摘要
Abstract
AIM To explore and analyze adverse event signals associated with enzalutamide in the U.S.FDA Adverse Event Reporting System(FAERS)database,aiming to provide a reference for the clinical safety and rational use of enzalutamide.METHODS Adverse drug events(ADE)of enzalutamide from the third quarter of 2012 to the first quarter of 2023 were collected using the FAERS database,and ADE signal exploration was conducted using the Bayesian confidence interval progressive neural network(BCPNN)method,and the reporting odds ratio method(ROR).RESULTS A total of 127 429 ADE reports with enzalutamide as the primary suspected drug were extracted,involving 44 226 cases.A total of 287 valid signals were explored,affecting 23 systematic organ classifications(SOC).The proportion of males was 98.02％.The majority of individuals were over 65 years old(49.41％).And primary reporting country was the United States(83.68％).The involved SOC primarily included various neurological disorders,renal and urinary disorders,injury,poisoning and procedural complications,benign,malignant and unspecified tumors(including cysts and polyps),as well as gastrointestinal disorders,etc.The most frequently reported ADE signals included fatigue(7 667 cases),death(7 031 cases),and malignant neoplasm progression(4 593 cases).A total of 73 previously unrecorded potential adverse reactions were identified,including malignant neoplasm progression,dysphagia,epilepsy,etc.CONCLUSIONS The utilization of the FAERS database can offer a more comprehensive insight into the post-marketing adverse effects of enzalutamide,promoting rational clinical application and ensuring the safety and efficacy of drug use for patients.关键词
恩扎卢胺/FAERS数据库/药物不良事件/信号/数据挖掘Key words
enzalutamide/FAERS database/adverse drug event/signal/data exploration
