基于FAERS的老年患者应用钠-葡萄糖协同转运蛋白-2抑制剂严重不良事件分析  

Analysis of serious adverse drug events in elderly patients using sodium-glucose cotransporter-2 inhibitor based on FAERS

作　　者：于海雁[1] 苏文凌[1] YU Hai-yan;SU Wen-ling(Department of Endocrinology,Tianjin Chest Hospital,Tianjin 300070,China)

机构地区：[1]天津市胸科医院内分泌科,天津300070

出　　处：《中国新药杂志》2024年第20期2185-2192,共8页Chinese Journal of New Drugs

基　　金：天津市卫生健康委科技项目(RK20012)。

摘　　要：目的:分析老年患者应用钠-葡萄糖协同转运蛋白-2抑制剂(sodium-glucose cotransporter-2 inhibitor,SGLT-2i)的严重不良事件,为老年患者安全用药提供参考。方法:对美国FDA不良事件报告系统(FDA Adverse Event Reporting System,FAERS)数据库中记载的以SGLT-2i为首要怀疑药物的不良事件报告进行挖掘,并使用卡方检验分析老年患者与非老年患者严重药品不良事件(adverse drug event,ADE)发生率和结局的差异。结果:本研究共提取年龄记录清晰报告25416份,其中老年患者报告10605份,除恩格列净致老年患者急性肾损伤信号为阴性外,其余均为阳性信号;使用卡格列净的老年患者发生严重ADE的概率显著低于非老年患者;老年患者因严重ADE致死亡或威胁生命结局综合概率方面,恩格列净>达格列净>卡格列净。结论:老年患者应用卡格列净致4种严重ADE的发生率和致死亡或威胁生命结局的综合概率最低,而恩格列净最高。建议临床加强对老年患者应用SGLT-2i不良反应情况的深入研究,为指导安全用药提供参考。Objective:To analyze the serious adverse drug events of sodium-glucose cotransporter-2 inhibitors(SGLT-2i)in elderly patients thus to provide reference for safe medication in elderly patients.Methods:The adverse drug event reports of SGLT-2i as first suspected drugs recorded in the FAERS database were mined,and chi-square test was used to analyze the differences in the incidence and outcome between elderly and non-elderly patients.Results:A total of 25416 reports with clear age records were extracted in this study,of which 10605 reports were from elderly patients.Except for the negative signal of acute kidney injury caused by empagliflozin in elderly patients,all other signals were positive.The probability of serious ADE occurring in elderly patients using canagliflozin was significantly lower than that in non-elderly patients.In terms of the probability of death or life-threatening outcomes in elderly patients due to serious ADE,empagliflozin>dapagliflozin>canagliflozin.Conclusion:The incidences of four serious ADE and the probability of death or life-threatening outcomes caused by canagliflozin in elderly patients are the lowest,while those for empagliflozin are the highest.It is recommended to conduct in-depth research on the adverse drug reactions of SGLT-2i in elderly patients in clinical practice,in order to provide reference for safe medication.

关 键 词：美国FDA不良事件报告系统 老年患者 钠-葡萄糖协同转运蛋白-2抑制剂 严重不良事件 

分 类 号：R969.3[医药卫生—药理学]