氫水治療肌肉病的雙盲對照臨床試驗研究 #氫水 #日本研究
本研究的亮點：採用隨機、雙盲、安慰劑對照，觀察了氫氣水對患者線粒體和炎症肌病（肌肉營養不良）的治療效果。
分子氫氣具有許多神奇的效應，超過30多種動物疾病模型中發現氫氣具有治療氧化應激相關疾病的作用。更重要的是，在臨床研究中，人們發現氫氣對人類二型糖尿病、血液透析、代謝綜合征、肝癌放射治療的損傷、腦幹中風具有顯著治療效果。
氫氣治療疾病的細胞學機制被認為是通過清除羥基自由基、過氧亞硝酸根這樣具有強大氧化作用的自由基（不影響溫和的過氧化氫等），而且氫氣也可以影響細胞內信號系統。但是目前人們對氫氣生物效應的分子細節仍不清楚（這裡確實是一個非常令人值得期待的研究方向）。
氫氣是一個具有生物安全性的分子，人體內不停產生，到目前幾乎沒有任何明顯不良作用被發現。
因此氫氣相關藥物可能成為一類令人神往的臨床應用藥物。本文是第一個氫氣醫學領域的雙盲隨機對照研究。
先開展的開放性試驗（試探性研究）中讓進行性肌肉營養不良（進行性肌萎縮）患者每天飲1升富氫氣水，連續12周。其中，4例患者為多發性肌炎-皮肌炎（似乎是自身免疫性疾病），5例患者為線粒體病。每四周檢測18類血清學指標和尿的人8-異前列腺素F2a（8-isoprostane是可以說明氧化損傷程度的指標）。在隨後的隨機、雙盲、安慰劑試驗中，有10例DM(肌病)和12例線粒體病患者，給患者連續8周（怎麼沒有用12周）0.5升富氫水（為什麼不是1升）或普通水（安慰劑），每4周檢測18類血清指標。
研究結果：在該開放性研究（患者和醫生瞭解治療情況的研究）中，沒有發現臨床症狀的加重或減輕。但是，發現氫氣在肌肉病患者中乳糖/丙酮酸比例，餐後血糖，血清MMP3和血清甘油三脂具有顯著影響。
在雙盲試驗中，也沒有發現明顯的臨床效果，但DM患者的乳糖/丙酮酸比例，和MM患者的血清MMP3仍明顯改變，儘管沒有統計學差異。沒有在糖尿病患者中發現任何不良效應。
結論：氫水MM患者的對線粒體功能和PM/DM患者的炎症反應過程具有治療效果，但雙盲試驗中效果較差的原因可能是劑量比較小和觀察時間比較短（為什麼不增加劑量，延長觀察時間？）。但也說明氫氣的效果存在一個最低有效劑量（意思是說不能喝太少，至少要1升，有廣告嫌疑），而且有劑量效應（更確認效果的可靠性）。
We purchased 500 ml HEW or placebo water in aluminum pouch from Blue Mercury Inc. (Tokyo, Japan). We measured hydrogen concentrations using an H2-N hydrogen needle sensor attached to a PA2000 2-Channel Picoammeter (Unisense Science, Aarhus, Denmark). The hydrogen concentrations were ~0.5 ppm (~31% saturation). We also confirmed that hydrogen in placebo water was undetectable with our system. For each trial, we instructed patients to evacuate the air from the pouch and to close a plastic cap tightly every time after they drink wate
研究中使用0.5ppm的溶氫水儲存於鋁箔包裝之中，並且告知受測者務必要細心確保包裝袋的密封真空，盡量不要有留存空氣。
Research
Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies
Mikako Ito, Tohru Ibi, Ko Sahashi, Masatoshi Ichihara, Masafumi Ito and Kinji Ohno
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Medical Gas Research 2011, 1:24 doi:10.1186/2045-9912-1-24
Published: 3 October 2011
Abstract (provisional)
Background
Molecular hydrogen has prominent effects on more than 30 animal models especially of oxidative stress-mediated diseases and inflammatory diseases. In addition, hydrogen effects on humans have been reported in diabetes mellitus type 2, hemodialysis, metabolic syndrome, radiotherapy for liver cancer, and brain stem infarction. Hydrogen effects are ascribed to specific radical-scavenging activities that eliminate hydroxyl radical and peroxynitrite, and also to signal-modulating activities, but the detailed molecular mechanisms still remain elusive. Hydrogen is a safe molecule that is largely produced by intestinal bacteria in rodents and humans, and no adverse effects have been documented.
Methods
We performed open-label trial of drinking 1.0 liter per day of hydrogen-enriched water for 12 weeks in five patients with progressive muscular dystrophy (PMD), four patients with polymyositis/dermatomyositis (PM/DM), and five patients with mitochondrial myopathies (MM), and measured 18 serum parameters as well as urinary 8-isoprostane every 4 weeks. We next conducted randomized, double-blind, placebo-controlled, crossover trial of 0.5 liter per day of hydrogen-enriched water or placebo water for 8 weeks in 10 patients with DM and 12 patients with MM, and measured 18 serum parameters every 4 weeks.
Results
In the open-label trial, no objective improvement or worsening of clinical symptoms was observed. We, however, observed significant effects in lactate-to-pyruvate ratios in PMD and MM, fasting blood glucose in PMD, serum matrix metalloproteinase-3 (MMP3) in PM/DM, and serum triglycerides in PM/DM. In the double-blind trial, no objective clinical effects were observed, but a significant improvement was detected in lactate in MM. Lactate-to-pyruvate ratios in MM and MMP3 in DM also exhibited favorable responses but without statistical significance. No adverse effect was observed in either trial except for hypoglycemic episodes in an insulin-treated MELAS patient, which subsided by reducing the insulin dose.
Conclusions
Hydrogen-enriched water improves mitochondrial dysfunction in MM and inflammatory processes in PM/DM. Less prominent effects with the double-blind trial compared to the open-label trial were likely due to a lower amount of administered hydrogen and a shorter observation period, which implies a threshold effect or a dose-response effect of hydrogen.
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The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
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原文出處：http://www.medicalgasresearch.com/content/pdf/2045-9912-1-24.pdf
引用文獻：http://blog.sciencenet.cn/blog-41174-494659.html
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