重组活化凝血因子VII对脑出血后健康相关生活质量的影响。

Impact of recombinant activated factor VII on health-related quality of life after intracerebral hemorrhage.

作者信息

Diringer Michael N, Ferran Jean-Marc, Broderick Joseph, Davis Stephen, Mayer Stephan A, Steiner Thorsten, Brun Nikolai C, Skolnick Brett E, Christensen Michael C

机构信息

Department of Neurology, Washington University School of Medicine, St. Louis, MO 63110, USA.

出版信息

Cerebrovasc Dis. 2007;24(2-3):219-25. doi: 10.1159/000104481. Epub 2007 Jun 28.

DOI:10.1159/000104481

PMID:17630481

Abstract

BACKGROUND

We recently demonstrated that recombinant activated factor VII (rFVIIa) given to patients presenting within 3 h of acute spontaneous intracerebral hemorrhage (ICH) reduces mortality (18% vs. 29%) and poor outcome (modified Rankin Scale, mRS, 4-6, 53 vs. 69%). This analysis was performed to determine the impact of rFVIIa on health-related quality of life (HRQoL) in those patients.

METHODS

In a prospective, randomized controlled trial, 399 patients (mean age, 66 years) received placebo, 40, 80 or 160 microg/kg of rFVIIa within 4 h of acute ICH. At 90 days, HRQoL was assessed with the EuroQoL (EQ-5D), a 5-dimensional measure of health which also includes the Visual Analogue Scale. Additionally, each level of the 90-day mRS was adjusted, using 4 different previously published utility values, to obtain a clearer picture of perceived HRQoL.

RESULTS

Among the 5 dimensions of EQ-5D, only mobility rating was significantly better for rFVIIa-treated patients (serious problems, 34 vs. 54%; p = 0.01). Yet, the utility value (scaled 1.0 = perfect health and 0.0 = dead) associated with the composite EQ-5D demonstrated significantly better HRQoL (0.48 vs. 0.36; p = 0.01). This was also true for the EQ-5D Visual Analogue Scale score (44 vs. 36; p = 0.04). Finally, all 4 algorithms for applying utility scores to the mRS indicated that rFVIIa was associated with significantly better perceived HRQoL (all p < 0.006).

CONCLUSIONS

Treatment with rFVIIa within 4 h of acute spontaneous ICH improves HRQoL.

摘要

背景

我们最近证明，在急性自发性脑出血（ICH）3小时内给予患者重组活化因子VII（rFVIIa）可降低死亡率（18%对29%）和不良预后（改良Rankin量表，mRS，4 - 6分，53%对69%）。进行该分析以确定rFVIIa对这些患者健康相关生活质量（HRQoL）的影响。

方法

在一项前瞻性、随机对照试验中，399例患者（平均年龄66岁）在急性ICH 4小时内接受安慰剂、40、80或160μg/kg的rFVIIa。在90天时，使用欧洲五维度健康量表（EQ - 5D）评估HRQoL，这是一种5维度健康测量方法，还包括视觉模拟量表。此外，使用4种不同的先前发表的效用值对90天mRS的每个等级进行调整，以更清楚地了解感知到的HRQoL。

结果

在EQ - 5D的5个维度中，只有rFVIIa治疗的患者的活动能力评分显著更好（严重问题，34%对54%；p = 0.01）。然而，与综合EQ - 5D相关的效用值（范围为1.0 = 完美健康，0.0 = 死亡）显示HRQoL显著更好（0.48对0.36；p = 0.01）。EQ - 5D视觉模拟量表评分也是如此（44对36；p = 0.04）。最后，将效用评分应用于mRS的所有4种算法均表明，rFVIIa与显著更好的感知HRQoL相关（所有p < 0.006）。