医学
改良兰金量表
安慰剂
可视模拟标度
随机对照试验
生活质量(医疗保健)
冲程(发动机)
公式-5D
物理疗法
纤溶剂
麻醉
内科学
健康相关生活质量
缺血性中风
组织纤溶酶原激活剂
缺血
疾病
替代医学
护理部
病理
工程类
机械工程
作者
Märit Jensen,Susanne Sehner,Bastian Cheng,Eckhard Schlemm,Fanny Quandt,Ewgenia Barow,Karl Wegscheider,Florent Boutitie,Martin Ebinger,Matthias Endres,Jochen B. Fiebach,Vincent Thijs,Robin Lemmens,Keith W. Muir,Norbert Nighoghossian,Salvador Pedraza,Claus Z Simonsen,Götz Thomalla,Christian Gerloff
出处
期刊:Neurology
[Ovid Technologies (Wolters Kluwer)]
日期:2023-01-10
卷期号:100 (2)
被引量:2
标识
DOI:10.1212/wnl.0000000000201375
摘要
Background and Objectives
Intravenous alteplase improves functional outcome after acute ischemic stroke. However, little is known about the effects on self-reported health-related quality of life (HRQoL). Methods
WAKE-UP was a multicenter, randomized, placebo-controlled trial of MRI-guided intravenous alteplase in stroke with unknown onset time. HRQoL was assessed using the EuroQol five-dimensional questionnaire (EQ-5D) at 90 days, comprising the EQ-5D index and the EQ visual analogue scale (VAS). Functional outcome was assessed by the modified Rankin Scale (mRS). We calculated the effect of treatment on EQ-5D index and EQ VAS using multiple linear regression models. Mediation analysis was performed on stroke survivors to explore the extent to which the effect of alteplase on HRQoL was mediated by functional outcome. Results
Among 490 stroke survivors, the EQ-5D index was available for 452 (92.2%), of whom 226 (50%) were assigned to treatment with alteplase and 226 (50%) to placebo. At 90 days, mean EQ-5D index was higher, reflecting a better health state, in patients randomized to treatment with alteplase than with placebo (0.75 vs 0.67) with an adjusted mean difference of 0.07 (95% CI 0.02–0.12, p = 0.005). In addition, mean EQ VAS was higher with alteplase than with placebo (72.6 vs 64.9), with an adjusted mean difference of 7.6 (95% CI 3.9–11.8, p < 0.001). Eighty-five percent of the total treatment effect of alteplase on the EQ-5D index was mediated using the mRS score while there was no significant direct effect. By contrast, the treatment effect on the EQ VAS was mainly through the direct pathway (60%), whereas 40% was mediated by the mRS. Discussion
Assessment of patient-reported outcome measures reveals a potential benefit of intravenous alteplase for HRQoL beyond improvement of functional outcome. Trial Registration Information
ClinicalTrials.gov number, NCT01525290; EudraCT number, 2011-005906-32.
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