Stroke:阿替普酶在急性缺血性卒中发病6小时内对全因死亡率的影响(国际卒中试验-3)

2014-11-07 MedSci译 MedSci原创

通过静脉注射阿替普酶的快速溶栓治疗可以降低急性缺血性卒中后的致残率。在一项探索性分析中,我们调查相关患者在接受阿替普酶治疗后远期生存率是否存在不同。  研究方法: 在这个开放性治疗的、国际化、随机化、对照试验中,缺血性卒中患者被随机分配到两组,分别为6小时内开始接受静脉注射阿替普酶(0.9mg/kg)配合标准化治疗组(人数=1515)和单一进行标准化试验组(人数=1520

通过静脉注射阿替普酶的快速溶栓治疗可以降低急性缺血性卒中后的致残率。在一项探索性分析中,我们调查相关患者在接受阿替普酶治疗后远期生存率是否存在不同。 

研究方法:

在这个开放性治疗的、国际化、随机化、对照试验中,缺血性卒中患者被随机分配到两组,分别为6小时内开始接受静脉注射阿替普酶(0.9mg/kg)配合标准化治疗组(人数=1515)和单一进行标准化试验组(人数=1520)。我们随访患者直到其死亡,修改、删除最后生存的病例数。我们利用延迟随机、预测患者预后等方法来组织、招募患者(通过基线资料计算美国国立卫生研究院卒中量表[NIHSS]的评分和年龄)。卒中后7天、6个月、18个月等几个时间节点上,我们在试验组和对照组中得出了完全不同的死亡率。

研究结果:

在所有完成实验关键部分的患者(99.9%,3034、3035)中,阿替普酶与卒中后18个月内死亡率显著增高没有关联(0.6%[95%可信区间(CI),2.9%-++4.2]
P=0.72]。在卒中发生3小时内进行随机化的患者中,试验组相比对照组,18个月死亡率有所降低。试验组(40.6%[95%CI,42.6-52.7]),对照组(47.8%[95%CI,35.5-45.3];P=0.0434)。在试验组与对照组中,进行早期随机化的患者(<3小时)相比延迟随机化的患者(3-6小时),18个月死亡率的差异更加显著(+9%[95%CI,1-17];P=0.0317)。阿替普酶可以使预后不良的患者相比预后较好的患者18个月死亡率有更加明显的改善(+8%[95%CI,2-14;P=0.0091])。

总结:

这些国际卒中试验-3(IST-3)的探索性分析支持对急性缺血性卒中患者进行早期阿替普酶治疗以及对预后不良患者的治疗能够起到有效的改善作用,进一步对轻微卒中患者进行随机对照试验以重复以上的发现。

临床试验注册:

URL: http://www.controlled-trials.com. Unique identifier: ISRCTN25765518.

原始出处:

Whiteley WN1, Thompson D2, Murray G2, Cohen G2, Lindley RI2, Wardlaw J2, Sandercock P2.Effect of Alteplase Within 6 Hours of Acute Ischemic Stroke on All-Cause Mortality (Third International Stroke Trial).Stroke. 2014 Nov 4. pii: STROKEAHA.114.006890. [Epub ahead of print]


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