基于美国FAERS数据库的舒尼替尼相关药品不良事件信号挖掘与分析  

Mining and Analysis of Sunitinib-Related Adverse Drug Events Signals Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database

作　　者：高媛 张之晗 王晓倩 高美龄 李从欣 GAO Yuan;ZHANG Zhihan;WANG Xiaoqian;GAO Meiling;LI Congxin(Dept.of Pharmacy,Hebei Medical University Third Hospital,Shijiazhuang 050051,China;Dept.of Clinical Nutrition,the Fourth Hospital of Hebei Medical University,Shijiazhuang 050011,China)

机构地区：[1]河北医科大学第三医院药剂科,石家庄050051 [2]河北医科大学第四医院临床营养科,石家庄050011

出　　处：《中国医院用药评价与分析》2025年第1期93-97,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家自然科学基金资助项目(No.82003878);河北省自然科学基金资助项目(No.H2024206062);河北省医学科学研究课题计划资助(No.20240157)。

摘　　要：目的:挖掘并分析舒尼替尼相关药品不良事件(ADE)信号,为临床安全使用舒尼替尼提供参考。方法:收集美国食品药品监督管理局不良事件报告系统数据库中2006年第1季度至2023年第4季度共72个季度的舒尼替尼相关ADE数据,利用比例失衡法中的报告比值比法及比例报告比值比法进行数据挖掘与分析。结果:共获得舒尼替尼相关ADE报告35898份,患者的中位年龄为65岁;以男性患者为主(21314份,占59.37%);上报国家以美国为主(13057份,占36.37%);严重ADE结局多为死亡(10778份,占30.02%)或住院治疗(10356份,占28.85%)。共检测到ADE风险信号284个,涉及20个系统器官分类,主要为全身性疾病及给药部位各种反应、胃肠系统疾病。发生例次数较多的ADE信号与舒尼替尼药品说明书中的记载基本一致,如食欲减退、高血压、血液学毒性、掌跖红肿综合征。需临床重点关注的、新的ADE信号主要为死亡、心肺衰竭、进展性肿瘤、脱水、胸腔积液、腹水等。结论:临床使用舒尼替尼前应做好患者的用药评估,治疗期间应警惕包括心脏不良事件在内的其他致死性ADE的发生,发现异常时应及时干预。OBJECTIVE:To mine and analyze the sunitinib-related adverse drug events(ADE)signals,so as to provide reference for clinical safe use of sunitinib.METHODS:Sunitinib-related ADE data were collected from the U.S.Food and Drug Administration Adverse Event Reporting System database for 72 quarters from the first quarter of 2006 to the fourth quarter of 2023.The reporting odds ratio method and the proportional reporting ratio method of proportional imbalance measurement were used for data mining and analysis.RESULTS:A total of 35898 sunitinib-related ADE reports were obtained,with patients’median age of 65 years.Male patients were the most(21314 reports,59.37%).Most of the reported cases were from the United States(13057 reports,36.37%),and most of the severe ADE cases were death(10778 reports,30.02%)or hospitalization(10356 reports,28.85%).A total of 284 ADE risk signals were detected,including 20 system organ classification,mainly for systemic disorders,drug administration site reactions,and gastrointestinal diseases.ADE signals with a high number of occurrence were generally consistent with those in the drug instructions of sunitinib,such as loss of appetite,hypertension,haematological toxicity,and hand-foot skin reaction.The new ADE signals that need clinical attention were death,heart and lung failure,progressive tumor,dehydration,pleural effusion,and ascites.CONCLUSIONS:Patients should be evaluated before using sunitinib.The occurrence of fatal ADE,including adverse cardiac events,should be considered during treatment and timely intervented when abnormalities are found.

关 键 词：舒尼替尼 美国食品药品监督管理局不良事件报告系统数据库 药品不良事件 信号挖掘 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]