Lancet. 1988 Mar 12;1(8585):545-9.
A randomised double-blind placebo-controlled clinical trial was undertaken to assess survival after a single 30 unit intravenous dose of anisoylated plasminogen streptokinase activator complex (APSAC) within 6 h of onset of acute myocardial infarction. A planned interim analysis of mortality data was undertaken after 1004 patients had been followed for at least 30 days after randomisation. 61 (12.2%) of 502 patients on placebo died within 30 days compared with 32 (6.4%) of 502 patients on APSAC (p = 0.0016). Because of this 47% reduction in 30-day mortality (95% confidence interval 21-65%) patient entry to the trial was terminated. Preliminary 1 year mortality data show a similar trend. Percentage mortality reduction with APSAC was similar whether time since onset of symptoms was 0-4 h (660 patients) or 4-6 h (344 patients). Adverse events were few. These findings add to evidence that intravenous thrombolytic therapy after myocardial infarction offers a substantial reduction in mortality.
开展了一项随机双盲安慰剂对照临床试验,以评估急性心肌梗死发病6小时内单次静脉注射30单位茴香酰化纤溶酶原链激酶激活剂复合物(APSAC)后的生存率。在1004例患者随机分组后至少随访30天,对死亡率数据进行了计划中的中期分析。安慰剂组502例患者中有61例(12.2%)在30天内死亡,而APSAC组502例患者中有32例(6.4%)死亡(p = 0.0016)。由于30天死亡率降低了47%(95%置信区间21-65%),该试验的患者入组被终止。初步的1年死亡率数据显示出类似趋势。无论症状发作后的时间是0-4小时(660例患者)还是4-6小时(344例患者),APSAC降低死亡率的百分比相似。不良事件很少。这些发现进一步证明,心肌梗死后静脉溶栓治疗可显著降低死亡率。