Kanemoto N, Goto Y, Hirosawa K, Kawai C, Kimata S, Yui Y, Yamamoto Y
1st Department of Internal Medicine, Tokai University School of Medicine, Boseidai Isehara, Japan.
Jpn Circ J. 1990 Jan;54(1):71-81. doi: 10.1253/jcj.54.71.
The efficacy and safety of intravenous infusion of human tissue-type plasminogen activator (rt-PA), developed in Japan (TD-2061), were investigated in 205 patients (154 men and 51 women) with evolving myocardial infarction (EMI). TD-2061 was given at a rate of 3.2 to 50 mg over 1 h after angiographic documentation of complete or subtotal (99%) occlusion. Nineteen patients were excluded as they did not meet the inclusion criteria. A total of 186 patients were divided into 6 groups according to the total dose given: Group I, 3.2 mg, 10 patients (pts); Group II, 6.4 mg, 15 pts; Group III, 12.8 mg, 15 pts; Group IV, 25.6 mg, 38 pts; Group V, 33.3 mg, 70 pts; Group VI, 50.0 mg, 38 pts. Ages ranged from 30 to 70 years (mean 60 +/- 1). Coronary angiography was done at 30 min and 1 h. In patients with TIMI grades 0 and 1, reperfusion was accomplished after 1 h in 22% of Group I, 50% of Group II, 64% of Group III, 70% of Group IV, 67% of Group V, and 74% of Group VI patients. Complications were hypotension, nausea and vomiting, bradycardia and bleeding at the puncture site. These findings suggest that clot-selective coronary thrombolysis can be induced in patients with EMI by means of human tissue-type plasminogen activator without concomitant induction of a severe systemic lytic state. The optimal dose for Japanese patients is considered to be 33.3-50.0 mg from the standpoint of reperfusion.
在205例进展性心肌梗死（EMI）患者（154例男性和51例女性）中研究了日本研发的静脉输注人组织型纤溶酶原激活剂（rt-PA，TD-2061）的疗效和安全性。在血管造影证实完全或次全（99%）闭塞后，TD-2061以3.2至50毫克的剂量在1小时内输注。19例患者因不符合纳入标准而被排除。根据给药总剂量，将186例患者分为6组：第一组，3.2毫克，10例患者（pts）；第二组，6.4毫克，15例pts；第三组，12.8毫克，15例pts；第四组，25.6毫克，38例pts；第五组，33.3毫克，70例pts；第六组，50.0毫克，38例pts。年龄范围为30至70岁（平均60±1）。在30分钟和1小时时进行冠状动脉造影。在TIMI分级为0和1的患者中，第一组22%、第二组50%、第三组64%、第四组70%、第五组67%和第六组74%的患者在1小时后实现再灌注。并发症为低血压、恶心和呕吐、心动过缓和穿刺部位出血。这些发现表明，通过人组织型纤溶酶原激活剂可在EMI患者中诱导血栓选择性冠状动脉溶栓，而不会同时诱导严重的全身溶解状态。从再灌注的角度来看，日本患者的最佳剂量被认为是33.3 - 50.0毫克。
