大剂量硝酸异山梨酯联合小剂量呋塞米与大剂量呋塞米联合小剂量硝酸异山梨酯治疗重度肺水肿的随机试验

Randomised trial of high-dose isosorbide dinitrate plus low-dose furosemide versus high-dose furosemide plus low-dose isosorbide dinitrate in severe pulmonary oedema.

作者信息

Cotter G, Metzkor E, Kaluski E, Faigenberg Z, Miller R, Simovitz A, Shaham O, Marghitay D, Koren M, Blatt A, Moshkovitz Y, Zaidenstein R, Golik A

机构信息

Assaf Harofeh Medical Center, Zerifin, Israel.

出版信息

Lancet. 1998 Feb 7;351(9100):389-93. doi: 10.1016/S0140-6736(97)08417-1.

DOI:10.1016/S0140-6736(97)08417-1

PMID:9482291

Abstract

BACKGROUND

Nitrates and furosemide, commonly administered in the treatment of pulmonary oedema, have not been compared in a prospective clinical trial. We compared the efficacy and safety of these drugs in a randomised trial of patients with severe pulmonary oedema and oxygen saturation below 90%.

METHODS

Patients presenting to mobile emergency units with signs of congestive heart failure were treated with oxygen 10 L/min, intravenous furosemide 40 mg, and morphine 3 mg bolus. 110 patients were randomly assigned either to group A, who received isosorbide dinitrate (3 mg bolus administered intravenously every 5 min; n=56) or to group B, who received furosemide (80 mg bolus administered intravenously every 15 min, as well as isosorbide dinitrate 1 mg/h, increased every 10 min by 1 mg/h; n=54). Six patients were withdrawn on the basis of chest radiography results. Treatment was continued until oxygen saturation was above 96% or mean arterial blood pressure had decreased by 30% or to below 90 mm Hg. The main endpoints were death, need for mechanical ventilation, and myocardial infarction. The analyses were by intention to treat.

FINDINGS

Mechanical ventilation was required in seven (13%) of 52 group-A patients and 21 (40%) of 52 group-B patients (p=0.0041). Myocardial infarction occurred in nine (17%) and 19 (37%) patients, respectively (p=0.047). One patient in group A and three in group B died (p=0.61). One or more of these endpoints occurred in 13 (25%) and 24 (46%) patients, respectively (p=0.041).

INTERPRETATION

High-dose isosorbide dinitrate, given as repeated intravenous boluses after low-dose intravenous furosemide, is safe and effective in controlling severe pulmonary oedema. This treatment regimen is more effective than high-dose furosemide with low-dose isosorbide nitrate in terms of need for mechanical ventilation and frequency of myocardial infarction.

摘要

背景

硝酸盐类药物和呋塞米常用于治疗肺水肿，但尚未在前瞻性临床试验中进行比较。我们在一项针对重度肺水肿且氧饱和度低于90%患者的随机试验中比较了这两种药物的疗效和安全性。

方法

出现充血性心力衰竭体征并前往移动急救单元就诊的患者接受10L/min的氧气治疗、静脉注射40mg呋塞米和3mg吗啡推注。110例患者被随机分为A组（56例），接受静脉注射硝酸异山梨酯（每5分钟静脉推注3mg；n=56）或B组（54例），接受呋塞米（每15分钟静脉推注80mg，以及硝酸异山梨酯1mg/h，每10分钟增加1mg/h；n=54）。6例患者根据胸部X线检查结果退出研究。治疗持续至氧饱和度高于96%或平均动脉血压下降30%或降至90mmHg以下。主要终点为死亡、需要机械通气和心肌梗死。分析采用意向性治疗。

结果

52例A组患者中有7例（13%）需要机械通气，52例B组患者中有21例（40%）需要机械通气（p=0.0041）。心肌梗死分别发生在9例（17%）和19例（37%）患者中（p=0.047）。A组1例患者和B组3例患者死亡（p=0.61）。这些终点中的一项或多项分别发生在13例（25%）和24例（46%）患者中（p=0.041）。