17187例疑似急性心肌梗死患者静脉注射链激酶、口服阿司匹林、两者或两者均不使用的随机试验:ISIS-2。ISIS-2(第二国际梗死存活研究)协作组。

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17187例疑似急性心肌梗死患者静脉注射链激酶、口服阿司匹林、两者或两者均不使用的随机试验:ISIS-2。ISIS-2(第二国际梗死存活研究)协作组。

柳叶刀。1988年8月13日;2(8607):349-60。

PubMed ID
2899772 (PubMed视图
摘要

在疑似急性心肌梗死发作后24小时(中位数为5小时)内进入417家医院的17187名患者被随机分组,并与安慰剂对照,患者分别为:(i) 1小时静脉输注1.5 MU链激酶;(ii)一个月160毫克/天肠溶阿司匹林;(iii)两种积极治疗;或(iv)两者都不。单独使用链激酶和单独使用阿司匹林均能显著降低5周血管死亡率:分配链激酶输注的患者中有791/8592(9.2%),而分配安慰剂输注的患者中有1029/8595(12.0%)(几率降低:25% SD 4;2p小于0.00001);分配阿司匹林片剂的患者血管死亡804/8587例(9.4%),分配安慰剂片剂的患者血管死亡1016/8600例(11.8%)(比值降低:23% SD 4;2p小于0.00001)。链激酶和阿司匹林联合使用明显(2p < 0.0001)优于单独使用任何一种药物。它们对血管死亡的单独影响似乎是相加的:分配两种活性药物的患者中有343/4292(8.0%),而未分配两种活性药物的患者中有568/4300(13.2%)(几率降低:42% SD 5; 95% confidence limits 34-50%). There was evidence of benefit from each agent even for patients treated late after pain onset (odds reductions at 0-4, 5-12, and 13-24 hours: 35% SD 6, 16% SD 7, and 21% SD 12 for streptokinase alone; 25% SD 7, 21% SD 7, and 21% SD 12 for aspirin alone; and 53% SD 8, 32% SD 9, and 38% SD 15 for the combination of streptokinase and aspirin). Streptokinase was associated with an excess of bleeds requiring transfusion (0.5% vs 0.2%) and of confirmed cerebral haemorrhage (0.1% vs 0.0%), but with fewer other strokes (0.6% vs 0.8%). These "other" strokes may have included a few undiagnosed cerebral haemorrhages, but still there was no increase in total strokes (0.7% streptokinase vs 0.8% placebo infusion). Aspirin significantly reduced non-fatal reinfarction (1.0% vs 2.0%) and non-fatal stroke (0.3% vs 0.6%), and was not associated with any significant increase in cerebral haemorrhage or in bleeds requiring transfusion. An excess of non-fatal reinfarction was reported when streptokinase was used alone, but this appeared to be entirely avoided by the addition of aspirin. Those allocated the combination of streptokinase and aspirin had significantly fewer reinfarctions (1.8% vs 2.9%), strokes (0.6% vs 1.1%), and deaths (8.0% vs 13.2%) than those allocated neither. The differences in vascular and in all-cause mortality produced by streptokinase and by aspirin remain highly significant (2p less than 0.001 for each) after the median of 15 months of follow-up thus far available.

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