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替奈普酶与替罗非班治疗ST段抬高型急性心肌梗死:一项随机试验的结果

Tenecteplase and tirofiban in ST-segment elevation acute myocardial infarction: results of a randomized trial.

作者信息

Ohman E Magnus, Van de Werf Frans, Antman Elliott M, Califf Robert M, de Lemos James A, Gibson C Michael, Oliverio Renee L, Harrelson Lynn, McCabe Carolyn, DiBattiste Peter, Braunwald Eugene

机构信息

Division of Cardiology, University of North Carolina, UNC Heart Center, Chapel Hill, NC, USA.

出版信息

Am Heart J. 2005 Jul;150(1):79-88. doi: 10.1016/j.ahj.2005.01.007.

Abstract

BACKGROUND

The combination of older reduced-dose fibrinolytic agents and platelet glycoprotein IIb/IIIa inhibitors has shown modest improvements in reperfusion and more striking improvements in ST-segment resolution after acute myocardial infarction. We performed a multicenter dose-ranging study of reduced doses of a newer fibrinolytic (tenecteplase) combined with tirofiban, a glycoprotein IIb/IIIa inhibitor.

METHODS

The first goal of the trial was to identify a dose or doses of tirofiban that, when combined with reduced-dose tenecteplase, would result in a higher incidence of Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow at 60 minutes versus full-dose tenecteplase alone. The second goal was to assess whether the optimum dose(s) from the first stage also would result in greater resolution of ST-segment elevation.

RESULTS

In all, 409 patients aged 18 to 75 years with myocardial infarction were enrolled. The incidence of TIMI grade 3 flow at 60 minutes did not differ significantly among dose groups, ranging from 50% to 68%. The corrected TIMI frame count likewise did not differ substantially (range 34-42). More patients given combined therapy had complete resolution of ST-segment elevation at 60 minutes compared with patients given tenecteplase alone. Major bleeding was infrequent, and no strokes occurred. Based on angiographic results of the first stage, the second planned stage of the study was not performed.

CONCLUSIONS

Although combination therapies were not associated with increased reperfusion compared with full-dose tenecteplase alone, similar TIMI flow grades were achieved despite reductions in tenecteplase doses. ST-segment resolution was more rapid and complete with combination therapy versus full-dose tenecteplase, suggesting enhanced microcirculatory perfusion to the infarct zone in this dose-ranging trial.

摘要

背景

在急性心肌梗死后,较老的低剂量纤溶药物与血小板糖蛋白IIb/IIIa抑制剂联合使用已显示出再灌注方面有适度改善,ST段分辨率有更显著改善。我们进行了一项多中心剂量范围研究,采用较低剂量的新型纤溶药物(替奈普酶)与糖蛋白IIb/IIIa抑制剂替罗非班联合使用。

方法

该试验的首要目标是确定与低剂量替奈普酶联合使用时,能使60分钟时心肌梗死溶栓(TIMI)3级血流发生率高于单独使用全剂量替奈普酶的替罗非班剂量。第二个目标是评估第一阶段的最佳剂量是否也会导致ST段抬高有更大程度的缓解。

结果

总共纳入了409例年龄在18至75岁的心肌梗死患者。各剂量组60分钟时TIMI 3级血流发生率无显著差异,范围为50%至68%。校正后的TIMI帧数同样无实质性差异(范围为34 - 42)。与单独接受替奈普酶治疗的患者相比,接受联合治疗的更多患者在60分钟时ST段抬高完全缓解。严重出血罕见,且未发生卒中。基于第一阶段的血管造影结果,未进行研究的第二个计划阶段。

结论

虽然与单独使用全剂量替奈普酶相比,联合治疗未使再灌注增加,但尽管替奈普酶剂量降低,仍达到了相似的TIMI血流分级。与全剂量替奈普酶相比,联合治疗使ST段分辨率更快且更完全,表明在该剂量范围试验中梗死区域的微循环灌注得到增强。

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