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氢气吸入治疗急性脑梗死:一项关于安全性和神经保护作用的随机对照临床研究

Hydrogen Gas Inhalation Treatment in Acute Cerebral Infarction: A Randomized Controlled Clinical Study on Safety and Neuroprotection.

作者信息

Ono Hirohisa, Nishijima Yoji, Ohta Shigeo, Sakamoto Masaki, Kinone Kazunori, Horikosi Tohru, Tamaki Mituyuki, Takeshita Hirosi, Futatuki Tomoko, Ohishi Wataru, Ishiguro Taichi, Okamoto Saori, Ishii Shou, Takanami Hiroko

机构信息

Department of Neurosurgery, Nishijima Hospital, Numazu-city, Shizuoka-ken, Japan.

Department of Neurosurgery, Nishijima Hospital, Numazu-city, Shizuoka-ken, Japan.

出版信息

J Stroke Cerebrovasc Dis. 2017 Nov;26(11):2587-2594. doi: 10.1016/j.jstrokecerebrovasdis.2017.06.012. Epub 2017 Jun 29.

Abstract

BACKGROUND

Molecular hydrogen (H) acts as a therapeutic antioxidant. Inhalation of H gas (1-4%) was effective for the improvement of cerebral infarction in multiple animal experiments. Thus, for actual applications, a randomized controlled clinical study is desired to evaluate the effects of inhalation of H gas. Here, we evaluate the H treatment on acute cerebral infarction.

METHODS

Through this randomized controlled clinical study, we assessed the safety and effectiveness of H treatment in patients with cerebral infarction in an acute stage with mild- to moderate-severity National Institute of Health Stroke Scale (NIHSS) scores (NIHSS = 2-6). We enrolled 50 patients (25 each in the H group and the control group) with a therapeutic time window of 6 to 24 hours. The H group inhaled 3% H gas (1 hour twice a day), and the control group received conventional intravenous medications for the initial 7 days. The evaluations included daily vital signs, NIHSS scores, physical therapy indices, weekly blood chemistry, and brain magnetic resonance imaging (MRI) scans over the 2-week study period.

RESULTS

The H group showed no significant adverse effects with improvements in oxygen saturation. The following significant effects were found: the relative signal intensity of MRI, which indicated the severity of the infarction site, NIHSS scores for clinically quantifying stroke severity, and physical therapy evaluation, as judged by the Barthel Index.

CONCLUSIONS

H treatment was safe and effective in patients with acute cerebral infarction. These results suggested a potential for widespread and general application of H gas.

摘要

背景

分子氢(H₂)具有治疗性抗氧化作用。在多项动物实验中,吸入氢气(1%-4%)对改善脑梗死有效。因此,在实际应用中,需要进行随机对照临床研究来评估吸入氢气的效果。在此,我们评估氢气治疗急性脑梗死的效果。

方法

通过这项随机对照临床研究,我们评估了氢气治疗对急性期脑梗死患者的安全性和有效性,这些患者的美国国立卫生研究院卒中量表(NIHSS)评分为轻度至中度(NIHSS = 2-6)。我们纳入了50例患者(氢气组和对照组各25例),治疗时间窗为6至24小时。氢气组吸入3%的氢气(每天两次,每次1小时),对照组在最初7天接受常规静脉药物治疗。评估内容包括每日生命体征、NIHSS评分、物理治疗指标、每周血液生化检查以及为期2周的研究期间的脑磁共振成像(MRI)扫描。

结果

氢气组未显示出明显不良反应,且氧饱和度有所改善。发现了以下显著效果:MRI的相对信号强度(表明梗死部位的严重程度)、用于临床量化卒中严重程度的NIHSS评分以及由巴氏指数判断的物理治疗评估。

结论

氢气治疗对急性脑梗死患者安全有效。这些结果表明氢气具有广泛普遍应用的潜力。

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