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TALOS:一项多中心、随机、双盲、安慰剂对照试验,旨在测试西酞普兰对急性中风患者的疗效。

TALOS: a multicenter, randomized, double-blind, placebo-controlled trial to test the effects of citalopram in patients with acute stroke.

作者信息

Kraglund Kristian Lundsgaard, Mortensen Janne Kaergaard, Grove Erik Lerkevang, Johnsen Søren Paaske, Andersen Grethe

机构信息

Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

出版信息

Int J Stroke. 2015 Aug;10(6):985-7. doi: 10.1111/ijs.12485. Epub 2015 Apr 8.

DOI:10.1111/ijs.12485
PMID:25854537
Abstract

RATIONALE

Selective Serotonin Reuptake Inhibitors (SSRI) are effective in the treatment of post-stroke depression and may have potential neuroprotective and vascular effects. Data from registry studies have further indicated a protective effect against recurrent ischemic events, but also an increased risk of bleeding in patients with ischemic stroke. Therefore, prospective studies are needed to determine the effects of SSRI treatment after acute ischemic stroke.

AIMS AND DESIGN

TALOS is an investigator-initiated, national multicenter randomized- and placebo-controlled, double-blind trial testing citalopram in acute ischemic stroke. We hypothesize that citalopram treatment initiated in the acute phase after ischemic stroke will improve outcome assessed by the modified Rankin Score (mRS) and reduce the risk of death from vascular causes, transient ischemic attack (TIA)/stroke and myocardial infarction.

STUDY OUTCOMES

There are two co-primary effect variables: (i) Functional status at six-months, measured by the modified Rankin Scale, and (ii) Vascular death, TIA/stroke and myocardial infarction. Secondary effect variables include: (i) Single primary outcomes; (ii) The Barthel Index; (iii) Mini Mental State Examination at six-months; (iv) Final infarct size (Magnetic Resonance Imaging).

DISCUSSION

SSRI treatment is well tolerated and overall beneficial in the wake of stroke; it may also be neuroprotective and prevent new vascular events.

摘要

理论依据

选择性5-羟色胺再摄取抑制剂(SSRI)在治疗中风后抑郁症方面有效,且可能具有潜在的神经保护和血管效应。登记研究的数据进一步表明其对复发性缺血事件有保护作用,但缺血性中风患者出血风险也会增加。因此,需要进行前瞻性研究以确定急性缺血性中风后SSRI治疗的效果。

目的与设计

TALOS是一项由研究者发起的、全国多中心随机、安慰剂对照、双盲试验,在急性缺血性中风中测试西酞普兰。我们假设在缺血性中风急性期开始使用西酞普兰治疗将改善通过改良Rankin量表(mRS)评估的预后,并降低血管性原因导致的死亡、短暂性脑缺血发作(TIA)/中风和心肌梗死的风险。

研究结果

有两个共同主要效应变量:(i)六个月时的功能状态,通过改良Rankin量表测量;(ii)血管性死亡、TIA/中风和心肌梗死。次要效应变量包括:(i)单一主要结局;(ii)Barthel指数;(iii)六个月时的简易精神状态检查;(iv)最终梗死灶大小(磁共振成像)。

讨论

SSRI治疗耐受性良好,中风后总体有益;它也可能具有神经保护作用并预防新的血管事件。

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