Kanemoto N, Goto Y, Hirosawa K, Kawai C, Kimata S, Yui Y, Yamamoto Y
Department of 1st Internal Medicine, Tokai University School of Medicine, Boseidai Isehara, Japan.
Jpn Circ J. 1991 Mar;55(3):250-61. doi: 10.1253/jcj.55.250.
Intravenous administrations of 2000 x 10(4)IU (33 mg) (rt-PA2) and 3000 x 10(4)IU (50 mg) (rt-PA3) of a new recombinant tissue plasminogen activator (rt-PA:TD-2061) derived from uterine endothelial cells and urokinase (UK) 96 x 10(4)IU were compared in a double blind, randomized trial of 198 patients with evolving myocardial infarction. All patients entered the trial within 6 h of the onset of symptoms and underwent baseline coronary angiography of the infarct-related coronary artery before thrombolytic therapy was instituted. Sixty minutes following thrombolytic therapy occluded infarct-related arteries were successfully reperfused in 41.5% of 66 patients in the UK, 76.4% of 72 patients in the rt-PA2, and 74.6% of 59 patients in the rt-PA3 group. Statistically significant differences were observed between the UK and rt-PA groups (p less than 0.01). Serum fibrinogen levels declined in all 3 groups at 60 min post-therapy by averages of 35.9 +/- 3.1% in the UK, 16.8 +/- 4.8% in the rt-PA2 and 17.5 +/- 4.5% in the rt-PA3 group. The difference between the UK and the rt-PA groups was statistically significant (p less than 0.01). Plasma plasminogen and alpha 2-plasmin inhibitor levels showed the same tendencies. Bleeding was the most commonly observed complication and was most commonly seen at the catheterization site. There was no difference in the incidence among the 3 groups. Hospital deaths occurred in 5.3%, 6.3%, and 4.7% of the cases in the UK, rt-PA2 and rt-PA3 groups, respectively. We conclude, therefore, that rt-PA achieves a significantly higher rate of recanalization with less extensive systemic fibrinogenolysis at the dose employed than does UK. The optimum intravenous dose of rt-PA for Japanese patients is considered to be 2000 x 10(4)IU (33 mg).
在一项针对198例进展期心肌梗死患者的双盲随机试验中，比较了静脉注射2000×10⁴IU（33mg）（rt-PA2）和3000×10⁴IU（50mg）（rt-PA3）的一种源自子宫内皮细胞的新型重组组织型纤溶酶原激活剂（rt-PA：TD-2061）以及96×10⁴IU尿激酶（UK）的效果。所有患者在症状发作后6小时内进入试验，并在开始溶栓治疗前对梗死相关冠状动脉进行基线冠状动脉造影。溶栓治疗60分钟后，UK组66例患者中有41.5%、rt-PA2组72例患者中有76.4%、rt-PA3组59例患者中有74.6%的梗死相关动脉闭塞成功再通。UK组与rt-PA组之间观察到统计学上的显著差异（p＜0.01）。治疗后60分钟时，所有3组的血清纤维蛋白原水平均下降，UK组平均下降35.9±3.1%，rt-PA2组下降16.8±4.8%，rt-PA3组下降17.5±4.5%。UK组与rt-PA组之间的差异具有统计学意义（p＜0.01）。血浆纤溶酶原和α2-纤溶酶抑制剂水平呈现相同趋势。出血是最常见的并发症，最常出现在导管插入部位。3组之间的发生率无差异。UK组、rt-PA2组和rt-PA3组的住院死亡率分别为5.3%、6.3%和4.7%。因此，我们得出结论，在所使用的剂量下，rt-PA比UK能实现显著更高的再通率，且全身纤维蛋白原溶解程度更低。对于日本患者，rt-PA的最佳静脉剂量被认为是2000×10⁴IU（33mg）。
