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

作　　者：梁碧怡[1] 杨惠霞[1] 黄小梅[1] 任剑雄[1] LIANG Biyi;YANG Huixia;HUANG Xiaomei;REN Jianxiong(Clinical Pharmacy Room,Foshan Hospital of Traditional Chinese Medicine,Guangdong Foshan 528000,China)

机构地区：[1]佛山市中医院临床药学室,广东佛山528000

出　　处：《中国药房》2024年第9期1123-1128,共6页China Pharmacy

基　　金：佛山市科技局科技创新项目(No.2220001005371)。

摘　　要：目的基于美国FDA不良事件报告系统(FAERS)数据库,挖掘3种第三代四环素类抗菌药物(替加环素、奥马环素、依拉环素)的药物不良事件(ADE)信号,为临床安全使用该类药物提供依据。方法检索美国FAERS数据库中2005年第1季度至2023年第2季度替加环素、奥马环素、依拉环素的ADE报告,采用报告比值比法和比例报告比值法对3种药物的ADE信号进行挖掘,并进行分析。结果共获得以替加环素、奥马环素、依拉环素为首要怀疑药物的ADE报告2538份,其中替加环素2135份、奥马环素349份、依拉环素54份。替加环素的ADE阳性信号有131个,共涉及19个系统器官分类(SOC),主要集中在各类检查、肝胆系统疾病、血液及淋巴系统疾病、胃肠系统疾病等;信号较强的首选术语(PT)分别是低纤维蛋白原血症和血纤维蛋白原降低等;肾衰、急性肾损伤、出血等14种ADE在其说明书中未提及。奥马环素的ADE阳性信号有24个,共涉及6个SOC,主要集中在胃肠系统疾病、各类检查等;信号较强的PT分别是牙齿变色、喷射样呕吐、粪便松软等;其说明书未提及的ADE有唇部肿胀、胃食管反流病、嗜酸粒细胞增多症、皮肤变色、粪便松软、盗汗。依拉环素的ADE阳性信号有5个,共涉及4个SOC,主要集中在各类检查、胃肠系统疾病等;信号较强的PT分别是血纤维蛋白原降低和低纤维蛋白原血症。结论3种第三代四环素类药物涉及胃肠系统的ADE最多,使用时尤其要注意替加环素所致胰腺炎类疾病和奥马环素口服所致胃食管反流病的ADE。在用药期间应定期监测患者肝功能、肾功能(使用替加环素时)、凝血功能(使用替加环素、依拉环素时),以防范严重ADE的发生。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 2538 ADE reports with tigecycline,omadacycline and eravacycline as the primary suspected drugs were obtained,including 2135 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 gastroe

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 

分 类 号：R978.14[医药卫生—药品]