氢分子医学分享 http://blog.sciencenet.cn/u/孙学军 对氢气生物学效应感兴趣者。可合作研究:sunxjk@hotmail.com 微信 hydrogen_thinker

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静脉射氢气注射液治疗脑缺血患者的安全性

已有 3200 次阅读 2013-6-26 21:39 |个人分类:氢气生理盐水|系统分类:论文交流|关键词:注射液,安全性| 安全性, 注射液

氢气的重要生物学效应是用脑缺血动物模型确定的,但目前除有少数脑干缺血的临床报道外,并没有数量较的临床研究。

最近来自日本国防医科大学神经外科的学者的一篇关于氢气治疗中风的临床研究报道,在线发表在《医学气体研究》上,研究由三家医院共同完成,共有38名临床不同程度的脑缺血患者,每天注射氢气饱和的葡萄糖溶液200毫升,同时联合使用衣达拉丰,部分患者进行了(t-PA)溶栓治疗,在治疗3天、7天和90天后分别观察了血液生化、尿液、脑点图、胸部x线片,并观察了血液MDA含量,38例患者中有1例因心衰死亡,1例出现腹泻,其余没有观察到异常。研究结果提示,静脉注射氢气溶液对中风,包括经溶栓治疗的患者是安全的。遗憾地是,由于研究缺乏对照组,因此无法确定这种治疗是否有临床意义。

免费全文:The complete article is availableas a provisional PDF.The fully formatted PDFand HTML versions are in production.

Safety of intravenous administration of hydrogen-enrichedfluid in patients with acute cerebral ischemia: initial clinical studies

Kimihiro Nagatani, Hiroshi Nawashiro, Satoru Takeuchi, Satoshi Tomura,Naoki Otani, Hideo Osada, Kojiro Wada, Hiroshi Katoh,Nobusuke Tsuzuki and Kentaro Mori  

Background

Most of the results regarding hydrogen (H2) therapy foracute cerebral ischemia are derived from in vitro studies and animalexperiments, with only a few obtained from human trials with a limited numberof subjects. Thus, there is a paucity of information regarding both thebeneficial therapeutic effects as well as the side effects of H2 on acutecerebral ischemia in humans. We designed a pilot study to investigate singledose intravenous H2-administration in combination with edaravone, aiming toprovide an initial estimate of the possible risks and benefits in selectpatients presenting with acute ischemic stroke.

MethodsAn open-label, prospective, non-randomized study of intravenousH2-administration was performed in 38 patients hospitalized for acute ischemicstroke. All patients received an H2-enriched intravenous solution in additionto edaravone immediately after the diagnosis of acute ischemic stroke. Acutestroke patients within 3 h of onset received intravenous tissue plasminogenactivator (t-PA) (0.6 mg/kg) treatment, and patients receiving t-PA had tocommence the administration of the H2-enriched intravenous solution andedaravone before or at the same time as the t-PA was infused.

Results Complications wereobserved in 2 patients (5.3%), which consisted of diarrhea in 1 patient (2.6%)and cardiac failure in 1 patient (2.6%). No deterioration in laboratory tests,urinary tests, ECG, or chest X-ray radiograms occurred in any patient in thisstudy. In all patients, the mean National Institutes of Health Stroke Scale(NIHSS) scores at baseline, and 7, 30, and 90 d after admission were 8.2 +/-7.5, 5.6 +/- 7.1, 4.9 +/- 6.5, and 4.5 +/- 6.3, respectively. The earlyrecanalization was identified in 4 of 11 patients (36.4%) who receivedintravenous t-PA administration. Hemorrhagic transformation was observed in 2patients (18.2%). None of the patients in this study that were treated witht-PA developed symptomatic intracranial hemorrhage.

Conclusions Data from thecurrent study indicate that an H2-enriched intravenous solution is safe forpatients with acute cerebral infarction, including patients treated with t-PA.




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