使用FAERS数据库对SGLT-2抑制剂和糖尿病足部感染之间的关联进行药监分析:一项观察性研究
Siqi Jia1, Qingping Zeng2, Ping Zhu1
1Department of Cardiology, Southwest Hospital, Army Medical University, Chongqing 400038, China.
Diabetes research and clinical practice
|January 23, 2026
概括
卡纳格利弗洛辛与其他SGLT-2抑制剂不同,它与糖尿病足感染 (DFI) 有着强烈的联系. 由于这种风险,接受canagliflozin的患者需要加强脚部监测.
科学领域:
- 药物监督 药物监督 药物监督
- 糖尿病管理 糖尿病管理
- 预防心血管疾病 预防心血管疾病
背景情况:
- -葡萄糖共运输体-2 (SGLT-2) 抑制剂对于管理2型糖尿病 (T2DM) 和心力衰竭 (HF) 至关重要.
- 虽然在减少心血管事件方面有效,但对于SGLT-2抑制剂可能导致糖尿病足部感染 (DFI) 的可能性存在担忧.
研究的目的:
- 通过使用现实世界药监数据,调查特定SGLT-2抑制剂与DFI风险之间的关联.
- 量化与不同SGLT-2抑制剂相关的DFI风险信号.
主要方法:
- 从2004年第一季度到2024年第二季度对FDA不良事件报告系统 (FAERS) 数据库的分析.
- 使用标准化监管活动医学词典 (MedDRA) 查询识别DFI案件.
- 使用报告几率比率 (ROR),比例报告比率 (PRR),信息组件 (IC) 和实证贝叶斯几何平均值 (EBGM) 进行不成比例分析,用于"首要疑似"药物事件.
主要成果:
- 在8,312,293份报告中,共有565起DFI病例与SGLT-2抑制剂有关.
- 卡纳格利弗洛辛表现出最高的DFI信号 (ROR 162.84),而恩帕格利弗洛辛和达帕格利弗洛辛没有显示出显著的关联.
- 随着较长时间的SGLT-2抑制剂暴露,观察到与时间相关的DFI风险增加,ROR在365天后显著升级.
结论:
- 卡纳格利弗洛辛与糖尿病足部感染 (DFI) 的风险增加密切相关.
- 临床医生应加强对使用SGLT-2抑制剂,特别是canagliflozin的患者的足部监测.
- 对高风险患者来说,考虑替代SGLT-2抑制剂可能是合理的,以减轻DFI风险.
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