Intravenous tissue plasminogen activator and size of infarct, left ventricular function, and survival in acute myocardial infarction.
Intravenous tissue plasminogen activator and size of infarct, left ventricular function, and survival in acute myocardial infarction.
复制标题
静脉组织纤溶酶原激活剂与梗塞面积、左心室功能和急性心肌梗塞的存活率。
作者：
N. Kochenour;Pantaleo Greco;E. Letsky;R. Johnson;M. Contreras;C. Rodeck
研究目的--评价静脉注射重组组织型纤溶酶原激活剂对急性心肌梗死患者心肌梗死面积、左心功能及生存期的影响。设计--对急性心肌梗死患者在症状出现后5小时内进行的双盲、随机、安慰剂对照的前瞻性试验。单位--参加重组组织型纤溶酶原激活剂欧洲合作研究的26个转诊中心。患者--治疗组355例急性心肌梗死患者分配静脉注射重组纤溶酶原激活剂。对照组包括366名相似的患者，他们被分配接受安慰剂治疗。干预-所有患者在试验开始前立即给予阿司匹林250 mg和5000IU肝素团注。治疗组给予重组组织型纤溶酶原激活剂100 mg静脉滴注3h(静脉推注10 mg，1 h内50 mg，2 h内40 mg)。对照组给予安慰剂，方法相同。两组均给予全面抗凝治疗和阿司匹林治疗，直至血管造影术(入院后10~22d)。出院时给予β-受体阻滞剂。终点--10-22天的左心功能，酶学心肌梗死面积，临床病程，3个月随访存活期。测量和主要结果--在治疗开始后14天，接受治疗的患者的死亡率降低了51%(95%可信区间-76比1)，在3个月时降低了36%(-63到13)。在心肌梗死后3小时内进行治疗，14天内死亡率降低82%(-95%至-31%)，3个月内降低59%(-83%至-2%)。在住院14天内，治疗组心脏并发症的发生率低于对照组(心源性休克2.5%比6.0%；室颤3.4%比6.3%；心包炎6.2%比11.0%)，但前3个月血管成形术和/或动脉旁路手术的发生率高于对照组(15.8%比9.6%)。治疗组出血并发症较未治疗组多见。大多数是轻微的，但1.4%的接受治疗的患者在开始输液后三天内出现了颅内出血。由α-羟丁酸脱氢酶浓度确定的心肌梗塞的酶范围，治疗组比对照组小(20%，2p=0.0018)。治疗组左室射血分数增加2.2%(0.3~4.0)，舒张期和收缩末期容量分别减少6.0ml(-0.2~-11.9)和5.8ml(-0.9~-10.6)。结论--重组组织型纤溶酶原激活剂与肝素和阿司匹林联合使用可缩小梗塞范围，保留左心功能，减少并发症和心脏原因死亡，但增加出血并发症的风险。
STUDY OBJECTIVE--To assess effect of intravenous recombinant tissue type plasminogen activator on size of infarct, left ventricular function, and survival in acute myocardial infarction. DESIGN--Double blind, randomised, placebo controlled prospective trial of patients with acute myocardial infarction within five hours after onset of symptoms. SETTING--Twenty six referral centres participating in European cooperative study for recombinant tissue type plasminogen activator. PATIENTS--Treatment group of 355 patients with acute myocardial infarction allocated to receive intravenous recombinant plasminogen activator. Controls comprised 366 similar patients allocated to receive placebo. INTERVENTION--All patients were given aspirin 250 mg and bolus injection of 5000 IU heparin immediately before start of trial. Patients in treatment group were given 100 mg recombinant tissue plasminogen activator over three hours (10 mg intravenous bolus, 50 mg during one hour, and 40 mg during next two hours) by infusion. Controls were given placebo by same method. Full anticoagulation treatment and aspirin were given to both groups until angiography (10-22 days after admission). beta Blockers were given at discharge. END POINT--Left ventricular function at 10-22 days, enzymatic infarct size, clinical course, and survival to three month follow up. MEASUREMENTS AND MAIN RESULTS--Mortality was reduced by 51% (95% confidence interval -76 to 1) in treated patients at 14 days after start of treatment and by 36% (-63 to 13) at three months. For treatment within three hours after myocardial infarction mortality was reduced by 82% (-95 to -31) at 14 days and by 59% (-83 to -2) at three months. During 14 days in hospital incidence of cardiac complications was lower in treated patients than controls (cardiogenic shock, 2.5% v 6.0%; ventricular fibrillation, 3.4% v 6.3%; and pericarditis, 6.2% v 11.0% respectively), but that of angioplasty or artery bypass, or both was higher (15.8% v 9.6%) during the first three months. Bleeding complications were commoner in treated than untreated patients. Most were minor, but 1.4% of treated patients had intracranial haemorrhage within three days after start of infusion. Enzymatic size of infarct, determined by alpha hydroxybutyrate dehydrogenase concentrations, was less (20%, 2p = 0.0018) in treated patients than in controls. Left ventricular ejection fraction was 2.2% higher (0.3 to 4.0) and end diastolic and end systolic volumes smaller by 6.0 ml (-0.2 to -11.9) and 5.8 ml (-0.9 to -10.6), respectively, in treated patients. CONCLUSION--Recombinant tissue type plasminogen activator with heparin and aspirin reduces size of infarct, preserves left ventricular function, and reduces complications and death from cardiac causes but at increased risk of bleeding complications4+