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米诺环素治疗急性缺血性脑卒中的疗效:一项单盲、安慰剂对照试验。

Efficacy of minocycline in acute ischemic stroke: a single-blinded, placebo-controlled trial.

机构信息

Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Neurol India. 2012 Jan-Feb;60(1):23-8. doi: 10.4103/0028-3886.93584.

Abstract

BACKGROUND

Minocycline is a semisynthetic derivative of the tetracycline group of antibiotics, which have neuroprotective effects. In animal stroke models, minocycline had shown promising evidence to improve clinical and functional outcomes.

OBJECTIVE

To analyze the effect of oral minocycline in acute ischemic stroke patients.

MATERIALS AND METHODS

This was a randomized single-blinded open-label study. The study group received oral minocycline 200 mg/day for 5 days and the control group received oral vitamin B capsules. Baseline assessment included the following: National Institute of Health Stroke Scale (NIHSS) score, modified Barthel Index (mBI), modified Rankin Scale (mRS) score, Magnetic Resonance Imaging (MRI) of brain including Diffusion Weighted Imaging (DWI), chest X-ray, and routine laboratory investigations. The clinical scales were repeated at days 1, 7, and 30. The end point was outcomes at 3 months (90 days). Statistical analysis was done with SPSS 11.5 (P<0.05). Paired t-test and multiple-measures Analysis Of Variance (ANOVA) were used.

RESULTS

Fifty patients with acute ischemic stroke were included in the study. Of these, 23 patients received minocycline and 27 patients received placebo i.e., vitamin B capsules. NIHSS score in patients receiving minocycline had shown statistically significant improvement at day 30 and 90 as compared with the controls. Similarly, mRS scores and BI showed significant improvement in patients receiving minocycline at three months as compared to the control group. No mortality, myocardial infarctions, recurrent strokes, and hemorrhagic transformations were noted in both groups.

CONCLUSIONS

Patients with acute ischemic stroke had significantly better outcome with minocycline treatment as compared with those administered placebo. The above findings suggest that minocycline can be helpful in reducing the clinical deficits after acute ischemic stroke.

摘要

背景

米诺环素是一种半合成的四环素类抗生素衍生物,具有神经保护作用。在动物中风模型中,米诺环素已显示出改善临床和功能结局的有希望的证据。

目的

分析口服米诺环素对急性缺血性脑卒中患者的影响。

材料和方法

这是一项随机、单盲、开放标签的研究。研究组接受米诺环素 200mg/天,共 5 天,对照组接受口服维生素 B 胶囊。基线评估包括以下内容:国立卫生研究院卒中量表(NIHSS)评分、改良巴氏指数(mBI)、改良 Rankin 量表(mRS)评分、脑磁共振成像(MRI),包括弥散加权成像(DWI)、胸部 X 射线和常规实验室检查。临床量表在第 1、7 和 30 天重复。终点为 3 个月(90 天)的结局。使用 SPSS 11.5 进行统计分析(P<0.05)。采用配对 t 检验和多变量方差分析(ANOVA)进行分析。

结果

本研究纳入了 50 例急性缺血性脑卒中患者。其中,23 例患者接受米诺环素治疗,27 例患者接受安慰剂,即维生素 B 胶囊。与对照组相比,接受米诺环素治疗的患者 NIHSS 评分在第 30 天和第 90 天有统计学显著改善。同样,接受米诺环素治疗的患者 mRS 评分和 BI 在 3 个月时也明显优于对照组。两组均未发生死亡、心肌梗死、复发性中风和出血性转化。

结论

与安慰剂相比,急性缺血性脑卒中患者接受米诺环素治疗的临床结局明显更好。上述发现表明,米诺环素有助于减轻急性缺血性中风后的临床缺陷。

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