基于FAERS数据库的司美格鲁肽药品不良事件信号挖掘

Adverse drug event signal mining of semaglutide based on FDA Adverse Event Reporting System database

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6661例司美格鲁肽ADE报告,挖掘到194个有效信号。6661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,在药品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,与药品说明书相似。结论本研究在司美格鲁肽药品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。

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 6661 semaglutide ADE reports were extracted and 194 valid signals were mined.Among 6661 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(22.61%);the reporting country was mainly the United States(83.88%);the report year was mainly concentrated in 2021(40.88%),with an increasing trend year by year;the main outcome was hospitalization or prolonged hospitalization in serious ADE reports(17.78%).Semaglutide ADE signal was mapped to the main SOC,mainly including gastrointestinal diseases,various injuries,poisoning and operation complications,metabolic and nutritional diseases,various examinations.The screening criteria were based on the report odds ratio>10 or ADE reported cases>50,and 48 new potential adverse drug reactions were added to the drug description.Among the indications with the top two reported cases(type 2 diabetes and obesity,overweight,weight control),the frequency of gastrointestinal system related ADE reports represented by nausea,vomiting and diarrhea was higher,which was similar to the drug instructions.CONCLUSIONS This study supplemented 48 new potential adverse drug reactions based on the drug instructions of semaglutide.At present,it can be considered that semaglutide is safe.