基于美国FAERS数据库的碳青霉烯类抗菌药物相关神经系统不良事件分析  

Analysis on Carbapenems-Related Neurological Adverse Events Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database

作　　者：肖静 郭代红[2] 袁拥华[1] 高奥 李鹏[2] 伏安 李海艳 崔利强 XIAO Jing;GUO Daihong;YUAN Yonghua;GAO Ao;LI Peng;FU An;LI Haiyan;CUI Liqiang(College of Pharmacy,Chongqing Medical University,Chongqing 400016,China;Dept.of Pharmacy,Medical Supplies Center,Chinese PLA General Hospital,Beijing 100853,China)

机构地区：[1]重庆医科大学药学院,重庆400016 [2]中国人民解放军总医院医疗保障中心药剂科,北京100853

出　　处：《中国医院用药评价与分析》2025年第1期111-116,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：中国研究型医院学会专项基金资助项目(No.Y2023FH-YWPJ03)。

摘　　要：目的:探讨碳青霉烯类抗菌药物相关神经系统不良事件(nAE)的发生特点,挖掘风险信号,为临床合理用药提供参考。方法:提取美国食品药品监督管理局不良事件报告系统(FAERS)数据库中2004年第1季度至2023第4季度共80个季度的碳青霉烯类抗菌药物相关nAE报告,采用报告比值比、比例报告比、贝叶斯置信传播神经网络算法进行信号检测,对获取的风险信号进行分析比较。结果:共收集到碳青霉烯类抗菌药物相关nAE报告1637份。nAE多发生于用药后10 d内,49.73%的患者(814例)年龄≥65岁,10.32%的患者(169例)死亡。与碳青霉烯类抗菌药物联合应用例次数排序靠前的药品有万古霉素、奥美拉唑、丙戊酸钠、对乙酰氨基酚等。检测出亚胺培南的nAE风险信号34个,美罗培南的nAE风险信号17个,厄他培南的nAE风险信号55个,包含部分新的危及生命的不良事件,如脑梗死、脑出血、脑脓肿及脑水肿等。上述3种碳青霉烯类抗菌药物相关nAE报告中,例次数最多的风险信号均为痫性发作,且癫痫相关风险信号均较多。结论:碳青霉烯类抗菌药物可能与多种nAE相关,特别是某些中枢神经系统症状(如癫痫、意识障碍等),临床用药时应密切关注高龄、肾功能减退、有中枢神经系统病史的高风险人群,以最大限度地减少神经毒性。OBJECTIVE:To probe into the characteristics of carbapenems-related neurological adverse events(nAE),and to mine the risk signals,so as to provide reference for clinical rational medication.METHODS:A total of 80 quarterly reports of carbapenems-related nAE from the first quarter of 2004 to the fourth quarter of 2023 were extracted from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database.Signal detection was performed by using reporting odds ratio,proportional reporting ratio and Bayesian confidence propagation neural network algorithm,the risk signals obtained were analyzed and compared.RESULTS:A total of 1637 reports of carbapenems-related nAE were collected.Most nAE occurred within 10 days after administration,49.73%of patients(814 cases)aged≥65 years old,and 10.32%of patients(169 cases)died.The drugs with the highest number of cases of combined application with carbapenems were vancomycin,omeprazole,sodium valproate and acetaminophen,etc.A total of 34 risk signals for imipenem-related nAE,17 for meropenem-related nAE and 55 for ertapenem-related nAE were detected,including some of new life-threatening adverse events such as cerebral infarction,cerebral haemorrhage,cerebral abscess and cerebral edema.The risk signal with the highest number of reported cases were epileptic seizures for the above three kinds of carbapenems,and all had a higher number of epilepsy-related risk signals.CONCLUSIONS:Carbapenems may be associated with a variety of nAE,particularly certain central nervous system symptoms(such as epilepsy and consciousness disorders),close attention should be paid to high-risk populations with advanced age,renal hypofunction and history of central nervous system disorders in the clinic,so as to minimize the neurotoxicity.

关 键 词：碳青霉烯类抗菌药物 神经系统不良事件 药品不良反应 信号挖掘 

分 类 号：R969.3[医药卫生—药理学] R978.1[医药卫生—药学]