达帕格利弗洛辛在非活性狼性炎中的有效性和安全性:一个随机交叉试验
Gisele Vajgel1, Braziliano Miguel da Silva Júnior2, Carlos R Silva Miranda Filho3
1Nephrology department, Hospital das Clínicas, EBSERH Federal University of Pernambuco (UFPE), Recife, Brazil.
达帕格利弗洛辛在不活跃狼性炎 (LN) 患者中显著降低了蛋白尿. 这种SGLT2抑制剂显示出良好的安全性,为这一群体提供了新的治疗选择.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 接受免疫抑制治疗的狼性炎 (LN) 患者被排除在SGLT2抑制剂试验之外.
- 剩余蛋白尿是常见的不活跃的LN尽管标准的护理.
研究的目的:
- 评估达帕格利弗洛辛在不活跃的LN患者的疗效和安全性,这些患者有残留蛋白尿.
- 评估达帕格利弗洛辛对蛋白尿减少和特定LN队列的安全性的影响.
主要方法:
- 成年LN患者 (III类,IV±V类) 蛋白尿 >500毫克/24小时和稳定治疗的eGFR ≥20毫升/分钟被随机分类.
- 患者接受了达帕格利弗洛辛加标准护理 (SoC) 或单独SoC,六个月后进行交叉治疗.
- 主要终点是与基线相比,在6个月和12个月减少蛋白尿.
主要成果:
- 达帕格利弗洛辛治疗导致蛋白尿显著减少-36.1%,而仅使用SoC治疗则降低-3.5% (P=0.03).
- 低血压在达帕格利弗洛辛组更频繁 (33.3%),但没有出现药物戒断.
- 两组之间没有观察到血压或体重的显著变化;尿路感染很少见.
结论:
- 达帕格利弗洛辛在不活跃的狼性炎患者中显著减少残留蛋白尿.
- 该疗法表现出良好的安全性,这表明它是治疗该群体残留蛋白尿症的可行选择.
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