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重组组织型纤溶酶原激活剂在急性心肌梗死中早期和晚期给药的双盲安慰剂对照研究。

A double blind placebo controlled study of early and late administration of recombinant tissue plasminogen activator in acute myocardial infarction.

作者信息

McNeill A J, Cunningham S R, Flannery D J, Dalzell G W, Wilson C M, Campbell N P, Khan M M, Patterson G C, Webb S W, Adgey A A

机构信息

Regional Medical Cardiology Centre, Royal Victoria Hospital, Belfast, Northern Ireland.

出版信息

Br Heart J. 1989 Apr;61(4):316-21. doi: 10.1136/hrt.61.4.316.

DOI:10.1136/hrt.61.4.316
PMID:2496740
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1216669/
Abstract

Within four hours of the onset of acute myocardial infarction 57 consecutive patients were randomised blindly to infusion of 150 mg recombinant tissue plasminogen activator (rt-PA) (group 1) over five hours or placebo (group 2) when they were first seen outside hospital or in the accident and emergency department. When they were admitted to the coronary care unit patients in group 1 also had placebo infused and those in group 2 were treated with rt-PA as well as placebo. Treatment with rt-PA started at a mean of 119 minutes (range 38-235) after the onset of pain in group 1 and 187 minutes (range 80-285) after the onset of pain in group. In 19 (79%) of 24 in group 1 and 16 of 25 (64%) in group 2 cardiac catheterisation 10-14 days after infarction showed thrombolysis in myocardial infarction grades 2 or 3. There was mean percentage shortening of the infarct related segments (Leighton method) of 16% in group 1 and 10.3% in group 2. For patients with anterior infarction mean percentage shortening was 20.5% in group 1 and 12.2% in group 2. Although there was no significant difference in global ejection fraction as assessed by contrast ventriculography or radionuclide ventriculography the infarct related regional third ejection fraction (a measure of the function of the territory of the affected coronary artery) was significantly improved by early treatment (41% group 1 and 28% group 2). Assessment of infarct size by the QRS scoring method of Palmeri showed QRS score less than or equal to 15/25 patients in group 1 and 8/27 in group 2. Nine patients developed 11 episodes of ventricular fibrillation; all patients in whom ventricular fibrillation developed during treatment with rt-PA were successfully resuscitated. There was no clinically significant bleeding. In seven (12%) patients clinical and electrocardiographic criteria suggested reocclusion. Five patients died from cardiac causes. Prehospital administration of rt-PA was feasible and significantly reduced the delay before thrombolysis was started. Earlier treatment improved myocardial function in the the infarct area and reduced the infarct size.

摘要

在急性心肌梗死发作后的4小时内,57例连续患者在首次于院外或急诊科被发现时,被随机盲法分为两组,一组在5小时内输注150毫克重组组织型纤溶酶原激活剂(rt-PA)(第1组),另一组输注安慰剂(第2组)。当他们被收入冠心病监护病房时,第1组患者也输注安慰剂,第2组患者则同时接受rt-PA和安慰剂治疗。第1组患者在疼痛发作后平均119分钟(范围38 - 235分钟)开始接受rt-PA治疗,第2组患者在疼痛发作后187分钟(范围80 - 285分钟)开始治疗。梗死10 - 14天后,第1组24例中的19例(79%)和第2组25例中的16例(64%)进行了心脏导管检查,结果显示心肌梗死溶栓分级为2级或3级。采用雷顿方法,第1组梗死相关节段平均缩短百分比为16%,第2组为10.3%。对于前壁梗死患者,第1组平均缩短百分比为20.5%,第2组为12.2%。尽管通过造影心室造影或放射性核素心室造影评估的整体射血分数没有显著差异,但早期治疗使梗死相关区域的第三射血分数(衡量受影响冠状动脉供血区域功能的指标)得到了显著改善(第1组为41%,第2组为28%)。采用帕尔梅里的QRS评分法评估梗死面积,第1组25例中有15例患者QRS评分小于或等于15,第2组27例中有8例。9例患者发生了11次心室颤动;所有在rt-PA治疗期间发生心室颤动的患者均成功复苏。没有发生具有临床意义的出血。7例(12%)患者的临床和心电图标准提示再闭塞。5例患者死于心脏原因。院前给予rt-PA是可行的,并且显著减少了开始溶栓前的延迟。早期治疗改善了梗死区域的心肌功能,减小了梗死面积。

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