ASPIRIN, SULFINPYRAZONE, OR BOTH IN UNSTABLE ANGINA - RESULTS OF A CANADIAN MULTICENTER TRIAL

ASPIRIN, SULFINPYRAZONE, OR BOTH IN UNSTABLE ANGINA - RESULTS OF A CANADIAN MULTICENTER TRIAL
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DOI:
10.1056/nejm198511283132201
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发表时间:
1985-01-01
影响因子:
158.5
通讯作者:
TANSER, PH
TANSER, PH
中科院分区:
医学1区
文献类型:
--
作者:
CAIRNS, JA;GENT, M;TANSER, PH

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我们对555例在冠心病监护病房住院的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。患者接受了四种可能的治疗方案之一:阿司匹林(325 mg,每日四次),磺胺嘧啶(200 mg,每日四次),两者兼而有之,或两者都不。他们在住院后8天内进入试验,接受治疗和随访长达两年(平均18个月)。心源性死亡和非致命性心肌梗死的发生率,在服用阿司匹林的组中为8.6%,在其他组中为17.0%,表明服用阿司匹林的风险降低了51%(P = 0.008)。单独心源性死亡或任何原因死亡的相应数字在服用阿司匹林的组中为3.0%,在其他组中为11.7%,代表风险降低71%(P = 0.004)。意向治疗分析显示,阿司匹林治疗后心源性死亡或非致命性急性心肌梗死、单独心源性死亡和所有死亡的风险降低幅度较小,分别为30%(P = 0.072)、56%(P = 0.009)和43%(P = 0.035)。没有观察到亚磺酰草胺对任何结局事件的益处,也没有证据表明亚磺酰草胺和阿司匹林之间存在相互作用。结合先前的临床试验结果,这些发现为阿司匹林对不稳定型心绞痛患者的有益作用提供了强有力的证据。
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 regimes: aspirin (325 mg four times daily), sulfinpyrazone (200 mg four time 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.