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 data-base,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 out-come,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%),diges-tive system(5 cases,20.00%),cardiovascular system(1 case,4.00%)and eyes(1 case,4.00%).After23 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 gastrointestinal bleeding and withdrew afatinib and improved after symptomatic treatment;1 patient withdrew afatinib,but the treatment and outcome were not mentioned.Conclusion Patients equal or above 61 are more likely to suffer from adverse drug reactions after using afa-tinib,and most of adverse drug reactions occur within 1 month after treatment.Adverse drug reactions involves many or-gans/systems,mainly skin and its appendants,followed by respiratory system,digestive system.We should strengthen the monitoring in clinical application of afatinib in order to ensure the safety and effectiveness of medication use.
维普
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