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米诺环素对缺血性中风神经保护作用的开放标签、评估者盲法临床研究:性别依赖性效应

An open-label evaluator-blinded clinical study of minocycline neuroprotection in ischemic stroke: gender-dependent effect.

作者信息

Amiri-Nikpour Mohammad Reza, Nazarbaghi Surena, Hamdi-Holasou Milad, Rezaei Yousef

机构信息

Department of Neurology, Imam Khomeini Hospital, Urmia University of Medical Sciences, Urmia, Iran.

出版信息

Acta Neurol Scand. 2015 Jan;131(1):45-50. doi: 10.1111/ane.12296. Epub 2014 Aug 23.

Abstract

OBJECTIVES

Minocycline as an antibiotic has been found to have neuroprotective effect on neurodegenerative diseases. This study was aimed at determining the efficacy of minocycline adjunct to aspirin in improving neurological outcomes of ischemic stroke during 3-month follow-up.

METHODS AND MATERIALS

In an open-label evaluator-blinded trial, 60 patients with ischemic stroke were allocated into two groups to receive either 200 mg of oral minocycline daily for 5 days during 6-24 h following onset of signs and symptoms, or not receiving any, as control; all patients also received 100 mg of aspirin daily. Clinical assessment at baseline and on days 30, 60, and 90 was performed using National Institutes of Health Stroke Scale (NIHSS) score.

RESULTS

Fifty-three patients (88.3%) completed the study. Females in the treatment and control groups were 53.8% and 51.9%, respectively (P = 0.884). Among all patients, NIHSS score was significantly lower in the minocycline-treated compared with control on day 90 (minocycline median 4, interquartile range 4-7, control median 7, interquartile range 5-8, P = 0.031). Among males, NIHSS was lower in minocycline-treated compared with controls on days 30, 60, and 90 (P < 0.05); however, females showed no significant differences at the same times compared with controls. No adverse outcomes including myocardial infarction, recurrent stroke, and mortality were observed in the both groups.

CONCLUSION

Patients with ischemic stroke who received oral minocycline daily for 5 days had significantly better neurological outcomes on day 90 than controls. However, females showed no significant clinical improvement compared to males.

摘要

目的

已发现米诺环素作为一种抗生素对神经退行性疾病具有神经保护作用。本研究旨在确定米诺环素联合阿司匹林在3个月随访期间改善缺血性中风神经功能结局的疗效。

方法和材料

在一项开放标签、评估者盲法试验中,60例缺血性中风患者被分为两组,一组在症状和体征出现后6 - 24小时内每天口服200毫克米诺环素,共5天,另一组不接受任何治疗作为对照;所有患者还每天服用100毫克阿司匹林。使用美国国立卫生研究院卒中量表(NIHSS)评分在基线以及第30、60和90天进行临床评估。

结果

53例患者(88.3%)完成了研究。治疗组和对照组的女性分别占53.8%和51.9%(P = 0.884)。在所有患者中,与对照组相比,米诺环素治疗组在第90天的NIHSS评分显著更低(米诺环素组中位数为4,四分位间距为4 - 7,对照组中位数为7,四分位间距为5 - 8,P = 0.031)。在男性中,米诺环素治疗组在第30、60和90天的NIHSS评分低于对照组(P < 0.05);然而,女性在相同时间与对照组相比无显著差异。两组均未观察到包括心肌梗死、复发性中风和死亡在内的不良结局。

结论

每天口服米诺环素5天的缺血性中风患者在第90天的神经功能结局明显优于对照组。然而,与男性相比,女性未显示出显著的临床改善。

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