Julian D G, Borthwick L S, Reid D, Jennings K P, Wainwright R J, Rodger J C, Wood D, Phillips W S
1 Freeman Hospital, Newcastle upon Tyne.
Drugs. 1987;33 Suppl 3:261-7. doi: 10.2165/00003495-198700333-00048.
90 patients were enrolled into this preliminary multicentre study of the efficacy and safety of 30 units intravenous anisoylated plasminogen streptokinase activator complex (APSAC) compared with placebo in patients with acute myocardial infarction. 45 patients received APSAC and 45 placebo; the groups were similar for age, weight and site of infarction. There were significantly more women treated with APSAC (p less than 0.02). The mean time to treatment was 3.3 hours after symptoms of myocardial infarction for APSAC and 3 hours for placebo. The 30-day mortality was 7 patients in the placebo group and 1 in the APSAC group (p = 0.058). Adverse events were generally minor and were of similar overall frequency in both groups. There were more haemorrhagic events with APSAC, from which all patients recovered, and more cardiovascular events with placebo including 2 deaths from cardiogenic shock. APSAC showed a trend towards a reduction in 30-day mortality. Experience from this study has led to the initiation of the APSAC in myocardial infarction multicentre mortality study (AIMS).
90名患者被纳入这项初步的多中心研究,该研究旨在比较30单位静脉注射茴香酰化纤溶酶原链激酶激活剂复合物(APSAC)与安慰剂对急性心肌梗死患者的疗效和安全性。45名患者接受APSAC治疗,45名患者接受安慰剂治疗;两组在年龄、体重和梗死部位方面相似。接受APSAC治疗的女性明显更多(p小于0.02)。APSAC组心肌梗死症状出现后平均治疗时间为3.3小时,安慰剂组为3小时。安慰剂组30天死亡率为7例,APSAC组为1例(p = 0.058)。不良事件一般较轻,两组总体发生率相似。APSAC组出血事件较多,但所有患者均康复,安慰剂组心血管事件较多,包括2例心源性休克死亡。APSAC显示出30天死亡率降低的趋势。这项研究的经验促使开展了APSAC治疗心肌梗死多中心死亡率研究(AIMS)。