| [Research purposes]: The Clinical study is branch of Wuhan Science and Technology subject- "The role of inflammatory cytokines mediated by NF-k B signal path in non-alcoholic steatohepatitis pathogenesis and mechanism of Yin Qin Qing Gan Decoction increase or decrease(Fund Code WZ15C05)". Yin Qin Qing Gan Decoction created by Professor Zhang Yaxi for treating liver and gallbladder diseases,have been confirmed to have the obvious effect on relieving symptoms and improving liver function at human and rats who suffered from alcoholic fatty liver in the early animal experiments and clinical observation.Since alcoholic steatohepatitis is similar with non-alcoholic steatohepatitis in the clinical and pathological, Yin Qin Qing Gan Decoction is also used to treat non-alcoholic steatohepatitis, and achieved good effect too. The clinical study mainly observe curative effect of Qin Qing Gan Decoction treating non-alcoholic steatohepatitis,and make comparison with reductive glutathione.At the same time,we detect expression of inflammatory cytokines(TNF-a,IL-6) after treatment. Finally,We analyze the research result and provide a theoretical basis for clinical application of Yin Qin Qing Gan Decoction and it,s possible mechanism.[Research methods]: 1.In the paper, 80 patients are in line with the diagnostic criteria of the Chinese Medical Association Hepatology and alcoholic fatty liver disease study group developed non-alcoholic steatohepatitis [1]; Chinese medicine diagnostic standard reference "Chinese disease diagnosis and efficacy standards." about Liver yu uand spleen depression[2]. The selected patients were randomly divided into two groups, namely treatment group(Yin Qin Qing Gan Decoction group)40 cases and comparison group(reductive glutathione) 40 cases.Two groups have comparation in gender, age, severity, body mass index. 2.Chinese medicine treatment group were treated with Yin Qin Qing Gan Decoction increase or decrease and comparison group were treated with reductive glutathione.We detected two groups, liver function、lipid、TNF-a、IL-6 and liver ultrasound after treatment of two weeks, one month and two months. At same times,we used Chinese medicines, diagnosis to assesse patient symptom scores at each time point.[Research result]: 1.After two months treatment, both groups obtained varying degrees of efficacy,traditional Chinese medicine group had better efficacy than the reductive glutathione group. The total effective rate of traditional Chinese medicine group group was 92.5%, while,the total effective rate of reductive glutathione group was 67.5%.The differences between two groups have statistically significant(P=0.000,<0.01);2.After two weeks of treatment,traditional Chinese medicine group has been significantly improved in liver function ALT, GGT, ALP, DBIL, and compared with the reductive glutathione group, the differences were statistically significant(P=0.000, <0.01); One month and two months after treatment, improvement in traditional Chinese medicine group in ALT, AST, GGT, ALP, DBIL, TC, TG has always better than the reductive glutathione group,and the differences between two groups were statistically significant(P=0.000, <0.01); But in HDL, LDL aspects,two groups all had no significant effect; At liver ultrasound,the two groups work to improve ultrasound imaging results, and is more obvious on mild fatty liver than severe fatty liver; 3.After two weeks of treatment, treatment group symptom scores had been significantly improved, especially in the individual symptom hypochondriac pain 、 bloating 、 lassitude 、 tongue 、 pulse.Compared with the reductive glutathione group, the reductive glutathione group had obvious advantages; With continued treatment time, in improving the individual symptoms had always superior to reductive glutathione group. the differences between two groups were statistically significant(P=0.000,<0.01); 4.With the treatment lasted, the expression levels of serum TNF-a, IL-6 gradually decreased in two groups of patients(P<0.05 or P=0.000,<0.01).The reductive glutathione group reduced rate lower than reductive glutathione group. The difference between the two groups before and after treatment group were statistically significant(P=0.000,<0.01).[Analysis conclusion]: 1. Yin Qin Qing Gan Decoction increase or decrease can significantly improve the overall clinical efficacy of liver and spleen deficiency in patients with non-alcoholic hepatitis, and has more obvious comparative advantage than reductive glutathione therapy; 2.Yin Qin Qing Gan Decoction increase or decrease can effectively improve the non-alcoholic hepatitis patients, liver function and blood lipids, especially in improving serum ALT, AST, ALP, GGT, DBIL, TC, TG aspect, but no significant effect on LDL, HDL. 3.Yin Qin Qing Gan Decoction increase or decrease can significantly improve non-alcoholic hepatitis patients, TCM clinical symptoms and signs 4.Yin Qin Qing Gan Decoction increase or decrease can inhibit the non-alcoholic hepatitis expression of inflammatory cytokines(TNF-a, IL-6), and may be related to the immune system by inhibiting the inflammatory disorder mediated signal pathway. 5.Yin Qin Qing Gan Decoction increase or decrease can protect the liver through a variety of ways, and the security is good, has no adverse reactions. Compared with the current western medicine, Yin Qin Qing Gan Decoction has obvious advantages, worthy of further research and development and clinical application. |