按体重给药与小剂量rt-PA治疗国人急性心肌梗死的随机对照研究

目的探讨国人应用重组组织型纤溶酶原激活剂（rt-PA）溶栓治疗急性心肌梗死（AMI）的合适剂量.方法所有入选患者随机分入按体重给药和小剂量rt-PA两个治疗组,按体重给药组（W组）93例,AMI患者在应用阿司匹林和肝素治疗基础上,首先给予8 mg的rt-PA静脉推注,继之按1 mg/kg算出需静脉点滴维持的总量给予静脉滴注（最低不少于42 mg,最高不多于92 mg）,90 min滴注完毕.小剂量组（L组）91例AMI患者,在应用阿司匹林和肝素治疗基础上,先给予8 mg的rt-PA静脉推注,继之42 mg在90 min内滴注完毕.观察终点：包括两组梗死相关动脉开通率（根据临床标准判断）、左室射血分数、发病30天主要心血管事件发生率.结果 W组93例患者中据临床标准判定再通者74例（79.6%）,L组91例患者中据临床标准判定再通者59例（64.8%）,两组比较有统计学意义（P=0.026）,W组左室射血分数略好于L组（P=0.259）和发病30天主要心血管事件发生率低于L组（P＜0.05）.结论按体重给药应用rt-PA治疗急性心肌梗死疗效和安全性优于国内常用的小剂量rt-PA治疗.

A randomized clinical trial on comparison of weight-adjusted dose with low dose recombinant tissue-type plasminogen activator on Chinese patients with acute myocardial infarction

Objective The aim of the study was to quest appropriate dose of recombinant tissue-type plasminogen activator (rt-PA) on Chinese patients with acute myocardial infarction.Methods All enrolled patients were randomized into weight-adjusted dose or low dose rt-PA group, and received a basal treatment with aspirin and heparin. Additionally, after an intravenous bolus of 8 mg rt-PA, patients in weight-adjusted dose group (n=93) were given an intravenous infusion of 42-92 mg rt-PA (1 mg/kg body weight), while patients in the low dose group (n=91) were treated with an intravenous infusion of 42 mg rt-PA over 90 minutes. The observational endpoint included reperfusion rate of the infarct-related artery by clinical criteria, left ventricular ejection fraction and major adverse cardiovascular events within 30 days in the two groups.Results There were 74 patients diagnosed reperfusion by clinical criteria in weight-adjusted dose group and 59 patients in low dose group(79.6% vs 64.8%,P=0.026). The left ventricular ejection fraction seemed to be better in weight-adjusted dose group than in low dose group( P=0.259). The major adverse cardiovascular events within 30 days were less in weight-adjusted dose group than in low dose group (P<0.05).Conclusion There was statistical significant superiority of weight-adjusted dose over low dose rt-PA in the treatment of Chinese patients with acute myocardial infarction.