Eur Heart J. 1985 Mar;6(3):199-226.
The effect of metoprolol on mortality and morbidity after 15 days, was compared with that of placebo in a double-blind randomised international trial (the MIAMI trial) in patients with definite or suspected acute myocardial infarction (AMI). Treatment with intravenous metoprolol (15 mg) or placebo was started shortly after the patient's arrival in hospital within 24 h of the onset of symptoms, and then oral treatment (200 mg daily) was continued for the study period (15 days). Of the 5778 patients included, 2901 were allocated to placebo and 2877 to metoprolol. Definite AMI was confirmed in 4127 patients. There were 142 deaths in the placebo group (4.9%) and 123 deaths in the metoprolol group (4.3%), a difference of 13 per cent with 95 per cent confidence limits of -8 to +33 per cent, not statistically significant (P = 0.29). Previously recorded risk indicators of mortality were analysed in retrospect. These indicated that there was a category which showed higher risk which contained approximately 30% of all randomized patients. In these, the mortality rate in the metoprolol treated group was 29% less than in the placebo group. In the remaining lower risk categories there was no difference between the treatment groups. This subset analysis must be interpreted with caution in view of the findings from other similar studies. Positive effects were observed on the incidence of definite AMI and on serum enzyme activity in patients treated early (less than 7 h). There was no significant effect on ventricular fibrillation but the number of episodes tended to be lower in the metoprolol treated patients during the later phase (6-15 days; 24 vs 54 episodes). The incidence of supraventricular tachyarrhythmias, the use of cardiac glycosides and other antiarrhythmics, and the need for pain-relieving treatment were significantly diminished by metoprolol amongst all randomised patients. Adverse events associated with metoprolol were infrequent, expected, and relatively mild.
在一项针对明确或疑似急性心肌梗死（AMI）患者的双盲随机国际试验（MIAMI试验）中，比较了美托洛尔与安慰剂对15天后死亡率和发病率的影响。患者症状发作后24小时内入院后不久，即开始静脉注射美托洛尔（15毫克）或安慰剂治疗，然后在研究期间（15天）继续口服治疗（每日200毫克）。纳入的5778例患者中，2901例被分配至安慰剂组，2877例被分配至美托洛尔组。4127例患者确诊为明确的AMI。安慰剂组有142例死亡（4.9%），美托洛尔组有123例死亡（4.3%），差异为13%，95%置信区间为-8%至+33%，无统计学意义（P = 0.29）。对先前记录的死亡率风险指标进行了回顾性分析。结果表明，有一个类别显示出较高风险，约占所有随机分组患者的30%。在这些患者中，美托洛尔治疗组的死亡率比安慰剂组低29%。在其余较低风险类别中，治疗组之间没有差异。鉴于其他类似研究的结果，对该亚组分析必须谨慎解释。在早期治疗（少于7小时）的患者中，观察到对明确AMI的发生率和血清酶活性有积极影响。对心室颤动没有显著影响，但在后期（6 - 15天），美托洛尔治疗的患者发作次数倾向于更低（24次对54次）。在所有随机分组的患者中，美托洛尔显著降低了室上性快速心律失常的发生率、强心苷和其他抗心律失常药物的使用以及止痛治疗的需求。与美托洛尔相关的不良事件很少见，属于预期情况，且相对较轻。
