氫醫(yī)學(xué)已經(jīng)走過(guò)了漫長(zhǎng)而崎嶇的道路。從1975年在《科學(xué)》上發(fā)表第一個(gè)研究論文，到2007年《自然醫(yī)學(xué)》上發(fā)表微量吸入氫氣具有疾病治療作用的奠基性研究，大量研究論文報(bào)道氫氣對(duì)不同的疾病和損傷具有治療作用。但是氫氣目前并沒(méi)有進(jìn)入主流醫(yī)療實(shí)踐，仍然徘徊在正規(guī)醫(yī)療手段之外游蕩。氫氣是有前景的醫(yī)療工具，但主要因?yàn)闅錃獾挠行院桶踩匀狈ψ銐驈?qiáng)的臨床研究證據(jù)，無(wú)法獲得藥物監(jiān)管部門(如FDA)批準(zhǔn)用于臨床疾病治療。 足夠強(qiáng)的有效性安全性證據(jù)，主要是指符合標(biāo)準(zhǔn)的雙盲安慰劑隨機(jī)對(duì)照臨床試驗(yàn)數(shù)據(jù)。最近幾年高質(zhì)量氫氣治療疾病臨床試驗(yàn)注冊(cè)數(shù)據(jù)快速增加，給氫氣的臨床應(yīng)用提供了讓人期待的愿景。氫氣醫(yī)學(xué)著名論文寫手塞爾維亞Sergej M. Ostojic教授對(duì)這些氫氣醫(yī)學(xué)臨床數(shù)據(jù)進(jìn)行了整理，給大家了相關(guān)數(shù)據(jù)提供了方便。 
從2015年11月到2019年2月期間在ClinicalTrials.gov注冊(cè)的氫氣醫(yī)學(xué)臨床數(shù)據(jù)，研究的疾病類型很多，有缺血性中風(fēng)、支氣管擴(kuò)張，也有實(shí)體腫瘤。氫氣的12項(xiàng)臨床試驗(yàn)分別來(lái)自美國(guó)、中國(guó)和其他國(guó)家。 根據(jù)國(guó)際疾病分類ICD-10.其中4項(xiàng)屬于呼吸系統(tǒng)疾病，3項(xiàng)屬于神經(jīng)系統(tǒng)疾病，2項(xiàng)屬于內(nèi)分泌/代謝性疾病。給氫氣的方法中7項(xiàng)是吸入氫氣，有4項(xiàng)是口服途徑攝取氫氣。4項(xiàng)研究是觀察氫氣聯(lián)合氧氣等復(fù)方效應(yīng)。 氫氣使用持續(xù)時(shí)間從3天到1年不等，大多數(shù)是3月。評(píng)價(jià)主要終點(diǎn)包括臨床效應(yīng)、實(shí)驗(yàn)室檢查和影像學(xué)數(shù)據(jù)。9項(xiàng)研究經(jīng)費(fèi)來(lái)自政府，2項(xiàng)來(lái)自私人企業(yè)，1項(xiàng)來(lái)自政府和私人機(jī)構(gòu)。 這些臨床研究說(shuō)明氫氣醫(yī)學(xué)已經(jīng)引起越來(lái)越多臨床學(xué)者的重視，希望通過(guò)系統(tǒng)可靠的臨床研究數(shù)據(jù)來(lái)證明氫氣的疾病治療效應(yīng)，這可能會(huì)推動(dòng)未來(lái)政府醫(yī)療保健政策對(duì)氫氣臨床應(yīng)用的支持。 但是毋庸置疑，氫氣的臨床研究仍然不夠多，注冊(cè)樣本量規(guī)模不夠大，這很難保證陽(yáng)性結(jié)果的獲得，也難以達(dá)到高質(zhì)量的結(jié)論。大多數(shù)研究只有一個(gè)研究者或?qū)儆谝粋�(gè)醫(yī)院或大學(xué)的研究小組(非多中心)。更最重要的是，沒(méi)有試驗(yàn)探討氫氣的藥物安全性。安全問(wèn)題雖然問(wèn)題不大，但對(duì)氫氣吸入等可能構(gòu)成的危險(xiǎn)風(fēng)險(xiǎn)必須進(jìn)行評(píng)估，只依靠經(jīng)典教科書數(shù)據(jù)并不能獲得藥物監(jiān)管機(jī)構(gòu)的認(rèn)可�？傊�，過(guò)去5年氫氣醫(yī)學(xué)臨床研究有增加，但在研究多樣化和開(kāi)拓性試驗(yàn)方面仍然不夠。氫氣健康產(chǎn)業(yè)是一個(gè)微利領(lǐng)域，難以支撐開(kāi)展高質(zhì)量大規(guī)模多中心臨床研究仍然是經(jīng)費(fèi)投入不足造成。從這些情況看，希望利用氫氣快速發(fā)財(cái)不是好路子，未來(lái)氫氣醫(yī)學(xué)需要依靠政府加大投入，需要依靠各種慈善機(jī)構(gòu)的贊助，才能維持好健康持續(xù)發(fā)展，因?yàn)闅錃忉t(yī)療概念雖然很新，但技術(shù)本身不屬于高科技，無(wú)法提供和承載高額技術(shù)紅利。 氫氣醫(yī)學(xué)研究需要有大型制藥公司參與，不僅需要大量臨床前動(dòng)物實(shí)驗(yàn)開(kāi)展效應(yīng)驗(yàn)證，也需要大量投入開(kāi)展多中心臨床研究。宇宙中最小，也是宇宙最古老的分子，現(xiàn)在竟然背負(fù)臨床試驗(yàn)這個(gè)沉重的十字架。 曙光乍現(xiàn)，期待成功。 特別感謝Sergej M. Ostojic博士提供的英文原文。 Table 1. List of selected recentand ongoing clinical trials using molecular hydrogen.
Condition or disease | First posted | n | Design | Phase | Intervention | Primary outcomes | Sponsor | Liver/ kidney transplantation | Nov 24. 2015 | 20 | RCT | Phase III | Lavage with hydrogen-rich celsior solution | Serum AST/ALT, DBil/ TBil, creatinine, GFR | RenJi Hospital | Bronchiectasis | May 6. 2016 | 120 | RCT | NA | Inhalation of hydrogen gas | Annual frequency of bronchiectasis exacerbations | Guangzhou Institute of Respiratory Disease | Cognitive impairments | Jul 13. 2016 | 13 | Open label | Phase III | Inhalation of hydrogen gas | ADAS-Cog total score | University of Novi Sad | Obesity | Jul 14. 2016 | 12 | RCT | Phase III | Molecular hydrogen tablet | Body fat percentage, serum insulin and ghrelin | Center for Health, Exercise and Sport Sciences, Serbia | COPD | Jul 29. 2016 | 140 | RCT | NA | Inhalation of hydrogen-oxygen mixture | Dyspnea index score | Shanghai Asclepius Meditec Inc. West China Hospital Second Affiliated Hospital of Guangzhou Medical University The Second Hospital of Hebei Medical University Tianjin Medical University General Hospital The First Affiliated Hospital of Guangzhou Medical University | Asthma | Aug 30. 2016 | 150 | RCT | NA | Inhalation of hydrogen-oxygen mixture | Mini Asthma Quality of life | Shanghai Asclepius Meditec Inc. The First Affiliated Hospital of Guangzhou Medical University Second Affiliated Hospital of Guangzhou Medical University The Second Hospital of Hebei Medical University Tianjin Medical University General Hospital West China Hospital | Chronic graft-versus-host disease | Sep 28. 2016 | 100 | Open label | Phase II | Drinking hydrogen-rich water | ORR, TTF, OS, toxicity | Navy General Hospital, Beijing | Tracheal stenosis | Nov 11. 2016 | 50 | RCT | NA | Inhalation of hydrogen-oxygen mixture | sRMSdi/para/sc, RMSdi, Pdi, MIP | Guangzhou Institute of Respiratory Disease | Ischemic stroke | Oct 24. 2017 | 100 | RCT | Phase II / III | Intravenous and oral hydrogen | Modified Rankin scale | Stony Brook University | Non-alcoholic fatty liver disease | Aug 10. 2018 | 10 | RCT | NA | Drinking hydrogen-rich water | Liver fat content, serum TC, TG | University of Novi Sad | Adult solid tumor | Jan 28. 2019 | 200 | RCT | NA | Inhalation of hydrogen-oxygen mixture | Sleep, diet and exercise quality, PFS, OS | Fuda Cancer Hospital, Guangzhou Shanghai Asclepius Meditech Co., Ltd | Exercise performance | Feb 19. 2019 | 20 | RCT | NA | Inhalation of hydrogen gas | Running time-to-exhaustion, MVIS | University of Novi Sad |
Abbreviations: RCT, randomizedcontrolled trial; AST, aspartate transaminase; ALT, alanine transaminase; DBil,direct bilirubin; Tbil, total bilirubin; GFR, glomerular filtration rate; ADAS-Cog,Alzheimer'sDisease Assessment Scale-cognitive subscale; COPD, chronic obstructivepulmonary disease; NA, not applicable; ORR, objective response rate; TTF, timeto treatment failure; OS, overall survival; sRMSdi/para/sc, root-mean-square of diaphragm/parasternal/sternocleidomastoidsurface electromyography; RMSdi, root-mean-square of diaphragmelectromyography; Pdi, transdiaphragmatic pressure; MIP, maximal inspiratorypressure; TC, total cholesterol; TG, triglycerides; PFS, progress free survival;MVIS, maximal voluntary isometric strength. |
