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用于急性器官功能障碍患者的达帕格利弗洛辛:DEFENDER随机临床试验
Caio A M Tavares1,2, Luciano C P Azevedo1, Álvaro Rea-Neto3,4,5
1Hospital Israelita Albert Einstein, São Paulo, São Paulo, Brazil.
JAMA
|June 14, 2024
概括
像达帕格利弗洛辛这样的-葡萄糖共传递剂2 (SGLT-2) 抑制剂没有改善关键性疾病患者的治疗结果. 需要进一步的研究,因为信任区间很宽,不排除潜在的益处或危害.
科学领域:
- 危急护理医学
- 肝脏病学
- 心脏病学
- 内分泌学
背景情况:
- -葡萄糖携带体2 (SGLT-2) 抑制剂已被确立为2型糖尿病,心力衰竭和慢性病的治疗方法.
- 在急性器官功能障碍的危急患者中,SGLT-2 抑制剂的疗效仍未确定.
研究的目的:
- 评估SGLT-2抑制剂达帕格利弗洛辛对急性器官功能障碍的临床结果的影响.
- 评估标准重症监护室 (ICU) 治疗加上达帕格利弗洛辛是否能改善患者的治疗结果.
主要方法:
- 一个多中心,随机的,开放的临床试验,涉及507名患有至少一个器官功能障碍 (呼吸,心血管或脏) 的重症患者.
- 参与者接受了10毫克的达帕格利弗洛辛加上标准ICU护理或标准ICU护理,长达14天或直到退院.
- 主要结局是医院死亡率,置换治疗的开始和ICU停留时间的等级组合,使用赢比方法进行分析.
主要成果:
- 添加达帕格利弗洛辛并没有显著改善初级复合结果,其胜率为1. 01 (95% CI,0. 90-1. 13;P=. 89).
- 二次分析显示,在使用替代疗法时,达帕格利弗洛辛的益处概率更高 (10. 9% vs 15. 1%).
- 主要结果的置信区间很宽,因此无法得出关于潜在益处或危害的最终结论.
结论:
- 达帕格利弗洛辛在标准治疗中添加时,并没有显著改善急性器官功能障碍的重症患者的临床结果.
- 广泛的置信区间表明,对达帕格利弗洛辛在该群体中的真实效果存在不确定性.
- 需要进一步研究以澄清SGLT-2抑制剂在重症监护机构中的作用和安全性.
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