A prospective, randomized, double-blind multicenter trial of a single bolus injection of the novel modified t-PA E6010 in the treatment of acute myocardial infarction: Comparison with native t-PA

被引:35
作者
Kawai, C
Yui, Y
Hosoda, S
Nobuyoshi, M
Suzuki, S
Sato, H
Takatsu, F
Motomiya, T
Kanmatsuse, K
Kodama, K
Yabe, Y
Minamino, T
Kimata, SI
Nakashima, M
Sugiyama, M
Sone, T
Hiasa, Y
Kijima, M
Nakamura, N
Hayasaki, K
Abe, H
Kadowaki, K
Murayama, H
Joh, T
Katagiri, T
Watanabe, S
Dohi, K
Tateda, K
Murata, M
Hayashida, N
Arita, M
Sakai, K
Kita, T
Toda, H
Meguro, T
Harada, M
Higuma, N
Nagai, T
Takizawa, A
Hirayama, H
Murakami, E
Hirose, K
Ishise, S
Shimomura, K
Inada, M
Chino, M
Hiramori, K
Yokoyama, K
Munakata, T
Takase, S
机构
[1] KYOTO UNIV HOSP, KYOTO 606, JAPAN
[2] TOKYO WOMENS MED COLL, TOKYO 162, JAPAN
[3] KOKURA MEM HOSP, KITAKYUSHU, FUKUOKA, JAPAN
[4] SAKAKIBARA HEART INST, TOKYO, JAPAN
[5] HIROSHIMA CITY HOSP, HIROSHIMA, JAPAN
[6] ANJO KOSEI HOSP, ANJO, AICHI, JAPAN
[7] TOKYO METROPOLITAN HIROO GEN HOSP, TOKYO, JAPAN
[8] NIHON UNIV, SURUGADAI HOSP, TOKYO, JAPAN
[9] OSAKA POLICE HOSP, OSAKA, JAPAN
[10] TOHO UNIV, SCH MED, TOKYO, JAPAN
[11] SAKURABASHI WATANABE HOSP, OSAKA, JAPAN
[12] TOKYO WOMENS MED COLL, AOYAMA HOSP, TOKYO 162, JAPAN
[13] HAMAMATSU UNIV SCH MED, HAMAMATSU, SHIZUOKA 43131, JAPAN
关键词
D O I
10.1016/S0735-1097(97)00074-0
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives. This prospective, randomized, double-blind multicenter trial evaluated the efficacy and safety of a single bolus injection of the novel modified tissue-type plasminogen activator (t-PA) E6010 in the treatment of acute myocardial infarction compared with that of native t-PA. Background. E6010 is a novel modified t-PA with a prolonged half-life (t(1/2) alpha greater than or equal to 23 min) compared with native t-PA (t(1/2) alpha = 4 min). E6010 can be administered in patients as a single intravenous bolus injection, and early recanalization can be expected. Methods. The efficacy of E6010 was compared with that of native t-PA in 199 patients,vith acute myocardial infarction who were treated within 6 h of onset in a prospective, randomized, double-blind multicenter trial. Patients were given either 0.22 mg/kg body weight of E6010 intravenously over 2 min or native t-PA (tisokinase) 28.8 mg or 14.4 million IU (10% of the total dose over 1 to 2 min, the remainder infused over 60 min). Results. The primary end point was the recanalization rate of the infarct-related coronary artery at 60 min after the start of treatment. Time to reperfusion was shorter in the E6010 group than in the native t-PA group. Thrombolysis in Myocardial Infarction how grade 2 or 3 recanalization at 15, 30, 45 and 60 min after administration was observed in 37%, 62%, 74% and 79% (95% confidence interval [CI] 70% to 87%) of the E6010-treated patients and in 14%, 32%, 50% and 65% (95% CI 55% to 74%) of native t-PA-treated patients, respectively (p = 0.032 at 60 min). Conclusions. The present study indicates that, compared with native t-PA, a single bolus injection of E6010 over 2 min produces a higher rate of early recanalization of the infarct-related coronary artery without fatal bleeding complications. (C) 1997 by the American College of Cardiology.
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收藏
页码:1447 / 1453
页数:7
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