Morris J L, Zaman A G, Smyllie J H, Cowan J C
Department of Cardiology, General Infirmary at Leeds.
Br Heart J. 1995 Apr;73(4):310-9. doi: 10.1136/hrt.73.4.310.
To assess the possible benefits of intravenous isosorbide dinitrate in acute myocardial infarction and oral isosorbide mononitrate in subacute myocardial infarction.
316 patients presenting with acute myocardial infarction were entered into double blind placebo controlled clinical trials assessing infarct size by enzyme release, ventricular size and function by echocardiography, reperfusion by continuous 12 lead ST segment monitoring and late potentials by high resolution electrocardiography.
301 patients, of whom 292 (97%) received thrombolytic treatment, were randomised on admission to intravenous isosorbide dinitrate or placebo. Overall, there was no significant effect of treatment on infarct size, ST segment resolution, ventricular remodelling, or late potentials at day 3. A trend was observed towards a reduction in infarct size in patients with non-Q wave infarction treated with isosorbide dinitrate. Heterogeneity of nitrate effect was observed in relation to the degree of ST segment elevation on presentation with a clear benefit of isosorbide dinitrate in patients with moderate ST segment elevation (472 U/l v 704 U/l, P = 0.003) and a trend towards a deleterious effect in patients with marked ST segment elevation (1152 U/l v 1058 U/l, P = 0.2). ST segment re-elevation was more common among patients receiving nitrate treatment than in those assigned to placebo (29 v 16, P < 0.05). Some 160 patients underwent a further randomisation to sustained release isosorbide mononitrate or placebo on day 3. Echocardiographic volumes after 6 weeks of treatment were similar in the two groups.
No benefit was observed with administration of nitrates in the treatment groups as a whole for either acute or subacute infarction. There was, however, evidence of heterogeneity of effect in the different subgroups of acute infarction, and the possibility that nitrates may have differing actions in different groups of patients should be considered.
评估静脉注射硝酸异山梨酯在急性心肌梗死中的潜在益处以及口服单硝酸异山梨酯在亚急性心肌梗死中的潜在益处。
316例急性心肌梗死患者进入双盲安慰剂对照临床试验，通过酶释放评估梗死面积，通过超声心动图评估心室大小和功能，通过连续12导联ST段监测评估再灌注，通过高分辨率心电图评估晚电位。
301例患者（其中292例[97%]接受了溶栓治疗）入院时被随机分为静脉注射硝酸异山梨酯组或安慰剂组。总体而言，治疗在第3天时对梗死面积、ST段分辨率、心室重构或晚电位无显著影响。在用硝酸异山梨酯治疗的非Q波梗死患者中观察到梗死面积有减小趋势。观察到硝酸酯类药物的效应存在异质性，与就诊时ST段抬高程度有关，在中度ST段抬高患者中硝酸异山梨酯有明显益处（472 U/l对704 U/l，P = 0.003），而在显著ST段抬高患者中有有害作用趋势（1152 U/l对1058 U/l，P = 0.2）。ST段再次抬高在接受硝酸酯类治疗的患者中比在接受安慰剂治疗的患者中更常见（29例对16例，P < 0.05）。约160例患者在第3天进一步被随机分为接受缓释单硝酸异山梨酯组或安慰剂组。治疗6周后的超声心动图测量容积在两组中相似。
在整个治疗组中，无论是急性还是亚急性梗死，使用硝酸盐治疗均未观察到益处。然而，有证据表明急性梗死的不同亚组中存在效应异质性，应考虑硝酸盐在不同患者组中可能有不同作用的可能性。
