基于FDA不良事件报告系统数据库的新型四环素类抗菌药物不良反应信号比值失衡分析  

Disproportionality analysis of adverse reaction signals for novel tetracycline antibiotics based on the FDA adverse event reporting system database

作　　者：刘碧晴 白向荣[2] LIU Biqing;BAI Xiangrong(Department of Pharmacy,Children's Hospital Affiliated to Capital Institute of Pediatrics,Beijing 100020,China;Department of Pharmacy,Xuanwu Hospital of Capital Medical University,Beijing 100053,China)

机构地区：[1]首都儿科研究所附属儿童医院药学部,北京100020 [2]首都医科大学宣武医院药学部,北京100053

出　　处：《临床药物治疗杂志》2024年第12期46-53,共8页Clinical Medication Journal

基　　金：北京市属医院科研培育计划项目(PX2020038)。

摘　　要：目的通过FDA不良事件报告系统(FAERS)数据库,挖掘新型四环素类抗菌药物替加环素、奥玛环素和依拉环素的不良反应信号,为临床安全用药提供参考。方法采用报告比值比(ROR)法、英国药品和健康产品管理局(MHRA)综合标准法和贝叶斯可信区间递进神经网络(BCPNN)法,对FAERS数据库2004年第1季度至2024年第2季度以替加环素、奥玛环素和依拉环素为首要怀疑药物的不良反应进行挖掘和分析。结果共收集新型四环素类抗菌药物不良反应报告3007例,其中替加环素2372例,奥玛环素552例,依拉环素83例,排除与药物治疗无关的信号,经ROR法、MHRA综合标准法和BCPNN法共挖掘到替加环素不良反应信号115个,涉及16个系统器官分类(SOC);奥玛环素不良反应信号22个,涉及9个SOC;依拉环素不良反应信号8个,涉及4个SOC。累计不良反应报告2785例次,主要涉及各类检查、胃肠系统疾病、血液及淋巴系统疾病、肝胆系统疾病等。替加环素信号强度排名前5位的首选术语(PT)为低纤维蛋白原血症、血纤维蛋白原降低、凝血酶时间延长、淀粉酶异常、入睡障碍;奥玛环素排名前5位的PT为输液部位静脉炎、牙齿变色、喷射样呕吐、肝功能异常、舌变色;依拉环素排名前5位的PT为血纤维蛋白原降低、低纤维蛋白原血症、胰酶升高、静脉炎、凝血酶原时间延长。结论3种新型四环素类抗菌药物在血液系统和消化系统部分不良反应风险存在差异,药品说明书未记载的部分不良反应与神经系统和光毒性有关。临床应根据相关特点进行药物选择、用药监护及指导。Objective To investigate and analyze adverse drug reaction signals of novel tetracycline antibiotics,including tigecycline,omadacycline,and eravacycline,using the FDA adverse event reporting system(FAERS)database to provide a reference for safer clinical drug use.Methods The reporting odds ratio(ROR),the Medicines and Healthcare Products Regulatory Agency(MHRA)combined standard,and the Bayesian confidence propagation neural network(BCPNN)methods were used to mine and analyze adverse drug reactions in the FAERS database from the first quarter of 2004 to the second quarter of 2024,focusing on tigecycline,omadacycline,and eravacycline as primary suspect drugs.Results A total of 3007 adverse drug reaction reports related to novel tetracycline antibiotics were collected from the FAERS database,including 2372 reports for tigecycline,552 for omadacycline,and 83 for eravacycline.After excluding signals unrelated to drug therapy,115 ADR signals for tigecycline were identified,involving 16 system organ classes(SOCs),22 signals for omadacycline involving 9 SOCs,and 8 signals for eravacycline involving 4 SOCs.Among the 2785 cumulative reports,the primary adverse drug reactions were associated with laboratory abnormalities,gastrointestinal disorders,blood and lymphatic system disorders,and hepatobiliary disorders.The top five preferred terms(PTs)ranked by signal strength for tigecycline were hypofibrinogenemia,decreased blood fibrinogen,prolonged thrombin time,abnormal amylase,and insomnia.For omadacycline,the top five PTs were infusion site phlebitis,tooth discoloration,projectile vomiting,abnormal liver function,and tongue discoloration.For eravacycline,the top five PTs were decreased blood fibrinogen,hypofibrinogenemia,elevated pancreatic enzymes,phlebitis,and prolonged prothrombin time.Conclusion The three novel tetracycline antibiotics exhibit varying risks of adverse reactions in the hematological and gastrointestinal systems.Some adverse reactions,particularly those related to the nervous system and phototoxicity,are n

关 键 词：FDA不良事件报告系统数据库 四环素类抗菌药物 数据挖掘 不良反应 

分 类 号：R978.1[医药卫生—药品]