基于美国FAERS数据库的培唑帕尼不良事件信号挖掘与分析  

Signals mining and analysis of adverse drug events of pazopanib based on FAERS database

作　　者：薄明明 石亚飞 孙继雄 王天宇 李国辉 戴媛媛 BO Mingming;SHI Yafei;SUN Jixiong;WANG Tianyu;LI Guohui;DAI Yuanyuan(Dept.of Pharmacy,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Dept.of Pharmacy,Langfang Branch,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences,Hebei Langfang 065001,China;Information Management Center,Langfang Branch,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences,Hebei Langfang 065001,China)

机构地区：[1]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院药剂科,北京100021 [2]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院肿瘤医院廊坊院区药剂科,河北廊坊065001 [3]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院肿瘤医院廊坊院区信息管理中心,河北廊坊065001

出　　处：《中国药房》2023年第15期1879-1883,共5页China Pharmacy

基　　金：中国医学科学院肿瘤医院管理研究课题(No.LC2021D04)。

摘　　要：目的 挖掘并分析培唑帕尼上市后的药物不良事件(ADE)信号,为临床安全用药提供参考。方法 通过OpenVigil 2.1数据平台对美国FDA药物不良事件报告系统(FAERS)数据库进行信号挖掘,收集培唑帕尼2009年10月-2022年6月的ADE报告,采用比例失衡法中的比例报告比值(PRR)法和报告比值比(ROR)法检测该药的ADE信号并进行分析。结果 共筛选出以培唑帕尼为首要怀疑药物的ADE报告16 655份,经ROR法、PRR法挖掘出ADE信号220个,涉及19个系统器官分类。信号频度排前10位的ADE信号在该药的药品说明书中均有记载;发现了88个新的ADE信号,主要分布在胃肠系统、各种检查、肾脏和泌尿系统。嗜碱细胞数减少、甲床出血、肿瘤破裂、阴道瘘既是新的ADE信号,也是信号强度排前10位的ADE信号。结论 培唑帕尼在上市后应用中常见ADE(腹泻、毛发颜色改变、高血压等)的发生情况与其药品说明书基本一致;新的可疑风险信号(嗜碱细胞数减少、甲床出血、肿瘤破裂、阴道瘘等)报道例数较少,还需持续关注。OBJECTIVE To mine and analyze adverse drug event(ADE)signals after the marketing of pazopanib and provide references for clinically safe medication.METHODS OpenVigil 2.1 data platform was used to mine ADE signals from the US FDA adverse event reporting system(FAERS)database.ADE reports of pazopanib from October 2009 to June 2022 were collected,and ADE signals were analyzed using proportional reporting ratio(PRR)method and reporting odds ratio(ROR)method in the proportional imbalance method.RESULTS A total of 16655 ADE reports were identified with pazopanib as the primary suspect drug.Through ROR and PRR analysis,220 ADE signals involving 19 system organ classes were identified.The top 10 ADE signals by frequency were recorded in the drug instruction.Additionally,88 new ADE signals were discovered,mainly related to the gastrointestinal system,various investigations,and the renal and urinary system.Decreased basophil count,nail bed hemorrhage,tumor rupture,and vaginal fistula were both new ADE signals and the top 10 ADE signals by strength.CONCLUSIONS The occurrence of common ADEs(diarrhea,hair color changes,hypertension,etc.)during the use of pazopanib after marketing is generally consistent with its drug instruction;the number of reported cases for new suspected risk signals(decreased basophil count,nail bed hemorrhage,tumor rupture,and vaginal fistula,etc.)is limited,and continuous monitoring is required.

关 键 词：培唑帕尼 药物不良事件 信号挖掘 药物不良反应 比例失衡法 

分 类 号：R969.3[医药卫生—药理学]