摘要
目的基于美国食品药品管理局不良事件报告系统(FAERS)数据库对新型抗耐多药结核(MDR-TB)药品不良事件(ADE)进行挖掘与分析,探索其ADE信号,为临床安全用药提供参考。方法检索并提取FAERS数据库2015年第一季度至2023年第四季度收录的目标药物贝达喹啉、德拉马尼和普托马尼的ADE报告,利用报告比值比法(ROR)、比例报告比法(PRR)、标准综合法(MHRA)及贝叶斯置信度递进神经网络法(BCPNN)对相关ADE进行数据挖掘和分析。结果贝达喹啉、德拉马尼、普托马尼ADE报告数分别为2477、1630、173份,ADE累及多个系统器官,经ROR、PRR、MHRA、BCPNN法分别检测出阳性信号246、246、215、204个(贝达喹啉);251、251、224、200个(德拉马尼);25、25、24、22个(普托马尼)。临床参考意义大的高风险信号包括心电图QT间期延长、贫血、肝脏毒性、周围神经病等。结论基于FAERS不良事件信号挖掘显示,贝达喹啉、德拉马尼、普托马尼在临床使用中需密切关注心电图QT间期延长、贫血、肝脏毒性、周围神经病等风险,除此之外,新的潜在ADE信号(如急性心力衰竭、呼吸衰竭、急性肾损伤等)也应加强监测,并及时采取干预措施,以保证用药安全。
Objective To mine and analyze adverse drug events(ADEs)of novel agents for multi-drug-resistant tuberculosis(MDR-TB)based on the FDA Adverse Event Reporting System(FAERS)database,to explore the signals of ADEs,and to provide reference for clinical use.Methods The FAERS database was searched and extracted from Q1 of 2015 to Q4 of 2023,and the ADE reports about bedaquiline,delamanid,and pretomanid were collected.Data mining and analysis were carried out on relevant reports of the drug using the reporting odds ratio(ROR),proportional reporting ratio(PRR),medicines and healthcare products regulatory agency(MHRA),and the Bayesian confidence progressive neural network(BCPNN).Results The number of ADE reports for the target drugs bedaquiline,delamanid,and pretomanid were 2477,1630,and 173,respectively.ADE of the target drugs involved multiple organ systems.Positive signals detected by the ROR,PRR,MHRA,and BCPNN methods were 246,246,215,204 for bedaquiline;251,251,224,200 for delamanid;and 25,25,24,22 for pretomanid.Clinically significant high-risk signals include prolonged QT interval on ECG,anemia,liver toxicity,peripheral neuropathy,etc.Conclusions The signal mining of ADEs based on the FAERS database indicates that close attention should be paid to risks such as prolonged QT interval on ECG,anemia,liver toxicity,and peripheral neuropathy during the clinical use of bedaquiline,delamanid,and pretomanid.In addition,monitoring of new potential ADE signals(such as acute heart failure,respiratory failure,acute kidney injury,etc.)should be strengthened,and timely intervention measures should be taken to ensure medication safety.
作者
赵丽玲
李君霞
陈爽
赵唯炜
杨海鹏
谢若函
曾莉
ZHAO Liling;LI Junxia;CHEN Shuang;ZHAO Weiwei;YANG Haipeng;XIE Ruohan;ZENG Li(Department of Pharmacy,Henan Provincial Chest Hospital(Chest Hospital of Zhengzhou University),Zhengzhou 450008,China;Department of Pharmacy,the Fifth People's Hospital of Wuxi City(Affiliated Wuxi Fifth Hospital of Jiangnan University),Wuxi 214007,China)
出处
《医药导报》
北大核心
2025年第9期1456-1464,共9页
Herald of Medicine
