Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage
Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage
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DOI：
10.1056/nejmoa0707534
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发表时间：
2008-05-15
影响因子：
158.5
通讯作者：
Steiner, Thorsten
中科院分区：
文献类型：
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作者：
Mayer, Stephan A.;Brun, Nikolai C.;Steiner, Thorsten
背景：脑出血是最难治疗的卒中形式。我们进行了这项3期试验，以证实以前的研究，其中重组活化因子VII（rFVIIa）减少血肿的生长，改善生存和功能的结果。方法：我们将841名脑出血患者随机分配接受安慰剂治疗（268名患者）、20 μ g rFVIIa/kg体重（276名患者）或80 μ g rFVIIa/kg体重（297名患者）。主要终点是不良结局，定义为严重残疾或死亡，根据修改后的兰金规模90天后中风。结果：治疗与80微克rFVIIa每公斤导致在出血量的增长显着减少。安慰剂组24小时脑出血量平均增加26%，而rFVIIa 20 μ g/kg组为18%（P=0.09），80 μ g/kg组为11%（P
Background: Intracerebral hemorrhage is the least treatable form of stroke. We performed this phase 3 trial to confirm a previous study in which recombinant activated factor VII (rFVIIa) reduced growth of the hematoma and improved survival and functional outcomes.Methods: We randomly assigned 841 patients with intracerebral hemorrhage to receive placebo (268 patients), 20 mu g of rFVIIa per kilogram of body weight (276 patients), or 80 mu g of rFVIIa per kilogram (297 patients) within 4 hours after the onset of stroke. The primary end point was poor outcome, defined as severe disability or death according to the modified Rankin scale 90 days after the stroke.Results: Treatment with 80 mu g of rFVIIa per kilogram resulted in a significant reduction in growth in volume of the hemorrhage. The mean estimated increase in volume of the intracerebral hemorrhage at 24 hours was 26% in the placebo group, as compared with 18% in the group receiving 20 mu g of rFVIIa per kilogram (P=0.09) and 11% in the group receiving 80 mu g (P