基于FAERS数据库对瑞波西利不良事件的信号检测与分析  

Signal detection and analysis of adverse events of ribociclib based on FAERS database

作　　者：孙彩红 李文凤[3] 梁瑜[1] 李晓[1] 崔萌纳[1] 江凯[1] 全香花[1] SUN Cai-hong;LI Wen-feng;LIANG Yu;LI Xiao;CUI Meng-na;JIANG Kai;QUAN Xiang-hua(Department of Pharmacy,Affiliated Hospital of Qingdao University,Qingdao 266003,China;College of Pharmacy,Yanbian University,Yanji 133002,China;Breast Disease Therapy Center,Qingdao University Affiliated Hospital,Qingdao 266003,China)

机构地区：[1]青岛大学附属医院药学部,山东青岛266003 [2]延边大学药学院,吉林延吉133002 [3]青岛大学附属医院乳腺病诊疗中心,山东青岛266003

出　　处：《现代药物与临床》2023年第10期2600-2607,共8页Drugs & Clinic

基　　金：山东省医学会临床科研资金--齐鲁专项(YXH2022ZX02067)。

摘　　要：目的基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库对瑞波西利不良事件(ADE)进行分析,为临床安全用药提供参考。方法通过访问FAERS数据库,检索2017年3月13日—2023年3月31日瑞波西利的ADE的数据。采用报告比值比(ROR)法联合贝叶斯可信区间递进神经网络法(BCPNN)进行信号挖掘,分析ADE的发生情况。结果共获得371个ADE信号,涉及23个系统器官类别(SOC),收集报告30999份。主要上报国家是美国;涉及的SOC主要包括各类检查、血液及淋巴系统疾病、全身性疾病及给药部位各种反应、良性与恶性及性质不明的肿瘤、呼吸系统与胸及纵膈疾病等。最常报告的ADE信号包括中性粒细胞减少症、白细胞计数降低、脱发、食欲减退、便秘等。说明书未收录的ADE如大红细胞症、丹毒、日光性雀斑样痣、免疫功能降低等26个可疑信号需给予关注。结论瑞波西利在真实世界中常见的ADE与说明书一致,但也存在一些新的疑似ADE,临床用药时应予以重视。Objective To analyze the adverse events of ribociclib based on the adverse event(ADE)reporting system(FAERS)database of the united states food and drug administration,so as to provide reference for clinical safe use of drugs.Methods ADE in ribociclib from 13 March 2017 to 31 March 2023 were retrieved by accessing the FAERS database.The reported ratio ratio(ROR)method combined with Bayesian confidence interval progressive neural network(BCPNN)method was used for signal mining and the occurrence of ADE was analyzed.Results A total of 371 ADE signals were obtained involving 23 system organ classes(SOC),and 30999 reports were collected.The main reporting countries are the United States,SOC involved mainly includes various examinations,blood and lymphatic system diseases,systemic diseases and various reactions at the administration site,benign and malignant tumors with unknown nature,respiratory system and thoracic and mediastinal diseases,etc.The most frequently reported ADE signals include neutropenia,decreased white blood cell counts,alopecia,anorexia,constipation,and others.Twenty-six suspicious signals of ADE such as erythrocytosis,erysipelas,freckle-like nevus solaris,and decreased immune function that were not included in the manual should be paid attention.Conclusion The common adverse reactions of ribociclib in the real world were consistent with the instructions,but there were some new suspected adverse reactions,which should be paid attention to during clinical medication.

关 键 词：瑞波西利 FAERS数据库 药物不良事件 信号挖掘 大红细胞症 丹毒 日光性雀斑样痣 免疫功能降低 

分 类 号：R979.1[医药卫生—药品]