Literature analysis of adverse drug reactions induced by afatinib dimaleate
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.
万方数据
维普
