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评估加用达格列净治疗急性失代偿性心力衰竭时肾功能恶化情况的随机试验

Randomized trial to assess worsening renal function by adding dapagliflozin for acute decompensated heart failure.

作者信息

Kawanami Shodai, Egami Yasuyuki, Abe Masaru, Osuga Mizuki, Nohara Hiroaki, Ukita Kohei, Kawamura Akito, Yasumoto Koji, Okamoto Naotaka, Matsunaga-Lee Yasuharu, Yano Masamichi, Nishino Masami

机构信息

Division of Cardiology, Osaka Rosai Hospital, Osaka, Japan.

出版信息

ESC Heart Fail. 2025 Jun;12(3):2023-2033. doi: 10.1002/ehf2.15212. Epub 2025 Jan 31.

Abstract

AIMS

Dapagliflozin (DAPA), a sodium-glucose co-transporter 2 inhibitor, has been shown to reduce cardiovascular mortality among patients with chronic heart failure. We aimed to evaluate the impact on a worsening renal function (WRF) by adding DAPA as compared to standard decongestive therapy with loop diuretics alone.

METHODS AND RESULTS

We enrolled 114 consecutive acute decompensated heart failure (ADHF) patients with a left ventricular ejection fraction (LVEF) of less than 50%. The patients were prospectively randomized to be assigned either to DAPA group who received DAPA at a dose of 10 mg once daily within 24 h after admission or conventional therapy group (CON group) who received loop diuretics alone. All patients were adjusted by increasing or decreasing the loop diuretic by 10 mg to maintain a 1-2 mL/kg/h urine output. The primary endpoint was the incidence of WRF, which was defined as an increase in the serum creatinine of ≥0.3 mg/dL from baseline. The median age of the patients was 77 [interquartile range (IQR): 64, 85] years, 35% were female and the median LVEF was 33 [IQR: 28, 38] %. There was no significant difference in the incidence of WRF between the two groups (16.1%, n = 9 vs. 12.1%, n = 7, P value = 0.54). The total dose of loop diuretics through day 7 was lower in the DAPA group than CON group (184 ± 79.5 mg vs. 214 ± 66.5 mg, P value = 0.03).

CONCLUSIONS

This randomized prospective trial revealed the addition of DAPA within 24 h after admission reduced the diuretic dose without WRF.

摘要

目的

达格列净(DAPA)是一种钠-葡萄糖协同转运蛋白2抑制剂,已被证明可降低慢性心力衰竭患者的心血管死亡率。我们旨在评估与单独使用襻利尿剂的标准消肿治疗相比,加用DAPA对肾功能恶化(WRF)的影响。

方法和结果

我们纳入了114例连续的急性失代偿性心力衰竭(ADHF)患者,其左心室射血分数(LVEF)小于50%。患者被前瞻性随机分为DAPA组,在入院后24小时内接受每日一次10毫克剂量的DAPA治疗,或传统治疗组(CON组),仅接受襻利尿剂治疗。所有患者通过增加或减少10毫克襻利尿剂进行调整,以维持1-2毫升/千克/小时的尿量。主要终点是WRF的发生率,定义为血清肌酐较基线水平升高≥0.3毫克/分升。患者的中位年龄为77岁[四分位间距(IQR):64,85],35%为女性,中位LVEF为33%[IQR:28,38]。两组之间WRF的发生率没有显著差异(16.1%,n = 9 vs. 12.1%,n = 7,P值 = 0.54)。DAPA组至第7天的襻利尿剂总剂量低于CON组(184±79.5毫克 vs. 214±66.5毫克,P值 = 0.03)。

结论

这项随机前瞻性试验表明,入院后24小时内加用DAPA可降低利尿剂剂量且不会导致WRF。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e20/12055397/6cace7d267a9/EHF2-12-2023-g003.jpg

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