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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日本将用大规模双盲随机临床研究证明氢气对蛛血疗效

已有 4095 次阅读 2014-9-10 20:53 |个人分类:氢气医学临床|系统分类:论文交流

 自从2007年日本学者首次报道小剂量氢气生物学效应以来,国际上众多基础和临床医学学者开展了大量动物实验和少量小规模临床研究,基础研究表明氢气对多种氧化损伤和炎症相关疾病具有潜在治疗作用,初步临床研究发现氢气水对类风湿关节炎、恶性肿瘤放疗副作用、脑干缺血、帕金森病、运动后疲劳、代谢综合症等具有治疗作用。按照药物研究的习惯,确定临床治疗效果一般需要超过300人规模的临床安慰剂双盲随机对照研究结果。按照这样的标准,目前还没有氢气对任何疾病有确定的临床证据。不过现在情况发生了改变,来自日本国防医学院的一项大规模临床安慰剂双盲随机对照研究计划将要证明,氢气水和硫化镁联合连续14天注射,对脑血管瘤破裂引起的蛛网膜下腔出血是否具有确切治疗效果,和单纯颅内注射硫酸镁对照组相比,联合静脉注射氢气生理盐水组效果是否明确,这一研究如果成功,将不仅给蛛网膜下腔出血治疗带来了新的治疗模式,而且可能是首次给氢气临床治疗效果提供了明确依据,这一研究必然会成为氢气医学研究历史上的重要文献。该研究方案99日发表在BMC Neurol上。

b本来以为这是一个研究报道,阅读全文后发现,这只是一个研究方案,没有研究结果,这也可以发表论文?看来发表论文完全不需要研究就可以。



BMCNeurol. 2014 Sep 9;14(1):176. [Epub ahead of print]

Effectsof intravenous infusion of hydrogen-rich fluid combined with intra-cisternalinfusion of magnesium sulfate in severe aneurysmal subarachnoid hemorrhage:study protocol for a randomized controlled trial.

TakeuchiS, Mori K, Arimoto H, Fujii K, Nagatani K, Tomura S, Otani N, Osada H, Wada K.

BackgroundThefailures of recent studies intended to prevent cerebral vasospasm have movedthe focus of research into delayed cerebral ischemia away from cerebral arteryconstriction towards other mechanisms. Recent accumulating evidence hassuggested that early brain injury is also involved in the development ofdelayed cerebral ischemia, and that hydrogen can prevent early brain injury.Therefore, we have established a combination therapy of intravenous hydrogeninfusion and intra-cisternal magnesium sulfate infusion for the treatment ofboth early brain injury and cerebral vasospasm. The present randomizedcontrolled clinical trial is designed to investigate the effects of this noveltherapeutic strategy on the occurrence of cerebral vasospasm, delayed cerebralischemia, and clinical outcomes after high-grade subarachnoidhemorrhage.MethodsThis study is a randomized, double-blind, placebo-controlleddesign to be conducted in two hospitals. A total of 450 patients withhigh-grade subarachnoid hemorrhage will be randomized to one of three arms: (i)Mg¿+¿H2 group, (ii) Mg group, and (iii) control group. Patients who areassigned to the Mg¿+¿H2 group will receive intra-cisternal magnesium sulfateinfusion (2.5 mmol/L) at 20 mL/h for 14 days and intravenous hydrogen-richfluid infusion (200 mL) twice a day for 14 days. Patients who are assigned tothe Mg group will receive intra-cisternal magnesium sulfate infusion (2.5mmol/L) at 20 mL/h for 14 days and intravenous normal glucose-electrolytesolution (200 mL) without added hydrogen twice a day for 14 days. Patients whoare assigned to the control group will receive intra-cisternal Ringer solutionwithout magnesium sulfate at 20 mL/h for 14 days and intravenous normalglucose-electrolyte solution (200 mL) without added hydrogen twice a day for 14days. Primary outcome measures will be occurrence of delayed cerebral ischemiaand cerebral vasospasm. Secondary outcome measures will be modified Rankinscale score at 3, 6, and 12 months and biochemical markers.DiscussionThepresent protocol for a randomized, placebo-controlled study of intravenoushydrogen therapy with intra-cisternal magnesium infusion is expected toestablish the efficacy and safety of this therapeutic strategy.TrialregistrationUMIN-CTR: UMIN000014696.

日本脑出血氢气试验计划.pdf




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