在FAERS数据库 (2013-2024) 中报告的与-葡萄糖共运输体-2 (SGLT2) 抑制剂有关的严重不良事件:药监测研究研究 (2013-2024)
1Department of Pharmacology, College of Medicine, Imam Mohammad Ibn Saud Islamic University (IMSIU), Riyadh, Saudi Arabia. maahsan@imamu.edu.sa.
Naunyn-Schmiedeberg's archives of pharmacology
|December 1, 2025
概括
严重的不良事件 (SAE) 是常见的与-葡萄糖共载体2抑制剂 (SGLT2i) 治疗,住院和死亡是主要的结果. 特定的SGLT2i药物和患者年龄和性别等因素会影响SAE风险.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 药品安全 药品安全
背景情况:
- -葡萄糖共载体2抑制剂 (SGLT2i) 广泛用于2型糖尿病管理.
- 了解与严重不良事件 (SAE) 相关的报告趋势和因素对于患者安全至关重要.
研究的目的:
- 分析SGLT2i治疗后发生的SAE的报告趋势,特征和相关因素.
- 在FAERS数据库中检测SGLT2i的潜在药监信号.
主要方法:
- 来自FAERS数据库的标准化数据的描述性分析.
- 计算几率比率 (OR) 和置信区间 (CI) 以确定相关因素.
- 报告几率比率 (ROR),比例报告比率 (PRR) 和信息组件 (IC025) 的应用用于信号检测.
主要成果:
- 在SGLT2i报告中,SAE占45%,主要结果是住院和死亡.
- 达帕格利弗洛辛和恩帕格利弗洛辛占SAE报告的70%以上;卡纳格利弗洛辛与住院住院的相关性更高.
- 男性性别,65岁以上的年龄和卡纳格利弗洛辛的使用与SAE风险增加有关. 强烈的信号包括Fournier的热和euglycemic的糖尿病酸性脂肪酸症.
结论:
- 在FAERS数据库中,SAE占SGLT2i报告的很大一部分.
- 个别的SGLT2i药物表现出不同的SAE概况.
- 药监信号检测确定了与SGLT2i治疗相关的已知和意想不到的不良事件.
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