基于FAERS数据库的泊沙康唑不良事件信号挖掘与分析  

Signal mining and analysis of posaconazole adverse events based on FAERS database

作　　者：屠莹[1] 陈丽娟[1] 钱红玉[2] 张思培 张瑶[1] 陈雪茁 TU Ying;CHEN Li-juan;QIAN Hong-yu;ZHANG Si-pei;ZHANG Yao;CHEN Xue-zhuo(Department of Pharmacy,Tianjin Chest Hospital,Tianjin 300222,China;Department of Respiratory and Critical Care Medicine,Tianjin Chest Hospital,Tianjin 300222,China)

机构地区：[1]天津市胸科医院药剂科,天津300222 [2]天津市胸科医院呼吸与危重症医学科,天津300222

出　　处：《现代药物与临床》2023年第11期2861-2866,共6页Drugs & Clinic

基　　金：天津市卫生健康委青年人才项目(TJWJ2021QN057);天津市医学重点学科(专科)建设项目(TJYXZDXK-049A)。

摘　　要：目的 分析探究泊沙康唑的不良事件(ADE)信号,为临床合理用药提供数据支持。方法 利用美国食品药品监督管理局不良事件呈报系统(FAERS)进行数据挖掘,分别应用报告比值比法(ROR)和比例报告比值比法(PRR)对泊沙康唑的不良事件信号进行分析研究。结果 泊沙康唑ADE多见于各类检查、肝胆系统、内分泌系统、胃肠系统。发现胰腺炎,麻痹性肠梗阻等ADE在该药品说明书中未见阐述。分别筛选出血药浓度变化、假性醛固酮增多症、胰腺炎、肝脏及心脏相关不良事件发生的危险因素。结论 应用该药前应详细评估患者的危险因素,并针对性进行相应不良事件的重点监测。Objective To analyze the adverse event signal of posaconazole to provide data support for clinical rational drug use. Methods The adverse event signal of posaconazole was analyzed by ROR and PRR using data mining of the FAERS. Results Posaconazole ADE is more common in various examinations, hepatobiliary system, endocrine system, gastrointestinal system. It was found that ADE such as pancreatitis and paralytic intestinal obstruction were not described in the drug instructions. The risk factors of hemorrhagic drug concentration change, pseudoaldosteronism, pancreatitis, liver and heart related adverse events were screened. Conclusion Before the use of this drug, the risk factors of patients should be evaluated in detail, and the corresponding adverse events should be monitored.

关 键 词：泊沙康唑 比例失衡法 不良事件 数据挖掘 血药浓度变化 假性醛固酮增多症 胰腺炎 

分 类 号：R978.1[医药卫生—药品]