刚刚收到通知,关于氢水治疗慢性乙肝的临床研究论文被Clinical and Translational Science 接受,这是国际上首次关于氢气治疗病毒性肝炎的临床研究论文,也是中国学者在国际上发表的第二篇关于氢水治疗疾病的临床研究,是我们小组和江苏淮安第四人民医院夏春祥医师合作完成的。
该研究采用临床对照研究,让60名慢性乙肝患者分别饮含氢水(30人)或对照无氢水(30人),每天1200-1800 ml/d,连续6周,通过检测患者氧化应激、肝脏功能和病毒滴度等指标,结果发现,该治疗方法对患者肝脏功能和病毒滴度没有作用,但可以提高患者抗氧化能力,减少氧化损伤,提示氢气水对慢性乙肝具有积极意义。
慢性乙型肝炎是由乙型肝炎病毒(HBV)引起的一种世界性疾病。发展中国家发病率高,据统计,全世界无症状乙肝病毒携带者(HBsAg携带者)超过2.8亿,我国约占1.3亿。多数无症状,其中1/3出现肝损害的临床表现。目前我国有乙肝患者3000万。乙肝的特点为起病较缓,以亚临床型及慢性型较常见,本病主要通过血液、母婴和性接触进行传播。目前临床上对这一疾病的治疗并没有理想的手段,乙肝疫苗的应用是预防和控制乙型肝炎的根本措施。作为乙肝大国,寻找可能的治疗方法一直是临床医学研究者渴望的目标。
炎症病毒性肝炎重要的病理生理学过程,氢气是最近发现的一种新型抗氧化抗炎症分子,对多种氧化应激和炎症相关疾病具有理想的治疗效果,但过去没有任何关于对病毒性疾病治疗的基础和临床研究。本研究是对这一疾病治疗的首次尝试,虽然研究中没有发现对肝脏功能和病毒数量产生显著的治疗作用,但从氧化应激角度仍带来令人激动的消息。
这一研究给我们许多启示,首先,临床研究虽然注重有效性,但仍对创新性比较重视,我们经过几次投稿失败中体会到这个问题,开始我们总希望强调无效的客观原因,不注重本课题首次开展氢治疗病毒性疾病的创新性,后来逐渐意识到这个问题,终于获得了同行的认可。在专家意见中明确提出,尽管该研究没有确认氢对病毒性肝炎的治疗效果,但是这一领域的首次尝试,仍具有发表的价值,并对我们的研究给以很不错的评价。其次,关于临床研究和基础研究的区别,我们发现虽然氢对一些疾病动物模型中发现的效果非常好,但临床研究往往并不理想,一般需要更长的治疗时间,例如最少的观察时间是8周,本研究是7周,而最近日本学者对巴金森病的研究中发现,连续治疗6月没有效果,但12个月则发现有明显的效果。因此本研究虽然没有观察到治疗效果,不等于长期治疗没有效果,仍值得继续深入研究。再次,关于指标的选择上,本研究虽然采用了多种分子生物学技术,选择的研究内容也是乙肝重要的肝脏功能和病毒滴度等指标,但忽视了一个更为重要的炎症反应指标。由于临床研究不象动物实验,出现问题可以随时补充修改。我们可以尽快补充一批动物,但人体实验一旦完成,很难进行补充实验。这给将来的临床研究积累了重要经验,就是需要在设计上反复推敲确认。
Effect of hydrogen rich water on oxidative stress, liver function and viral load in patients with chronic hepatitis B
Xia CX1, Liu WW3, Zeng DX1, Zhu LY2, Sun XL2, Sun XJ3
Abstract
Objective: This study aimed to investigate the effects of hydrogen-rich water on oxidative stress, liver function and HBV DNA in patients with chronic hepatitis B (CHB).
Methods: A total of 60 patients with CHB were recruited and randomly assigned into routine treatment group and hydrogen treatment group. In the routine treatment group, patients received routine treatment alone; in the hydrogen treatment group, patients were orally given hydrogen rich water twice daily (1200-1800 ml/d) for consecutive 6 weeks. Serum was collected before and after treatment for the detection of the oxidative stress related parameters (SOD, GST, XOD, MDA, LOP). At the same time, the liver function (ALT, TbiL, ChE) and HBV DNA level were detected before and after treatment. In addition, 30 healthy subjects served as controls.
Results: When compared with controls, oxidative stress was obvious in CHB patients, which was characterized by decrease in SOD and GST activities and increase in XOD activity, MDA and LOP, and the liver function was also significantly impaired. After treatment, the oxidative stress remained unchanged in the routine treatment group, but markedly improved in the hydrogen treatment group. The liver function was improved significantly and the HBV DNA reduced markedly after corresponding treatments. In addition, as compared to the routine treatment group, the oxidative stress was dramatically reduced after hydrogen treatment, but the liver function and HBV DNA level were comparable between two groups although there were improved tendencies.
Conclusion: Treatment with hydrogen rich water can significantly attenuate the oxidative stress in CHB patients, but further study with long-term treatment is required to confirm the effect of hydrogen-rich water on liver function and HBV DNA level.
Key words: Hydrogen rich water; oxidative stress; liver function; chronic hepatitis B
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