Campbell R W, Hutton I, Elton R A, Goodfellow R M, Taylor E
Br Heart J. 1983 Jun;49(6):557-63. doi: 10.1136/hrt.49.6.557.
Within six hours of suspected acute myocardial infarction, 791 patients entered a randomised double blind study of combined intravenous and oral tocainide for the prophylaxis of primary ventricular fibrillation. Acute myocardial infarction was confirmed in 559 patients, of whom 278 had received tocainide. The study was terminated on the basis of a sequential statistical analysis which showed that in these patients tocainide was unlikely to reduce the incidence of primary ventricular fibrillation by as much as 50%, primary ventricular fibrillation having occurred in 4% of the tocainide and 2% of the placebo patients. Significantly fewer tocainide treated patients were withdrawn for other serious ventricular arrhythmias. Mortality (1% in the tocainide group and 2% in the placebo group) was low with no statistically significant differences between the active and placebo groups. Unwanted effects of treatment were infrequent and rarely troublesome both in patients with and without acute myocardial infarction. These results suggest that in the dosage used in this study tocainide does not exert an antifibrillatory action in the early phase of acute myocardial infarction.
在疑似急性心肌梗死的6小时内，791例患者进入了一项关于静脉和口服妥卡尼联合预防原发性心室颤动的随机双盲研究。559例患者确诊为急性心肌梗死，其中278例接受了妥卡尼治疗。该研究基于序贯统计分析而终止，分析表明在这些患者中，妥卡尼不太可能将原发性心室颤动的发生率降低多达50%，妥卡尼治疗组原发性心室颤动发生率为4%，安慰剂组为2%。因其他严重室性心律失常而退出研究的妥卡尼治疗患者明显较少。死亡率较低（妥卡尼组为1%，安慰剂组为2%），活性药物组与安慰剂组之间无统计学显著差异。无论有无急性心肌梗死，治疗的不良反应都很少见，且很少造成困扰。这些结果表明，在本研究使用的剂量下，妥卡尼在急性心肌梗死早期不发挥抗纤颤作用。
