摘要
目的:基于FAERS数据库对老年患者应用布洛芬和对乙酰氨基酚的上市后药品不良事件(ADE)报告进行信号挖掘。方法:使用OpenVigil 2.1平台,提取FAERS数据库中65岁以上老年患者使用布洛芬/对乙酰氨基酚的上市后ADE报告,采用报告比值比法和贝叶斯法进行数据挖掘,进一步分析筛选出的中强信号及强信号。结果:老年患者中,布洛芬信号最强的ADE为暂时性耳聋,对乙酰氨基酚信号最强的ADE为自杀既遂。重点系统中,布洛芬在肾脏及泌尿系统疾病、胃肠系统中检出较多强信号;对乙酰氨基酚在肝胆系统疾病、呼吸系统、精神病类检出较多强信号。结论:在新型冠状病毒感染居家治疗期间,对于低烧或者有呼吸系统、肝胆系统、肾脏及泌尿系统、心脏系统等严重基础疾病的老年患者,慎用布洛芬和对乙酰氨基酚。对于高烧不退的老年患者且有肾脏及泌尿系统、胃肠系统等基础疾病者,使用布洛芬的风险大于对乙酰氨基酚;而对于有肝胆系统、呼吸系统、精神病、心脏器官疾病等基础疾病者,使用对乙酰氨基酚的风险大于布洛芬。
Objective:To mine the signal of post-marketing adverse drug events of ibuprofen and acetaminophen in elderly patients based on FAERS database.Methods:The OpenVigil 2.1 platform was used to extract post-marketing ADE reports of ibuprofen/acetaminophen patients over 65 years old from FAERS database.The reporting odds ratio and Bayesian method were used for data mining to further analyze the screened moderate and strong signals.Results:In elderly patients,the strongest ADE signal of ibuprofen was temporary deafness,the strongest ADE signal of acetaminophen was suicidal.Among the key systems,ibuprofen was detected more strong signals in kidney and urinary system and gastrointestinal system.Acetaminophen was detected more strong signals in the liver and biliary system disease,respiratory system and psychosis.Conclusion:During home treatment for COVID-19,ibuprofen and acetaminophen should be used with caution in elderly patients with low-grade fever or serious underlying diseases such as respiratory,hepatobiliary,kidney,urinary,and cardiac systems.For elderly patients with high fever,if with kidney and urinary system,gastrointestinal system and other basic diseases,the risk of using ibuprofen is greater than acetaminophen.For the ones with liver and biliary system,respiratory system,mental disease,heart organ disease and other basic diseases,the use of acetaminophen risk is greater than ibuprofen.
作者
王宇婷
郑靖萍
吕军
宿凌
WANG Yuting;ZHENG Jingping;LYU Jun;SU Ling(College of Pharmacy,Jinan University,Guangzhou 511443,Guangdong,China;Department of Clinical Research,the First Affiliated Hospital of Jinan University,Guangzhou 510630,Guangdong,China;Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Informatization,Guangzhou 510632,Guangdong,China)
出处
《暨南大学学报（自然科学与医学版）》
CAS
北大核心
2023年第2期211-218,226,共9页
Journal of Jinan University(Natural Science & Medicine Edition)
基金
广东省药品监督管理局科技创新项目(2022TDZ20)
广东省科技计划项目(2021B1212040007)。
