Hansteen V, Møinichen E, Lorentsen E, Andersen A, Strøm O, Søiland K, Dyrbekk D, Refsum A M, Tromsdal A, Knudsen K, Eika C, Bakken J, Smith P, Hoff P I
Br Med J (Clin Res Ed). 1982 Jan 16;284(6310):155-60. doi: 10.1136/bmj.284.6310.155.
A prospective, randomised, double-blind study was performed to compare the effects of propranolol and placebo on sudden cardiac death in a high-risk group of patients who survived acute myocardial infarction. Altogether 4929 patients with definite acute myocardial infarction were screened for inclusion: 574 (11.6%) died before randomisation, and 3795 (77%) were excluded. Five hundred and sixty patients aged 35 to 70 years were stratified into two risk groups and randomly assigned treatment with propranolol 40 mg four times a day or placebo. Treatment started four to six days after the infarction. By one year there had been 11 sudden deaths in the propranolol group and 23 in the placebo group (p less than 0.038, two-tailed test analysed according to the "intention-to-treat" principle). Altogether there were 25 deaths in the propranolol group and 37 in the placebo group (P less than 0.12), with 16 and 21 non-fatal reinfarctions respectively. A quarter of the patients were withdrawn from each group. Withdrawal because of heart failure during the first two weeks of treatment was significantly more common among propranolol-treated patients than among the controls, but thereafter the withdrawal rate was the same. The significant reduction in sudden death was comparable with that after alprenolol, practolol, and timolol, which suggests that the mechanism of prevention is beta-blockade rather than any other pharmacological property of the individual drugs.
进行了一项前瞻性、随机、双盲研究,以比较普萘洛尔和安慰剂对急性心肌梗死存活的高危患者群体心源性猝死的影响。共筛查了4929例确诊为急性心肌梗死的患者以纳入研究:574例(11.6%)在随机分组前死亡,3795例(77%)被排除。560例年龄在35至70岁的患者被分层为两个风险组,并随机分配接受每日4次、每次40 mg普萘洛尔或安慰剂治疗。治疗在心肌梗死后4至6天开始。到一年时,普萘洛尔组有11例心源性猝死,安慰剂组有23例(P<0.038,根据“意向性治疗”原则进行双尾检验)。普萘洛尔组共有25例死亡,安慰剂组有37例(P<0.12),分别有16例和21例非致命性再梗死。每组有四分之一的患者退出研究。在治疗的前两周,因心力衰竭退出的情况在接受普萘洛尔治疗的患者中比对照组更为常见,但此后退出率相同。心源性猝死的显著降低与阿普洛尔、普拉洛尔和噻吗洛尔治疗后的情况相当,这表明预防机制是β受体阻滞,而非各药物的任何其他药理特性。