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依达拉奉对真实世界急性缺血性脑卒中患者神经症状的影响。

Effect of Edaravone on Neurological Symptoms in Real-World Patients With Acute Ischemic Stroke.

机构信息

From the Department of General Internal Medicine, Fukushima Medical University, Japan (Susumu Kobayashi).

Human Health Sciences, Kyoto University Graduate School of Medicine, Japan (S.F., T.I.).

出版信息

Stroke. 2019 Jul;50(7):1805-1811. doi: 10.1161/STROKEAHA.118.024351. Epub 2019 Jun 5.

DOI:10.1161/STROKEAHA.118.024351
PMID:31164072
Abstract

Background and Purpose- In Japan, nearly half of ischemic stroke patients receive edaravone for acute treatment. The purpose of this study was to assess the effect of edaravone on neurological symptoms in patients with ischemic stroke stratified by stroke subtype. Methods- Study subjects were 61 048 patients aged 18 years or older who were hospitalized ≤14 days after onset of an acute ischemic stroke and were registered in the Japan Stroke Data Bank, a hospital-based multicenter stroke registration database, between June 2001 and July 2013. Patients were stratified according to ischemic stroke subtype (large-artery atherosclerosis, cardioembolism, small-vessel occlusion, and cryptogenic/undetermined) and then divided into 2 groups (edaravone-treated and no edaravone). Neurological symptoms were evaluated using the National Institutes of Health Stroke Scale (NIHSS). The primary outcome was changed in neurological symptoms during the hospital stay (ΔNIHSS=NIHSS score at discharge-NIHSS score at admission). Data were analyzed using multivariate linear regression with inverse probability of treatment weighting after adjusting for the following confounding factors: age, gender, and systolic and diastolic blood pressure at the start of treatment, NIHSS score at admission, time from stroke onset to hospital admission, infarct size, comorbidities, concomitant medication, clinical department, history of smoking, alcohol consumption, and history of stroke. Results- After adjusting for potential confounders, the improvement in NIHSS score from admission to discharge was greater in the edaravone-treated group than in the no edaravone group for all ischemic stroke subtypes (mean [95% CI] difference in ΔNIHSS: -0.46 [-0.75 to -0.16] for large-artery atherosclerosis, -0.64 [-1.09 to -0.2] for cardioembolism, and -0.25 [-0.4 to -0.09] for small-vessel occlusion). Conclusions- For any ischemic stroke subtype, edaravone use (compared with no use) was associated with a greater improvement in neurological symptoms, although the difference was small (<1 point NIHSS) and of limited clinical significance.

摘要

背景与目的-在日本,近半数缺血性脑卒中患者接受依达拉奉进行急性治疗。本研究旨在评估依达拉奉对不同缺血性脑卒中亚型患者神经症状的影响。方法-研究对象为 61048 例年龄在 18 岁及以上的急性缺血性脑卒中患者,他们在发病后 14 天内住院,并于 2001 年 6 月至 2013 年 7 月期间在日本脑卒中数据库(一个基于医院的多中心脑卒中登记数据库)中登记。患者根据缺血性脑卒中亚型(大动脉粥样硬化、心源性栓塞、小血管闭塞和不明原因/确定原因不明)进行分层,然后分为 2 组(依达拉奉治疗组和未用依达拉奉组)。神经症状采用国立卫生研究院脑卒中量表(NIHSS)进行评估。主要结局为住院期间神经症状的变化(ΔNIHSS=出院时 NIHSS 评分-入院时 NIHSS 评分)。使用多元线性回归分析,并在调整以下混杂因素后采用逆概率处理加权法进行分析:治疗开始时的年龄、性别和收缩压及舒张压、入院时 NIHSS 评分、发病至入院时间、梗死灶大小、合并症、伴随药物治疗、临床科室、吸烟史、饮酒史和脑卒中史。结果-在调整潜在混杂因素后,与未用依达拉奉组相比,所有缺血性脑卒中亚型的依达拉奉治疗组入院至出院 NIHSS 评分的改善更大(ΔNIHSS 的平均[95%CI]差值:大动脉粥样硬化为-0.46[-0.75 至-0.16],心源性栓塞为-0.64[-1.09 至-0.2],小血管闭塞为-0.25[-0.4 至-0.09])。结论-对于任何缺血性脑卒中亚型,与未使用依达拉奉相比,使用依达拉奉(与未使用相比)与神经症状的更大改善相关,尽管差异较小(NIHSS 评分<1 分),且具有有限的临床意义。

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