中国药房2024，Vol.35Issue(9)：1123-1128,6.DOI:10.6039/j.issn.1001-0408.2024.09.17
3种第三代四环素类抗菌药物ADE信号的挖掘与分析
Data mining and analysis for ADE signals of three third-generation tetracycline antibiotics
摘要
Abstract
OBJECTIVE To excavate the adverse drug event(ADE)signals of three third-generation tetracycline antibiotics(tigecycline,omadacycline,eravacycline)based on FDA adverse event reporting system(FAERS),and to provide reference for the safe use of them.METHODS The ADE reports of tigecycline,omadacycline and eravacycline from the first quarter of 2005 to the second quarter of 2023 were retrieved from FAERS database.The ADE signals of 3 kinds of drugs were mined by the method of reporting odds ratio method and the proportional reporting ratio method.RESULTS Totally 2 538 ADE reports with tigecycline,omadacycline and eravacycline as the primary suspected drugs were obtained,including 2 135 tigecycline ADE reports,349 omadacycline ADE reports and 54 eravacycline ADE reports.A total of 131 ADE positive signals of tigecycline were mined,involving 19 system organ classes(SOCs),mainly concentrated in investigations,hepatobiliary system,blood and lymphatic system,and gastrointestinal system,etc;the preferred terminologies(PT)with intense signal were hypofibrinogenaemia and blood fibrinogen decreased.Fourteen ADE signals were not mentioned in the drug instruction,such as renal failure,acute kidney injury and hemorrhage.Totally 24 ADE positive signals of omadacycline were mined,involving 6 SOCs,mainly concentrated in the gastrointestinal system and various examinations;the PTs with intense signals were tooth discoloration,jet-like vomiting and loose feces,etc.ADE signals were not mentioned in the drug instructions,included lip swelling,gastroesophageal reflux disease,eosinophilia,skin discoloration,feces softening,and night sweats.Five ADE positive signals of eravacycline were mined,involving 4 SOCs,mainly concentrated in various examinations,gastrointestinal system,etc.The most intense ADE signals were blood fibrinogen decreased and hypofibrinogenaemia.CONCLUSIONS ADE of the gastrointestinal system are mostly identified in the three third-generation tetracycline antibiotics,especially pancreatitis caused by tigecycline and gastroesophageal reflux disease caused by oral administration of omadacycline.The liver function,renal function(for tigecycline)and coagulation function(for tigecycline,eravacycline)should be monitored regularly during medication,so as to prevent the occurrence of serious ADE.关键词
替加环素/奥马环素/依拉环素/药物不良事件/信号挖掘/胰腺炎/胃食管反流病/FAERS数据库Key words
tigecycline/omadacycline/eravacycline/drug adverse event/signaling mining/pancreatitis/gastroesophageal reflux disease/FAERS database分类
医药卫生引用本文复制引用
梁碧怡,杨惠霞,黄小梅,任剑雄..3种第三代四环素类抗菌药物ADE信号的挖掘与分析[J].中国药房,2024,35(9):1123-1128,6.基金项目
佛山市科技局科技创新项目(No.2220001005371) （No.2220001005371）
