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西酞普兰对急性缺血性卒中结局的疗效:一项随机临床试验。

Efficacy of Citalopram on Acute Ischemic Stroke Outcome: A Randomized Clinical Trial.

作者信息

Savadi Oskouie Daryoush, Sharifipour Ehsan, Sadeghi Bazargani Homayoun, Hashemilar Mazyar, Nikanfar Masoud, Ghazanfari Amlashi Saeed, Abbaszade Zahra, Sadeghihokmabadi Elyar, Rikhtegar Reza, Golzari Samad E J

机构信息

1 Tabriz University of Medical Sciences, Razi Hospital, Tabriz, Iran.

2 Qom University of Medical Sciences, Iran.

出版信息

Neurorehabil Neural Repair. 2017 Jul;31(7):638-647. doi: 10.1177/1545968317704902. Epub 2017 Apr 28.

Abstract

BACKGROUND AND PURPOSE

Ischemic stroke (IS) is one of the main causes of death and disability in the adult population, and recovery from it is a major health concern worldwide. The aim of the present study was to evaluate the effectiveness of citalopram on 3-mounth outcome of nondepressed acute IS patients.

METHODS

In a randomized, placebo-controlled clinical trial, 144 patients with acute IS were studied for 3 months. In one group, the patients received oral citalopram 20 mg (once daily), and in the other group, they received placebo. All patients received standard care, including physiotherapy. Patients with depression were excluded throughout the study. The primary outcome of the study was set to a 50% reduction in the 3-month National Institutes of Health Stroke Scale compared with the baseline scores (Clinical Trial Registration URL: http://www.irct.ir ; Unique identifier: IRCT201203192150N2).

RESULTS

The mean age of patients was 66.4 years. Of 144 eligible patients, 15 patients died (4 in the citalopram and 11 in the placebo group), and 21 patients did not complete the study follow-up period (10 in the citalopram and 11 in the placebo group). The primary outcome of the study was achieved in 57 patients (79%) in the citalopram and 39 patients (54%) in the placebo group ( P < .001), with risk ratio and number needed to treat of 2 (CI = 1.2-3) and 4 (CI = 2.5-8.6), respectively. No major adverse events were found in either group.

CONCLUSIONS

Citalopram is a safe and tolerable medication in patients with acute IS, which could improve the outcome in these patients.

摘要

背景与目的

缺血性卒中(IS)是成年人群死亡和残疾的主要原因之一,其恢复情况是全球主要的健康关注点。本研究旨在评估西酞普兰对非抑郁急性缺血性卒中患者3个月预后的有效性。

方法

在一项随机、安慰剂对照临床试验中,对144例急性缺血性卒中患者进行了3个月的研究。一组患者口服20毫克西酞普兰(每日一次),另一组患者接受安慰剂。所有患者均接受包括物理治疗在内的标准护理。在整个研究过程中排除了抑郁症患者。研究的主要结局设定为与基线评分相比,3个月时美国国立卫生研究院卒中量表评分降低50%(临床试验注册网址:http://www.irct.ir;唯一标识符:IRCT201203192150N2)。

结果

患者的平均年龄为66.4岁。在144例符合条件的患者中,15例死亡(西酞普兰组4例,安慰剂组11例),21例患者未完成研究随访期(西酞普兰组10例,安慰剂组11例)。西酞普兰组57例患者(79%)达到了研究的主要结局,安慰剂组39例患者(54%)达到了主要结局(P <.001),风险比和需治疗人数分别为2(CI = 1.2 - 3)和4(CI = 2.5 - 8.6)。两组均未发现重大不良事件。

结论

西酞普兰对急性缺血性卒中患者是一种安全且可耐受的药物,可改善这些患者的预后。

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