Duke University School of Medicine and Duke Heart Center, Durham, NC, USA.
N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419.
Loop diuretics are an essential component of therapy for patients with acute decompensated heart failure, but there are few prospective data to guide their use.
In a prospective, double-blind, randomized trial, we assigned 308 patients with acute decompensated heart failure to receive furosemide administered intravenously by means of either a bolus every 12 hours or continuous infusion and at either a low dose (equivalent to the patient's previous oral dose) or a high dose (2.5 times the previous oral dose). The protocol allowed specified dose adjustments after 48 hours. The coprimary end points were patients' global assessment of symptoms, quantified as the area under the curve (AUC) of the score on a visual-analogue scale over the course of 72 hours, and the change in the serum creatinine level from baseline to 72 hours.
In the comparison of bolus with continuous infusion, there was no significant difference in patients' global assessment of symptoms (mean AUC, 4236±1440 and 4373±1404, respectively; P=0.47) or in the mean change in the creatinine level (0.05±0.3 mg per deciliter [4.4±26.5 μmol per liter] and 0.07±0.3 mg per deciliter [6.2±26.5 μmol per liter], respectively; P=0.45). In the comparison of the high-dose strategy with the low-dose strategy, there was a nonsignificant trend toward greater improvement in patients' global assessment of symptoms in the high-dose group (mean AUC, 4430±1401 vs. 4171±1436; P=0.06). There was no significant difference between these groups in the mean change in the creatinine level (0.08±0.3 mg per deciliter [7.1±26.5 μmol per liter] with the high-dose strategy and 0.04±0.3 mg per deciliter [3.5±26.5 μmol per liter] with the low-dose strategy, P=0.21). The high-dose strategy was associated with greater diuresis and more favorable outcomes in some secondary measures but also with transient worsening of renal function.
Among patients with acute decompensated heart failure, there were no significant differences in patients' global assessment of symptoms or in the change in renal function when diuretic therapy was administered by bolus as compared with continuous infusion or at a high dose as compared with a low dose. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00577135.).
在治疗急性失代偿性心力衰竭患者时,袢利尿剂是治疗的重要组成部分,但几乎没有前瞻性数据来指导其使用。
在一项前瞻性、双盲、随机试验中,我们将 308 例急性失代偿性心力衰竭患者随机分为两组,分别接受静脉推注呋塞米或持续输注,推注每 12 小时一次,剂量为低剂量(相当于患者之前的口服剂量)或高剂量(2.5 倍之前的口服剂量)。方案允许在 48 小时后进行特定的剂量调整。主要终点是患者的整体症状评估,用视觉模拟量表评分的曲线下面积(AUC)来量化,评估时间为 72 小时;次要终点是血清肌酐水平从基线到 72 小时的变化。
与持续输注相比,推注与连续输注在患者的整体症状评估方面没有显著差异(平均 AUC 分别为 4236±1440 和 4373±1404,P=0.47),或血清肌酐水平的平均变化(分别为 0.05±0.3mg/每分升[4.4±26.5μmol/每升]和 0.07±0.3mg/每分升[6.2±26.5μmol/每升],P=0.45)。与低剂量策略相比,高剂量策略组患者的整体症状评估有改善的趋势,但无统计学意义(平均 AUC 分别为 4430±1401 和 4171±1436,P=0.06)。在肌酐水平的平均变化方面,两组间无显著差异(高剂量策略组为 0.08±0.3mg/每分升[7.1±26.5μmol/每升],低剂量策略组为 0.04±0.3mg/每分升[3.5±26.5μmol/每升],P=0.21)。高剂量策略与更大的利尿作用和一些次要指标的更有利结果相关,但也与肾功能的短暂恶化相关。
在急性失代偿性心力衰竭患者中,与连续输注或低剂量相比,静脉推注与持续输注或高剂量相比,在患者的整体症状评估或肾功能变化方面均无显著差异。(由美国国立心肺血液研究所资助;ClinicalTrials.gov 编号,NCT00577135。)