基于FAERS数据库的胰高血糖素样肽-1受体激动剂药物不良信号的数据挖掘与分析

Data mining and analysis of adverse drug events signals of glucagon-like peptide-1 receptor agonists based on FAERS database

目的:利用美国FDA不良事件报告系统(FAERS)挖掘胰.高血糖素样肽-1受体激动剂(GLP-1 RAs)上市后的药品不良事件(ADE),为临床安全用药提供参考。方法:提取FAERS数据库2004年第一季度至2021年第三季度5种国内外均上市的GLP-1 RAs的不良反应报告数据,采用报告比值比法和比例报告比值法对相关报告进行数据挖掘。结果:共提取ADE报告138821份,其中艾塞那肽62023份、度拉糖肽39531份、利拉鲁肽29227份、司美格鲁肽6661份和利司那肽1379份。常见不良反应为胃肠道不良反应、注射部位皮肤或组织异常、神经系统异常、低血糖症状以及甲状腺C细胞肿瘤风险等。可能存在的新的风险信号包括注射部位外渗、胰腺癌、糖尿病酮症酸中毒和胆囊功能障碍。结论:通过FAERS数据挖掘分析,可发现药品已知和新的不良反应,从而提示临床加以关注,确保患者用药安全。

Objective:To mine the post-marketing adverse drug event(ADE)of glucagon-like peptide-1 receptor agonists(GLP-1 RAs)based on the FDA adverse event reporting system(FAERS)database in order to provide references for clinical safety drug use.Methods:Data of ADE associated with five GLP-1 RAs marketed at home and abroad from the first quarter of2004 to the third quarter of 2021 were extracted from FAERS database and were analyzed by the reporting odds ratio method and the proportional reporting ratio method.Results:A total of 138821 ADE reports were extracted including 62023 ADE reports of exenatide,39531 ADE reports of dulaglutide,29227 ADE reports of liraglutide,6661 ADE reports of semaglutide and 1379 ADE reports of lixisenatide.ADEs were mainly concentrated on gastrointestinal adverse reactions,abnormality in skin or tissue at injection site,nervous system abnormalities,hypoglycemia,risk of thyroid C cell tumors and so on.The potential new risk signals were exosmosis in injection site,pancreatic cancer,diabetic ketoacidosis and gallbladder dysfunction.Conclusion:The known and possible new adverse reactions of drugs can be found through the data mining analysis of FAERS,it is suggested that clinical attentions should be paid to ensure drug safety of patients.