Lewis H D, Davis J W, Archibald D G, Steinke W E, Smitherman T C, Doherty J E, Schnaper H W, LeWinter M M, Linares E, Pouget J M, Sabharwal S C, Chesler E, DeMots H
N Engl J Med. 1983 Aug 18;309(7):396-403. doi: 10.1056/NEJM198308183090703.
We conducted a multicenter, double-blind, placebo-controlled randomized trial of aspirin treatment (324 mg in buffered solution daily) for 12 weeks in 1266 men with unstable angina (625 taking aspirin and 641 placebo). The principal end points were death and acute myocardial infarction diagnosed by the presence of creatine kinase MB or pathologic Q-wave changes on electrocardiograms. The incidence of death or acute myocardial infarction was 51 per cent lower in the aspirin group than in the placebo group: 31 patients (5.0 per cent) as compared with 65 (10.1 per cent); P = 0.0005. Nonfatal acute myocardial infarction was 51 per cent lower in the aspirin group: 21 patients (3.4 per cent) as compared with 44 (6.9 per cent); P = 0.005. The reduction in mortality in the aspirin group was also 51 per cent--10 patients (1.6 per cent) as compared with 21 (3.3 per cent)--although it was not statistically significant; P = 0.054. There was no difference in gastrointestinal symptoms or evidence of blood loss between the treatment and control groups. Our data show that aspirin has a protective effect against acute myocardial infarction in men with unstable angina, and they suggest a similar effect on mortality.
我们进行了一项多中心、双盲、安慰剂对照的随机试验，对1266例不稳定型心绞痛男性患者给予阿司匹林治疗（每日324毫克缓冲溶液剂型），疗程12周（625例服用阿司匹林，641例服用安慰剂）。主要终点为死亡以及通过肌酸激酶MB升高或心电图病理性Q波改变确诊的急性心肌梗死。阿司匹林组死亡或急性心肌梗死的发生率比安慰剂组低51%：分别为31例（5.0%）和65例（10.1%）；P = 0.0005。阿司匹林组非致死性急性心肌梗死发生率低51%：分别为21例（3.4%）和44例（6.9%）；P = 0.005。阿司匹林组死亡率降低幅度也为51%——分别为10例（1.6%）和21例（3.3%）——尽管无统计学显著性差异；P = 0.（此处原文有误，应为0.054）。治疗组和对照组在胃肠道症状或失血证据方面无差异。我们的数据表明，阿司匹林对不稳定型心绞痛男性患者急性心肌梗死具有保护作用，并且提示对死亡率有类似作用。
