基于FAERS数据库的司美格鲁肽药品不良事件信号挖掘.pdfVIP

•药物与临床• 基于FAERS数据库的司美格鲁肽药品不良事件信号挖掘a 卢伟聲，何家汝,陈文埶南方医科大学第三附属医院药学部 ，广州510630) 中图分类号R977.1；R969.3 文献标志码A 文章编号1001-0408(2022)15-1865-06 DOI 10.6039yj.issn.1001-0408.2022.15.14 摘 要 目的挖掘司美格鲁肽的药品不良事件(ADE)信号，为临床合理用药提供依据 。方法采用比例失衡法对美国FDA不良 事件报告系统(FAERS) 自建库起至2021年9月所有的司美格鲁肽ADE报告进行信号挖掘 。分析报告病例的基本情况;映射得到 对应的系统器官分类(SOC),并与药品说明书记录的不良反应进行对比；对不同适应证患者的首选语(PT)进行分析 。结果共提 取到6 661例司美格鲁肽ADE报告,挖掘到194个有效信号 。6 661例ADE报告中男性 (43.40%)所占比例低于女性 (52.65%)；年 龄主要分布于＞40〜65岁(29.00%)和＞65岁(22.61%)；上报国家以美国为主 (83.88%)；报告年份主要集中在2021年(40.88%), 并呈逐年递增趋势；结局以严重ADE报告中的住院或住院时间延长 (17.78%)为主 。司美格鲁肽ADE信号映射到主SOC上主要 为胃肠系统疾病，各类损伤 、中毒和操作并发症，代谢与营养类疾病，各类检查 。以报告优势比＞10或ADE报告例数＞50例进行筛 选，在药話说明书的基础上增添了 48个新的潜在不良反应 。在报告例数排在前2位的适应证(即2型糖尿病和肥胖、超重、体质量 控制)中 ，以恶心、呕吐、腹泻为代表的胃肠系统相关ADE报告频次均较高，与药晶说明书相似 。结论本研究在司美格鲁肽药晶说 明书的基础上补充了 48个新的潜在不良反应 ,目前可认为司美格鲁肽的安全性较好。 关键词 司美格鲁肽;FDA不良事件报告系统;药晶不良事件;信号挖掘 ；比例失衡法 Adverse drug event signal mining of semaglutide based on FDA Adverse Event Reporting System database LU Weitao, HE Jiaru, CHEN Wenying (Dept, of Pharmacy, the Third Affiliated Hospital of Southern Medical University, Guangzhou 510630, China) ABSTRACT OBJECTIVE To excavate the adverse drug event (ADE) signals of semaglutide and provide reference for its clinical rational use. METHODS The proportional unbalance method was used to mine the signals of all semaglutide ADE reports from FDA Adverse Event Reporting System (FAERS) up to September 2021. The basic situations of the reported cases were analyzed. The corresponding system organ classification (SOC) was mapped and compared with the adverse drug reactions recorded in the drug instructions. Preferred terms (PT)of patients with different indications were analyzed. RESULTS A total of 6 661 semaglutide ADE reports were extracted and 194 valid signals were mined. Among 6 661 cases of ADE, the proportion of men (43.40% ) was lower than women (52.65%); the age was mainly distributed in 40-65 years old(29.00%) and 65 years old (22