氢气生理盐水注射的临床研究

有时候科学研究要采用非常规手段，关于氢气生物学效应的研究，动物试验可以用注射生理盐水，但一直以来大家都采用饮用氢气水观察临床疾病的效果，而且进展不快。由于饮水作为一种手段，存在吸收慢，剂量不准确，效果不理想等缺陷。采用注射的方法一直是我们的一种希望。

关于注射氢气生理盐水，我们一直不敢去作，主要的原因是氢气生理盐水没有获得临床使用的许可，我过去估计将来用到临床上要有许多的前期工作。首先要做大量动物试验证明效果，然后根据动物试验申请临床前试验，例如毒性试验等。尽管氢气本身的安全性不容置疑，但含氢气盐水没有获得临床批准的情况下，一直是我们做这方面研究的一个梦想。

后来与一些制药公司谈这个事情，但大家对氢气盐水并不太有兴趣，主要是因为这个“药”太简单，将来即使研究成功，价钱也不太高，就不能挣大钱，制药公司对利润有兴趣，并不对效果本身有兴趣，有效果没有利润的药物是没有兴趣的。这个情况给我们的打击是很大的，从研究者的角度考虑，一个价钱便宜，效果理想的药物才应该大家追求的目标，但这个目标一旦遇到市场，就成了一个障碍。

最近日本学者给这个问题提供了一个可行的选择方案。他们是把临床上使用的注射液，在不打开包装的情况下，利用氢气的良好扩散性能，选择有良好透气性的注射液包装，把氢气逐渐扩散到注射液，成功制备出合法的氢气生理盐水注射液。当然这种方法是否是属于擦边球，但毕竟躲开了上述制约因素，也许就成为将来氢气注射液的一种规范。这个研究论文是我负责邀请审稿人，当时我看了就觉得是一个难得的好思路，由于没有正式发表，就没有对内容进行详细公布。现在这个文章正式刊用，我在第一时间介绍给大家。

因此我觉得，进行科学研究有时候也需要一些“旁门左道”，这也是一种创新的形式。

建议开展氢气生物学研究的人认真阅读这个文章，特别是目前希望开展临床研究的，应该好好借鉴这个思路。

氢气生理盐水注射的临床研究

本文全文：http://www.medicalgasresearch.com/content/1/1/11/abstract

Case report

Improved brain MRI indices in the acute brain stem infarct sites treated with hydroxyl radical scavengers, Edaravone and hydrogen, as compared to Edaravone alone. A non-controlled study.

Hirohisa Ono, Yoji Nishijima, Naoto Adachi, Shigekuni Tachibana, Shiroh Chitoku, Shigeo Mukaihara, Masaki Sakamoto, Yohei Kudo, Jun Nakazawa, Kumi Kaneko and Hiroshi Nawashiro

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Medical Gas Research 2011, 1:12 doi:10.1186/2045-9912-1-12

Published: 7 June 2011

Abstract (provisional)

Background

In acute stage of cerebral infarction, MRI indices (rDWI & rADC) deteriorate during the first 3-7 days after the ictus and then gradually normalize in approximately 10 days (pseudonormalization time), although the tissue is already infarcted. Since effective treatments improve these indices significantly and in less than the natural pseudonormalization time, a combined analysis of these changes provides an opportunity for objective evaluation on the effectiveness of various treatments for cerebral infarction. Hydroxyl radicals are highly destructive to the tissue and aggravate cerebral infarction. We treated brainstem infarction patients in acute stage with hydroxyl radical scavengers (Edaravone and hydrogen) by intravenous administration and evaluated the effects of the treatment by a serial observation and analysis of these MRI indices. The effects of the treatment were evaluated and compared in two groups, an Edaravone alone group and a combined group with Edaravone and hydrogen, in order to assess beneficial effects of addition of hydrogen.

Methods

The patients were divided in Edaravone only group (E group. 26 patients) and combined treatment group with Edaravone and hydrogen enriched saline (EH group. 8 patients). The extent of the initial hump of rDWI , the initial dip of rADC and pseudo- normalization time were determined in each patient serially and averages of these data were compared in these two groups and also with the natural course in the literatures.

Results

The initial hump of rDWI reached 2.0 in the E group which was better than 2.5 of the natural course but was not as good as 1.5 of the EH group. The initial dip of rADC was 0.6 in the E group which was close to the natural course but worse than 0.8 of the EH group. Pseudonormalization time of rDWI and rADC was 9 days only in EH group but longer in other groups. Addition of hydrogen caused no side effects.

Conclusions

Administration of hydroxyl radical scavengers in acute stage of brainstem infarction improved MRI indices against the natural course. The effects were more obvious and significant in the EH group. These findings may imply the need for more frequent daily administration of hydroxyl scavenger, or possible additional hydrogen effects on scavenger mechanisms.