摘要
Abstract
AIM To mine and analyze drug adverse events(ADE)associated with bedaquiline,providing a basis for rational clinical use of bedaquiline.METHODS ADE reports related to bedaquiline were collected from the FDA adverse event reporting system(FAERS)database.The reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods in the disproportionality analysis were used to mine potential ADE signals.The selected ADE were standardized using the preferred term(PT)from the Medical Dictionary for Regulatory Activities(MedDRA),and classified according to the system organ class(SOC).RESULTS A total of 1 445 bedaquiline-related ADE reports were retrieved.After screening,129 positive signals were obtained,involving 18 SOCs.Among the top 20 ADE ranked by signal intensity,16 ADE were not mentioned in the drug label,including chronic pyelonephritis,cor pulmonale,ototoxicity,cardiopulmonary failure and vestibular disorder.Among the top 20 ADE ranked by frequency of occurrence,13 ADE were not mentioned in the drug label,including anemia,peripheral neuropathy,hypokalaemia,respiratory failure and gastrointestinal disorders.CONCLUSION The ADE of bedaquiline identified through data mining are partially consistent with those documented in the drug label,yet numerous novel ADE have been detected.In clinical practice,patients treated with bedaquiline should undergo regular monitoring for ear and labyrinth disorders,renal and urinary system disorders,and nervous system disorders,therefore,ADE can be identified and managed timely,ensuring medication safety.关键词
贝达喹啉/比例失衡法/美国食品和药品监督管理局不良事件上报系统/药品不良事件/药物警戒/信号挖掘Key words
bedaquiline/disproportionality analysis/FDA adverse event reporting system/drug adverse event/pharmacovigilance/data mining分类
医药卫生
