摘要
目的 基于美国食品药品监督管理局(FDA)不良反应事件报告系统(FAERS)数据库,分析司美格鲁肽的不良事件信号,为临床安全用药提供参考。方法 利用报告比值比法和比例报告比值法,分析FAERS数据库中2019年第1季度至2021年第3季度共11个季度关于司美格鲁肽的不良事件报告。结果 获得以司美格鲁肽为目标药物的不良事件的报告数11 113个,检测获得有效信号193个,共涉及23个系统器官分类,其中报告例次位于前3的为胃肠系统疾病(6480例,58.31%),各类检查(如血葡萄糖升高、糖化血红蛋白升高及血葡萄糖降低等)(1461例,13.15%),代谢及营养类疾病(1205例,10.84%)。结论 司美格鲁肽的药品不良事件(ADE)主要集中在胃肠系统、各类检查和代谢及营养类疾病,建议临床用药时应注意监测患者的不良反应,及时采取相应措施。
Objectives To analyze the adverse reaction signals of semaglutide based on the U.S.Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database,and to provide reference for clinical safe medication.Methods The reporting odds ratio method and the proportional reporting odds method were used,and 11 quarters of adverse events reports on semaglutide in the FAERS database (from the first quarter of 2019 to the third quarter of 2021) were analyzed.Results Totally 11 113 reports of adverse events with semaglutide as the target drug were collected,and 193 valid signals were detected,involving 23 systems organs classes.The top three reported cases included gastrointestinal systemic diseases 6480 cases (58.31%),various examinations (such as elevated blood glucose,elevated glycated hemoglobin and low blood glucose,etc.1461 cases (13.15%),and metabolic and nutritional diseases 1205 cases (10.84%).Conclusion Adverse events of semaglutide is mainly concentrated in the gastrointestinal system,various examinations,and metabolic and nutritional diseases.Patients should be monitored for adverse reactions during clinical medication,and corresponding measures should be taken in time.
作者
吴玥
陈力
何绪成
WU Yue;CHEN Li;HE Xu-cheng(Department of Pharmacy,West China Second Hospital,Sichuan University,Chengdu 610041;Department of Pharmacy,Second People's Hospital of Pengzhou,Pengzhou Sichuan 611934)
出处
《中南药学》
CAS
2022年第9期2160-2164,共5页
Central South Pharmacy
基金
国家自然科学基金项目(No.82073921)。
关键词
司美格鲁肽
报告比值比法
比例失衡法
不良事件报告信号
semaglutide
reporting odds ratio method
proportional imbalance method
adverse events reporting signal
