Human recombinant factor VII for emergency reversal of coagulopathy in neurosurgical patients: A retrospective comparative study

Human recombinant factor VII for emergency reversal of coagulopathy in neurosurgical patients: A retrospective comparative study
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DOI:
10.1227/01.neu.0000180816.80626.c2
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发表时间:
2005-11-01
期刊:
影响因子:
4.8
通讯作者:
Tesoro, E
Tesoro, E
中科院分区:
医学1区
文献类型:
--
作者:
Roitberg, B;Emechebe-Kennedy, O;Tesoro, E

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目的:颅内出血神经外科患者的严重凝血障碍是一个常见且严重的问题。目前使用维生素 K 和新鲜冷冻血浆 (FFP) 的治疗在某些情况下可能太慢。有报道称,使用人重组因子 VII 可快速逆转凝血病。我们对我们使用因子 VII 的经验进行了一项回顾性对照研究。方法:在最初尝试用 FFP 逆转失败后,我们使用因子 VII 作为二线治疗。神经外科重症监护病房的 29 名患者接受了因子 VII;引入因子 VII 之前接受治疗的 24 名患者为对照受试者。各组按年龄、性别、凝血障碍原因和颅内出血情况进行匹配。 结果:初次给予 FFP 后,因子 VII 组的国际标准化比值 (INR) 从平均值 2.57 变为 1.67,对照组从 2.17 变为 1.85。在患病患者中,INR 趋于反弹。在施用因子 VII 之前,平均 INR 为 2.206。服用 1.4 mg 因子 VII 后,平均 INR 降至 1.12 (P < 0.05)。从入院开始测量,因子 VII 组的 INR 在 6.78 +/- 2.68 小时内恢复正常,对照组则在 47.44 +/- 9.88 小时内恢复正常 (P < 0.0005)。六名第七因子患者和六名对照受试者死亡。与仅接受维生素 K 和 FFP 治疗的患者相比,接受因子 VII 治疗的患者具有良好功能结果(格拉斯哥结果量表评分为 5 分)的患者数量更多(9 比 2,P = 0.04)。没有一例死亡是由于血栓并发症造成的。 VII因子组没有出现血栓并发症。结论:当需要紧急逆转凝血功能障碍时,VII因子是安全且高效的,并且可以改善功能结果。我们推测使用因子 VII 作为首选可能会导致 FFP 的使用减少,从而提高患者的安全性。
OBJECTIVE: Severe coagulopathy in a neurosurgical patient with intracranial hemorrhage is a common and serious problem. Current therapy with vitamin K and fresh-frozen plasma (FFP) may be too slow in certain situations. There are reports of rapid reversal of coagulopathy using human recombinant factor VII. We present a retrospective controlled study of our experience with factor VII.METHODS: We used factor VII as a second-line therapy after initial attempts at reversal with FFP had failed. Factor VII was given to 29 patients in the neurosurgical intensive care unit; 24 patients treated before the introduction of factor VII were control subjects. The groups were matched by age, sex, cause of coagulopathy, and presence of intracranial hemorrhage.RESULTS: After initial FFP administration, the international normalized ratio (INR) changed from a mean of 2.57 to 1.67 in the factor VII group and from 2.17 to 1.85 in control subjects. In ail patients, INR tended to rebound. Before administration of factor VII, the mean INR was 2.206. After 1.4 mg of factor VII, mean INR decreased to 1.12 (P < 0.05). Measured from admission, INR in the factor VII group normalized within 6.78 +/- 2.68 hours, and in control subjects, within 47.44 +/- 9.88 hours (P < 0.0005). Six factor VII patients and six control subjects died. The number of patients with good functional outcome (Glasgow Outcome Scale score of 5) was greater among patients treated with factor VII compared with those who received only vitamin K and FFP (nine versus two, P = 0.04). None of the deaths were the result of a thrombotic complication. There were no thrombotic complications in the factor VII group.CONCLUSION: Factor VII is safe and highly effective when emergency reversal of coagulopathy is desired and may improve the functional outcome. We speculate that the use of factor VII as first choice may result in decreased use of FFP and thus increase patient safety.