摘要
Abstract
OBJECTIVE:To explore and evaluate the safety signals of docetaxel after marketing,and to provide basis for rational clinical drug use.METHODS:Reports of adverse drug events(ADE)related to docetaxel from Sept.30th,2013 to Feb.29th,2024 were extracted from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database.The report odds ratio method and the Bayesian confidence interval progressive neural network method were applied to mine and screen the ADE risk signals related to docetaxel.The obtained ADE risk signals were compared and analyzed with the drug instructions.RESULTS:A total of 663 ADE risk signals related to docetaxel were identified,involving 26 kinds of system organ class,mainly including skin and subcutaneous tissue diseases,psychiatric disorders,systemic diseases,various reactions at the administration site,blood and lymphatic system diseases.A total of 21 newly discovered suspected adverse drug reactions were found,mainly including psychological trauma,aortic inflammation,osteitis densa,abnormal estradiol,positive ALK gene rearrangement,abnormal bronchoscopy,and lipidosis.CONCLUSIONS:The common adverse drug reactions related to docetaxel in the real world are consistent with the drug instructions,yet there are some newly suspected adverse drug reactions,which should be paid attention to in clinical practice.关键词
多西他赛/比例失衡法/药品不良事件/数据挖掘Key words
Docetaxel/Proportional imbalance method/Adverse drug event/Data mining分类
医药卫生
