在17187例疑似急性心肌梗死患者中,静脉注射链激酶、口服阿司匹林、两者兼用或两者不使用的随机试验:ISIS-2ISIS-2(第二次国际梗死生存研究)协作组。

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在17187例疑似急性心肌梗死患者中,静脉注射链激酶、口服阿司匹林、两者兼用或两者不使用的随机试验:ISIS-2ISIS-2(第二次国际梗死生存研究)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5小时)内进入417家医院的17,187名患者被随机分组,并采用安慰剂对照,(i) 1小时静脉输注1.5 MU的链激酶;(ii)一个月160mg /天肠溶膜阿司匹林;(iii)两种积极治疗;或者(iv)两者都不是。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为791/8592(9.2%),而分配安慰剂输注的患者为1029/8595(12.0%)(优势降低:25% SD 4;2p小于0.00001);分配阿司匹林片剂的患者血管死亡人数为804/8587(9.4%),而分配安慰剂片剂的患者为1016/8600(11.8%)(优势降低:23% SD 4;2p小于0.00001)。链激酶与阿司匹林联用优于单用(p < 0.0001)。它们对血管死亡的单独影响似乎是相加的:两种药物均使用的患者中有343/4292(8.0%),而两种药物均未使用的患者中有568/4300(13.2%)(比值降低: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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