Recombinant activated factor VII for acute intracerebral hemorrhage
Recombinant activated factor VII for acute intracerebral hemorrhage
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DOI：
10.1056/nejmoa042991
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发表时间：
2005-02-24
影响因子：
158.5
通讯作者：
Steiner, T
中科院分区：
文献类型：
--
作者：
Mayer, SA;Brun, NC;Steiner, T
背景：脑内出血是中风的最不可治疗形式，与高死亡率有关。在脑出血发作后三个小时内进行计算机断层扫描（CT）的患者中，三分之一的患者与随后出血有关的血肿的体积增加。我们试图确定重组激活因子VII（RFVIIA）是否可以减少脑出血后的血肿生长。方法：我们随机分配了399例在发病后三个小时内通过CT诊断出脑部出血的患者，在发病后接受了次数（96名患者）或40 microg rfvviiia rfviia或40 microg。每公斤体重（108例患者），每公斤80 microg（92例），或基线扫描后一小时内，每公斤（103名患者）160个微型GOOG。主要结果指标是24小时时脑内出血的体积的变化百分比变化。在90天内评估临床结果。结果：安慰剂组的血肿容量比RFVIIA组增加。安慰剂组的平均增加为29％，相比之下，分别给出40个微型GOOG，80 microg和160 microg RFVIIA的16％，14％和11％，分别为每公斤RFVIIA（比较P = 0.01安慰剂组的三个RFVIIA组）。与安慰剂组相比，在三个治疗组中，脑出血体积的增长减少了3.3 ml，4.5 ml和5.8 ml（p = 0.01）。在安慰剂治疗的患者中，有69％的患者死亡或严重残疾（由Rankin量表得分为4至6），相比之下为55％，49％和54％的患者，有40、80的患者，分别为RFVIIA和160个微型RFVIIA（对于三个RFVIIA组与安慰剂组的比较P = 0.004）。接受安慰剂的患者的90天死亡率为29％，而三个RFVIIA组的死亡率为18％（p = 0.02）。严重的血栓栓塞不良事件（主要是心肌或脑梗塞）发生在7％的RFVIIA治疗患者中，而给定的安慰剂的患者中有2％发生（P = 0.12）。结论：在四个小时内治疗RFVIIA，在四个小时内治疗。限制血肿的生长，降低死亡率并改善90的功能结果天数，尽管血栓栓塞不良事件的频率很小。
BACKGROUND:Intracerebral hemorrhage is the least treatable form of stroke and is associated with high mortality. Among patients who undergo computed tomography (CT) within three hours after the onset of intracerebral hemorrhage, one third have an increase in the volume of the hematoma related to subsequent bleeding. We sought to determine whether recombinant activated factor VII (rFVIIa) can reduce hematoma growth after intracerebral hemorrhage.METHODS:We randomly assigned 399 patients with intracerebral hemorrhage diagnosed by CT within three hours after onset to receive placebo (96 patients) or 40 microg of rFVIIa per kilogram of body weight (108 patients), 80 microg per kilogram (92 patients), or 160 microg per kilogram (103 patients) within one hour after the baseline scan. The primary outcome measure was the percent change in the volume of the intracerebral hemorrhage at 24 hours. Clinical outcomes were assessed at 90 days. Results: Hematoma volume increased more in the placebo group than in the rFVIIa groups. The mean increase was 29 percent in the placebo group, as compared with 16 percent, 14 percent, and 11 percent in the groups given 40 microg, 80 microg, and 160 microg of rFVIIa per kilogram, respectively (P=0.01 for the comparison of the three rFVIIa groups with the placebo group). Growth in the volume of intracerebral hemorrhage was reduced by 3.3 ml, 4.5 ml, and 5.8 ml in the three treatment groups, as compared with that in the placebo group (P=0.01). Sixty-nine percent of placebo-treated patients died or were severely disabled (as defined by a modified Rankin Scale score of 4 to 6), as compared with 55 percent, 49 percent, and 54 percent of the patients who were given 40, 80, and 160 microg of rFVIIa, respectively (P=0.004 for the comparison of the three rFVIIa groups with the placebo group). Mortality at 90 days was 29 percent for patients who received placebo, as compared with 18 percent in the three rFVIIa groups combined (P=0.02). Serious thromboembolic adverse events, mainly myocardial or cerebral infarction, occurred in 7 percent of rFVIIa-treated patients, as compared with 2 percent of those given placebo (P=0.12).CONCLUSIONS:Treatment with rFVIIa within four hours after the onset of intracerebral hemorrhage limits the growth of the hematoma, reduces mortality, and improves functional outcomes at 90 days, despite a small increase in the frequency of thromboembolic adverse events.