基于FAERS的哌拉西林他唑巴坦不良事件信号挖掘与分析  

Data-mining of piperacillin-tazobactam related adverse drug event signals based on FAERS

作　　者：刘金伟[1] 董俊丽[1] 邵钰 张韶辉[1] LIU Jinwei;DONG Junli;SHAO Yu;ZHANG Shaohui(Department of Pharmacy,Wuhan NO.1 Hospital,Wuhan 430022,China;Department of Pharmacy,Changpin District Hospital of Traditional Chinese Medicine,Beijing 102200,China)

机构地区：[1]武汉市第一医院药学部,武汉430022 [2]北京市昌平区中医医院药剂科,北京102200

出　　处：《中国药师》2024年第7期1231-1239,共9页China Pharmacist

基　　金：武汉市卫生健康委员会中医药科研项目(S202204210071)。

摘　　要：目的挖掘哌拉西林他唑巴坦(TZP)的药品不良事件(ADE)信号,促进临床合理、安全用药。方法采用比例失衡法对美国食品药品管理局不良事件报告系统(FAERS)自建库至2024年3月所有TZP ADE报告进行信号挖掘,分析报告病例的基本情况及不良反应相关信息。结果共提取得到主要怀疑药物涉及ADE报告数为20620513条,TZP为主要怀疑药物涉及ADE报告数为6489条。共挖掘ADE信号543个,涉及25个器官/系统分类(SOC),二次筛选最终检测出ADE信号数43个,其中新的ADE信号17个,ADE信号涉及SOC分类的数量排名前5为分别是皮肤及皮下组织类疾病、全身性疾病及给药部位各种反应、各类检查、感染及侵染类疾病、血液及淋巴系统疾病;ADE信号数排名前5位的首选术语分别为皮疹、发热、急性肾损伤、瘙痒、血小板减少症。青霉素类药物在血液及淋巴系统疾病存在多种不良反应信号,TZP导致血小板减少病例数最多,苯唑西林导致粒细胞缺乏关联强度比例报告比值比最高;TZP导致白细胞减少疗程中位数为11.00 d,累积剂量中位数为148.50 g;该药导致粒细胞缺乏疗程中位数为14.00 d,累积剂量中位数为216.00 g;该药导致血小板减少症疗程中位数为7.00d,累积剂量中位数为87.00 g。结论用药期间需密切关注皮肤及皮下组织类疾病相关不良反应,可能较胃肠道系统疾病更多;临床大剂量或长疗程应用TZP时可导致多个系统发生不良反应,尤其需密切关注血液及淋巴系统疾病相关不良反应,避免发生严重不良反应。Objective To explore the adverse drug event signal of piperacillintazobactam(TZP)and promote rational and safe use of drugs in clinic.Methods The proportional unbalance method was used to mine the signals of all TZP adverse events(ADE)reports from the inception of FDA adverse event reporting system(FAERS)to March 2024.The basic situation of the the reported cases and the relevant information of adverse reactions were analyzed.Results A total of 20620513 ADE reports were obtained for the main suspected drugs,and 6489 ADE reports were reported for TZP as the main suspected drug.543 ADE signals were mined,involving 25 system organ classifications(SOC).43 ADE signals were detected by secondary screening,and 17 ADE signals were new ADR signals.The top 5 ADE signals involved in SOC classification were skin and subcutaneous tissue disorders,general disorders and administration site reactions,various examinations,infections and infectious disease,and blood and lymphatic system disorders.The top 5 preferred terms for ADE signal number were rash,pyrexia,acute kidney injury,pruritus and thrombocytopenia.Penicillins had several ADE signals on blood and lymphatic system diseases.TZP led to thrombocytopenia with the largest number of cases,and oxacillin led to agranulocytosis with the highest proportional reporting ratio.The median treatment course of TZP induced leukopenia was 11.00 days,and the median accumulated dose was 148.50 g.The median treatment course of TZP induced agranulocytosis was 14.00 days,and the median accumulated dose was 216.00 g.The median treatment course of TZP induced thrombocytopenia was 7.00 days,and the median accumulated dose was 87.00 g.Conclusion The adverse reactions related to skin and subcutaneous tissue diseases should be paid close attention to during medication,which may be more common than those of gastrointestinal diseases.When large doses or long courses of TZP are clinically used,close attention should be paid to the adverse reactions related to blood and lymphatic system disorders to av

关 键 词：哌拉西林他唑巴坦 药物不良事件 FAERS数据库 信号挖掘 血液及淋巴系统疾病 用药安全 

分 类 号：R978[医药卫生—药品]