应文献的个案报道和病例系列报道,采用描述性统计方法对患者的一般情况、不良反应发生时间、累及器官/系统、临床表现、治疗和转归等情况进行分析和总结。结果共纳入文献21篇,合计23例患者,共涉及25种不良反应(其中2例患者发生2种不良反应)。患者的年龄为32~83岁,其中≥61岁患者所占比例最大(56.52%);其中男11例(47.83%),女12例(52.17%);患者主要来源于亚洲国家和地区(19例,82.61%);用药1个月内出现不良反应的例数最多(13例,52.00%);不良反应累及器官/系统以皮肤及附件(11例,44.00%)最为多见,其次为呼吸系统(7例,28.00%)、消化系统(5例,20.00%)、心血管系统(1例,4.00%)、眼(1例,4.00%)。23例患者中,13例患者停药,经对症治疗后好转;1例患者停药,自然好转;2例患者未停用药物,其中1例患者因可耐受该不良反应未行特殊处理,另1例患者经对症治疗后好转;3例患者停药,经对症治疗后死亡;2例患者未提及是否停用药物,其中1例经对症治疗后好转,另1例经对症治疗后死亡;1例患者出现严重皮肤不良反应,未停用药物,经对症治疗后好转,然后又出现胃肠道出血,停药并经对症治疗后好转;1例患者停药,但未提及治疗及转归。结论61岁及以上患者使用阿法替尼后更容易发生不良反应,并且不良反应多发生于用药后1月内。阿法替尼致不良反应涉及全身多个器官/系统,以皮肤及附件、呼吸系统、消化系统为主,临床中应加强用药过程中的监测,保证临床用药的安全性和有效性。Objective To investigate the clinical feature and characteristics of adverse drug reactions induced by afatinib dimaleate,and to provide reference for clinical rational drug use.Methods Retrieved from CNKI,Wanfang database,VIP,PubMed,Web of Science database during database establishment to May.2022,case reports and case series of afatinib-induced adverse drug reactions were collected and analyzed with descriptive statistical analysis method in respects of general information,occurrence time of adverse drug reaction,involved organ/system,clinical feature,treatment and outcome,etc.Results A total of 21 literatures were included,involving 23 patients and 25 cases(two of the patients occurred two adverse drug reactions individually).The age of patients were 32-83 years old,and the proportion of patients aged equal or above 61 was the largest(56.52%).Among them,11 cases(47.83%)were males,and 12 cases(52.17%)were females.The patients mainly were from Asian countries and regions(19 cases,82.61%).The most cases(13 cases,52.00%)occurred within 1 month of medication.Organs/systems involved in afatinib induced adverse drug reactions were mainly involved skin and its appendants(11 cases,44.00%),followed by respiratory system(7 cases,28.00%),digestive system(5 cases,20.00%),cardiovascular system(1 case,4.00%)and eyes(1 case,4.00%).After 23 patients suffered from adverse drug reactions,13 patients withdrew afatinib and improved after symptomatic treatment;1 patient withdrew afatinib and improved without any treatment;2 patients continued afatinib among which 1 patient could tolerance the adverse drug reactions and 1 patient improved after symptomatic treatment;3 patients withdrew afatinib and died after symptomatic treatment;2 patients did not mention whether they had withdrew afatinib,among which 1 patient improved and the other one died after symptomatic treatment;1 patient appeared severe skin adverse drug reactions in the beginning,she continued afatinib and improved after symptomatic treatment,but then suffered from gastr

关 键 词：阿法替尼 不良反应 文献分析 

分 类 号：R730.6[医药卫生—肿瘤]