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Efficacy and Safety of 1-Hour Infusion of Recombinant Human Atrial Natriuretic Peptide in Patients With Acute Decompensated Heart Failure A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial  期刊论文  

  • 编号:
    0a095e4c-0cf1-47ee-b83e-31ac2885b912
  • 作者:
  • 语种:
    英文
  • 期刊:
    MEDICINE ISSN:0025-7974 2016 年 95 卷 9 期 ; MAR
  • 收录:
  • 摘要:

    The aim of the study was to evaluate the efficacy and safety of 1-h infusion of recombinant human atrial natriuretic peptide (rhANP) in combination with standard therapy in patients with acute decompensated heart failure (ADHF).
    This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Eligible patients with ADHF were randomized to receive a 1-h infusion of either rhANP or placebo at a ratio of 3: 1 in combination with standard therapy. The primary endpoint was dyspnea improvement (a decrease of at least 2 grades of dyspnea severity at 12 h from baseline). Reduction in pulmonary capillary wedge pressure (PCWP) 1 h after infusion was the co-primary endpoint for catheterized patients. Overall, 477 patients were randomized: 358 (93 catheterized) patients received rhANP and 118 (28 catheterized) received placebo. The percentage of patients with dyspnea improvement at 12 h was higher, although not statistically significant, in the rhANPgroup than in the placebo group (32.0% vs 25.4%, odds ratio = 1.382, 95% confidence interval [CI]: 0.863-2.212, P = 0.17). Reduction in PCWP at 1 h was significantly greater in patients treated with rhANP than in patients treated with placebo (-7.74 +/- 5.95 vs -1.82 +/- 4.47 mm Hg, P< 0.001). The frequencies of adverse events and renal impairment within 3 days of treatment were similar between the 2 groups. Mortality at 1 month was 3.1% in the rhANP group vs 2.5% in the placebo group (hazard ratio = 1.21, 95% CI: 0.34-4.26; P>0.99).
    1-h rhANP infusion appears to result in prompt, transient hemodynamic improvement with a small, nonsignificant, effect on dyspnea in ADHF patients receiving standard therapy. The safety of 1-h infusion of rhANP seems to be acceptable.

  • 推荐引用方式
    GB/T 7714:
    Wang Guogan,Wang Pengbo,Li Yishi, et al. Efficacy and Safety of 1-Hour Infusion of Recombinant Human Atrial Natriuretic Peptide in Patients With Acute Decompensated Heart Failure A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial [J].MEDICINE,2016,95(9).
  • APA:
    Wang Guogan,Wang Pengbo,Li Yishi,Liu Wenxian,&Wang Sijia.(2016).Efficacy and Safety of 1-Hour Infusion of Recombinant Human Atrial Natriuretic Peptide in Patients With Acute Decompensated Heart Failure A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial .MEDICINE,95(9).
  • MLA:
    Wang Guogan, et al. "Efficacy and Safety of 1-Hour Infusion of Recombinant Human Atrial Natriuretic Peptide in Patients With Acute Decompensated Heart Failure A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial" .MEDICINE 95,9(2016).
  • 入库时间:
    12/4/2019 7:14:58 PM
  • 更新时间:
    12/4/2019 7:14:58 PM
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