Acta Med Scand Suppl. 1983;674:1-129.
Patients who survive the acute phase of myocardial infarction have a high mortality in the following years. The mortality is largely due to sudden cardiac death or recurrent myocardial infarction. The main purpose of the present study was to clarify whether long-term treatment with the beta-adrenergic blocking agent timolol would improve prognosis in such patients. In order to recruit the sufficient number of patients to resolve this question a multicenter study was performed. This study, named "The Norwegian Multicenter Study On Timolol After Myocardial Infarction" was designed as a randomized, double-blind, placebo controlled trial. Twenty hospitals in Norway collaborated within an organizational structure aiming to achieve a maximum of standardization of study procedures. From a representative population of patients less than 75 years of age surviving the acute episode of infarction 52% were recruited for the study. The recruitment rate was high at all hospitals. The 1884 patients included were stratified into 3 risk groups before randomization. Risk Group I (18%) were patients with a recurrent infarction. Risk Group II (58%) were patients with a first infarction considered to be at high risk of sudden cardiac death. The rest, Risk Group III (22%) were patients at low risk. The placebo and timolol groups were similar with respect to most of the important baseline characteristics. Minor differences in a few characteristics did not affect the overall results as was shown by various statistical procedures including the Cox's proportional hazards regression model. The patients were followed 12 - 33 months after discharge from hospital with regular clinical examinations performed by the study investigators at the hospitals. Compliance was very good and no patient was lost to follow-up although 23.3% in the placebo group and 29.1% in the timolol group were withdrawn from the study regimen. The study demonstrated that long-term treatment with timolol improved prognosis in survivors of acute myocardial infarction. The most important finding was a highly statistically significant difference in life table mortality of 39.3% between the placebo group (21.9%) and the timolol group (13.3%) (p=0.0003). This difference was first of all due to a lower rate of sudden cardiac death in the timolol group (7.7%) compared to the placebo group (13.9%) (p=0.0001) when including events in the so-called "per protocol period".(ABSTRACT TRUNCATED AT 400 WORDS)
心肌梗死急性期存活的患者在接下来的几年中死亡率很高。死亡率主要归因于心脏性猝死或复发性心肌梗死。本研究的主要目的是阐明β-肾上腺素能阻滞剂噻吗洛尔的长期治疗是否会改善此类患者的预后。为了招募足够数量的患者来解决这个问题，开展了一项多中心研究。这项名为“挪威心肌梗死后噻吗洛尔多中心研究”的研究被设计为一项随机、双盲、安慰剂对照试验。挪威的20家医院在一个旨在实现研究程序最大程度标准化的组织结构内进行合作。在年龄小于75岁且存活过梗死急性期的代表性患者群体中，52%被招募参加该研究。所有医院的招募率都很高。纳入的1884例患者在随机分组前被分为3个风险组。风险组I（18%）为复发性梗死患者。风险组II（58%）为首次梗死且被认为有高心脏性猝死风险的患者。其余的风险组III（22%）为低风险患者。安慰剂组和噻吗洛尔组在大多数重要的基线特征方面相似。少数特征的微小差异并未影响总体结果，各种统计程序（包括Cox比例风险回归模型）都表明了这一点。患者出院后被随访12 - 33个月，由医院的研究调查人员进行定期临床检查。依从性非常好，没有患者失访，尽管安慰剂组有23.3%、噻吗洛尔组有29.1%的患者退出了研究方案。该研究表明，噻吗洛尔的长期治疗改善了急性心肌梗死幸存者的预后。最重要的发现是，安慰剂组（21.9%）和噻吗洛尔组（13.3%）的生命表死亡率在统计学上有高度显著差异（39.3%）（p = 0.0003）。当纳入所谓“符合方案期”的事件时，这种差异首先是由于噻吗洛尔组（7.7%）的心脏性猝死发生率低于安慰剂组（13.9%）（p = 0.0001）。（摘要截断于400字）
