Fitzgerald L J, Bennett E D
Department of Medicine, St George's Hospital Medical School, London, U.K.
Eur Heart J. 1990 Feb;11(2):120-6. doi: 10.1093/oxfordjournals.eurheartj.a059667.
We have conducted a randomized, double-blind, placebo-controlled multicentre trial of oral isosorbide 5-mononitrate (ISMN) in 360 patients with suspected acute myocardial infarction. Patients were stratified prior to analysis according to the presence or absence of left ventricular failure on admission. ISMN caused a significant reduction in systolic and diastolic blood pressure during the first 12 h. There was no significant effect on heart rate. Overall mortality was 4.9% in the ISMN group compared with 4.0% in controls at 5 days, and 14.1% compared with 10.5% at 6 months (NS). A non-significant reduction in mortality in the ISMN group with heart failure (ISMN 7.9%, placebo 12.9%, at 5 days) contrasted with a non-significant increase in mortality in patients without heart failure treated with ISMN (ISMN 4.1%, placebo 2.1%, at 5 days). Lignocaine was used in twice as many patients in the ISMN group as in placebo group (P less than 0.01), both with and without heart failure. Diamorphine usage was similar in the ISMN and control groups. Oral ISMN has similar haemodynamic effects to intravenous nitroglycerin, and can be of benefit in acute myocardial infarction with heart failure. However, our results question the use of nitrates in acute myocardial infarction in the absence of heart failure.
我们对360例疑似急性心肌梗死患者进行了一项口服单硝酸异山梨酯（ISMN）的随机、双盲、安慰剂对照多中心试验。在分析前，根据入院时是否存在左心室衰竭对患者进行分层。ISMN在最初12小时内导致收缩压和舒张压显著降低。对心率无显著影响。ISMN组5天时的总死亡率为4.9%，对照组为4.0%；6个月时分别为14.1%和10.5%（无显著性差异）。ISMN组中合并心力衰竭患者的死亡率有非显著性降低（5天时，ISMN组为7.9%，安慰剂组为12.9%），与之形成对比的是，接受ISMN治疗的无心力衰竭患者死亡率有非显著性升高（5天时，ISMN组为4.1%，安慰剂组为2.1%）。ISMN组使用利多卡因的患者数量是安慰剂组的两倍（P<0.01），无论有无心力衰竭。ISMN组和对照组中吗啡的使用情况相似。口服ISMN与静脉注射硝酸甘油具有相似的血流动力学效应，对合并心力衰竭的急性心肌梗死可能有益。然而，我们的结果对在无心力衰竭的急性心肌梗死中使用硝酸盐提出了质疑。
