2型糖尿病新用户报告的SGLT2i的不良药物反应:积极监测研究
Camelia Bucșa1, Ioana Frenț1, Ramona Stefan2
1Pharmacovigilance Research Center, Faculty of Pharmacy, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania.
Pharmaceuticals (Basel, Switzerland)
|June 27, 2025
概括
这项研究追踪了患者报告的不良药物反应 (ADRs) 在新使用的-葡萄糖共运输体2抑制剂 (SGLT2i) 治疗2型糖尿病的患者中. 大多数不良反应是预期的,对于SGLT2i没有发现新的安全问题.
科学领域:
- 药物监督 药物监督 药物监督
- 内分泌学 在内分泌学.
- 临床药房 临床药房
背景情况:
- 患者的观点对于更新药物安全性概况至关重要.
- -葡萄糖共载体2抑制剂 (SGLT2i) 越来越多地用于2型糖尿病 (T2D).
- 在现实环境中了解患者报告的不良药物反应 (ADR) 是必不可少的.
研究的目的:
- 在罗马尼亚,针对T2D的SGLT2i新用户中,对患者报告的不良反应进行前性表征.
- 从患者的角度评估这些不良反应的因果关系和严重程度.
主要方法:
- 在12个月内对64名T2D患者进行了潜在的电话采访.
- 标准化表格捕获了患者病史,自制药和与SGLT2i相关的疑似ADR.
- 对ADR频率,类型,严重程度和因果关系的分析.
主要成果:
- 64名患者报告了73例疑似不良反应,平均为每名患者2.35例不良反应.
- 最常见的不良反应包括波拉基乌里亚, vulvovaginal 候选症,失尿症和低血糖症.
- 发现了三种严重的不良反应,但有混因素;没有发现新的安全问题.
结论:
- 患者报告的SGLT2i对T2D患者的不良反应在很大程度上与已确定的安全性概况保持一致.
- 在这项罗马尼亚观察研究中,没有发现新的安全问题.
- 患者报告的结果为持续的药物安全监测提供了有价值的数据.
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