Cairns J A, Gent M, Singer J, Finnie K J, Froggatt G M, Holder D A, Jablonsky G, Kostuk W J, Melendez L J, Myers M G
N Engl J Med. 1985 Nov 28;313(22):1369-75. doi: 10.1056/NEJM198511283132201.
We performed a randomized, double-blind, placebo-controlled trial in 555 patients with unstable angina who were hospitalized in coronary care units. Patients received one of four possible treatment regimens: aspirin (325 mg four times daily), sulfinpyrazone (200 mg four times daily), both, or neither. They were entered into the trial within eight days of hospitalization and were treated and followed for up to two years (mean, 18 months). The incidence of cardiac death and nonfatal myocardial infarction, considered together, was 8.6 per cent in the groups given aspirin and 17.0 per cent in the other groups, representing a risk reduction with aspirin of 51 per cent (P = 0.008). The corresponding figures for either cardiac death alone or death from any cause were 3.0 per cent in the groups given aspirin and 11.7 per cent in the other groups, representing a risk reduction of 71 per cent (P = 0.004). Analysis by intention to treat yielded smaller risk reductions with aspirin of 30 per cent (P = 0.072), 56 per cent (P = 0.009), and 43 per cent (P = 0.035) for the outcomes of cardiac death or nonfatal acute myocardial infarction, cardiac death alone, and all deaths, respectively. There was no observed benefit of sulfinpyrazone for any outcome event, and there was no evidence of an interaction between sulfinpyrazone and aspirin. Considered together with the results of a previous clinical trial, these findings provide strong evidence for a beneficial effect of aspirin in patients with unstable angina.
我们对555例不稳定型心绞痛患者进行了一项随机、双盲、安慰剂对照试验，这些患者均入住冠心病监护病房。患者接受以下四种可能的治疗方案之一：阿司匹林（每日4次，每次325毫克）、磺吡酮（每日4次，每次200毫克）、两者联用或两者均不用。他们在住院8天内进入试验，并接受治疗和随访长达两年（平均18个月）。将心源性死亡和非致命性心肌梗死的发生率合并计算，服用阿司匹林的组为8.6%，其他组为17.0%，这表明阿司匹林使风险降低了51%（P = 0.008）。单独的心源性死亡或任何原因导致的死亡的相应数字，服用阿司匹林的组为3.0%，其他组为11.7%，这表明风险降低了71%（P = 0.004）。按意向性分析，对于心源性死亡或非致命性急性心肌梗死、单独的心源性死亡以及所有死亡的结局，阿司匹林使风险降低的幅度分别为30%（P = 0.072）、56%（P = 0.009）和43%（P = 0.035），降低幅度较小。未观察到磺吡酮对任何结局事件有获益，也没有证据表明磺吡酮与阿司匹林之间存在相互作用。结合先前一项临床试验的结果，这些发现为阿司匹林对不稳定型心绞痛患者有益提供了有力证据。
