一个随机、双盲、安慰剂对照研究的安全性和有效性静脉mcc - 135作为主要的兼职在急性心肌梗死患者经皮冠状动脉介入:评价左心室打捞mcc - 135的急性心肌梗死(进化)。

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张成泽本土知识,Weissman新泽西,皮卡德MH, Zile先生,小矮星V,沈年代,Tatsuno J, Hibberd毫克,Tzivoni D,瓦克陆地

我的心j . 2008年1月,155 (1):113. e1-8。Epub 2007年11月1日。

PubMed ID

18082500 (在PubMed

]

文摘

目的:这项研究的目的是测试假设细胞内钙调制5-methyl-2 - [piperazin-1-yl]苯磺酸一水(mcc - 135 (Caldaret);三菱制药公司,日本大阪)将保护左心室功能和减少梗塞大小主要患者接受经皮冠状动脉介入(PCI) st段抬高心肌梗死肝素)。背景:钙超载在细胞在缺血和再灌注期间不仅影响心肌的功能,也可能与肌细胞坏死。mcc - 135是第一个新类的药物,调节细胞内钙超载。方法:接受PCI术后急性STEMI患者随机分为安慰剂,低剂量和高剂量mcc - 135组。预定义的目标人群是那些前心肌梗死和pre-PCI TIMI年级流0或1。左心室射血分数(LVEF)在第五天是主要终点。次要终点包括梗塞尺寸测量单光子发射计算机断层扫描和血清心脏标记。临床随访到30天的结果。结果:500名患者中,141名合格的目标人群。 In this target population, there was no difference in the LVEF between 3 groups (placebo: 47.0% +/- 1.7% [mean +/- SEM], the low dose: 47.4% +/- 1.7%, the high dose: 45.1% +/- 2.0%). The infarct size on day 5 was not significantly different between the groups. The composite clinical outcome occurred in 25.5% in the placebo group, in 19.2% in the low-dose group, and in 34.2% in the high-dose group during a 30-day follow-up period (P = nonsignificant). MCC-135 appeared to be safe and well tolerated. CONCLUSION: There were no significant benefits of MCC-135 on preservation of LVEF and reduction of infarct size on day 5 in patients with STEMI undergoing primary PCI.

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药物: Caldaret