剂量升级Desmoteplase对急性缺血性中风(德大):安全性和有效性的证据3至9小时后中风发病。

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可•福尔兰正AJ, Eyding D,阿尔瓦拉Y,利兹KR,罗利哈,Sachara C, Soehngen M, Warach年代尔W

剂量升级Desmoteplase对急性缺血性中风(德大):安全性和有效性的证据3至9小时后中风发病。

中风。2006年5月,37(5):1227 - 31所示。Epub 2006年3月30日。

PubMed ID

16574922 (在PubMed

]

文摘

背景和目的:Desmoteplase与有利的特性是一种新型的纤溶酶原激活物在体外与可用的代理。本研究评估静脉注射(IV)的安全性和有效性desmoteplase灌注/扩散不匹配患者MRI 3至9小时后出现急性缺血性中风。方法:德大是安慰剂对照、双盲、随机、剂量递增剂量研究调查90年microg desmoteplase /公斤,125 microg /公斤。合格标准包括基线国立卫生研究院的中风尺度(署)得分4到20和MRI灌注/扩散不匹配的证据。安全终点是症状性颅内出血。主要功效co-end点MRI再灌注治疗后4到8小时和良好的临床结果在90天。主要分析intent-to-treat。截断符号之前,目标人群,除违反特定患者MRI标准,定义。结果:37例患者随机接受治疗(intent-to-treat;安慰剂:n = 8; 90 microg/kg: n=14; 125 microg/kg: n=15). No symptomatic intracranial hemorrhage occurred. Reperfusion was achieved in 37.5% (95% CI [8.5; 75.5]) of placebo patients, 18.2% (2.3; 51.8) of patients treated with 90 microg/kg desmoteplase, and 53.3% (26.6; 78.7) of patients treated with 125 microg/kg desmoteplase. Good clinical outcome at 90 days occurred in 25.0% (3.2; 65.1) treated with placebo, 28.6% (8.4; 58.1) treated with 90 microg/kg desmoteplase and 60.0% (32.3; 83.7) treated with 125 microg/kg desmoteplase. In the target population (n=25), the difference compared with placebo increased and was statistically significant for good clinical outcome with 125 microg/kg desmoteplase (P=0.022). CONCLUSIONS: Treatment with IV desmoteplase 3 to 9 hours after ischemic stroke onset appears safe. At a dose of 125 microg/kg desmoteplase appeared to improve clinical outcome, especially in patients fulfilling all MRI criteria. The results of DEDAS generally support the results of its predecessor study, Desmoteplase in Acute Ischemic Stroke (DIAS).

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Desmoteplase