| Objective: 1.Through the traditional Chinese medicine theory research of non-alcoholic steatohepatitis（NASH）,the relationship between the method of " danyitongyang " and NASH and Insulin resistance（IR）was expounded.2.The efficacy of Yinchenwuling powder in the treatment of non-alcoholic fatty liver disease was evaluated by meta analysis which providing evidence-based medical evidence for the treatment of NAFLD with Yinchenwuling powder.3.To observe the clinical efficacy of modified Yinchenwuling Powder in the treatment of non-alcoholic steatohepatitis（NASH）with Dampness-heat Syndrome,and to explore its possible mechanism.4.NASH rat model was established by high-fat diet to explore the possible mechanism of action of modified Yin Chen Wu Ling Powder in the treatment of NASH.Methods: 1.Theoretical discussion:By sorting out the origin and development of the theory of tongyang,the origin,development and improvement of the theory of tongyang and the summary of the doctors of later generations are expounded,and the relationship between the method of tongyang and NAFLD is also expounded.2.Meta-analysis:Screening and quality evaluation of randomized controlled literatures published at home and abroad on the treatment of fatty liver by yinchen wuling powder addition or subtract were carried out.Meta-analysis was conducted on the total clinical response rate,AST,ALT,GGT,TC and TG of the intervention method using Revman5.3 software,and adverse reactions were recorded.3.Clinical test:According to the randomized control principle,patients were selected from outpatient and inpatient department of gastroenterology of Wuhan NO.1 hospital.Then the patients were randomly divided into TCM treatment group,TCM control group and western medicine control group.TCM treatment group was given Modified Yinchenwuling Powder,TCM control group was given Modified Yinchenhao Decoction and the western control medicine group was given polyene phosphatidylcholine.Patients’ clinical symptoms were scored every 4 weeks.The liver function,blood lipid level,Bultrasound and Fibrotouch degree of fatty liver degeneration,insulin resistance level were observed before and after treatment,and the total course of treatment was 12 weeks.4.NASH rats were divided into normal group,model group,TCM medicine group,TCM medicine+empty virus group,TCM medicine+ lentivirus group and pioglitazone group.Serum ALT,AST,TG,TC,and liver mi R-34 a,PPAR-α,FGF21 levels and liver HE staining were detected before and after treatment.Rusults : 1.Theoretical research: Yangqi barrier always exists during the occurrence and development of NASH,which is also a key link in the occurrence and development of NASH.Yangqi barrier is not usually adopted for Dampness-heat Syndrome of NASH.For Dampness-heat Syndrome of NASH,the method of danyitongyang is often adopted.2.The Meta analysis: A total of 798 subjects were included in 8 RCTS,including 400 in the treatment group and 398 in the control group.Literature quality evaluation: random grouping was mentioned in all 8 articles,and specific grouping methods were mentioned in only 6 articles,among which 5 were random number table method,one was random parallel grouping method,and two were not mentioned.Meta results showed that the clinical effective rate of Modified Yinchen Wuling Powder was better than that of control group[RR=1.24,95%CI（1.13,1.35）,P<0.01].The effect of Modified Yinchen Wuling Powder on ALT was better than that of control group[MD=-8.90,95%CI（-8.90,-7.37）,P<0.01].The effect of modified Yinchen Wuling Powder on AST was better than that of control group [MD=-15.61,95%CI（-16.53,-14.69）,P <0.01].The effect of modified Yinchen Wuling Powder on GGT was better than that of control group [MD=-17.50,95%CI（-18.46,-16.54）,P<0.01].The effect of Modified Yinchen Wuling Powder on TC was better than that of control group [MD=-1.08,95%CI（-1.19,-0.98）,P < 0.01].The effect of Yinchen Wuling Powder on TG was better than that of control group [MD=-1.39,95%CI（-1.59,-1.20）,P<0.01].3.Clinical trial: In terms of TCM clinical symptom score,the curative effect of TCM treatment group and TCM control group was superior to western medicine control group after 4weeks,8 weeks and 12 weeks（P<0.01）.There was no difference in curative effect between TCM treatment group and TCM control group（P >0.05）.There were no significant differences in body mass index（BMI）and waist-hip circumference（WHR）among the three groups before and after treatment（P > 0.05）.After 12 weeks of treatment,there were no significant differences in AST,ALT and GGT among the three groups（P > 0.05）.There were no significant differences in the efficacy of AST,ALT and GGT reduction among the three groups after 12 weeks of treatment.The western medicine control group reduced AST and ALT faster,and there was no significant difference in GGT reduction rate among the three groups.TG and TC of TCM treatment group after4,8 and 12 weeks were significantly lower than those before treatment（P<0.01）.TG was not significantly decreased at 4weeks after treatment（P>0.05）.TC was significantly decreased（P<0.01）.After 8 and 12 weeks of treatment,TC and TG decreased significantly（P<0.01）.After 12 weeks of treatment,the curative effect of reducing TG in the TCM treatment group was better than that in the TCM control group and the western medicine control group,and there was no significant difference in reducing TC among the three groups（P > 0.05）.There was no significant difference in IR between the TCM treatment group and the control group（P > 0.05）,but there was a difference between the TCM treatment group and the western medicine control group（P<0.05）.It can be considered that TCM treatment group and TCM control group have better efficacy in improving IR than western medicine control group.For FGF21,there was a significant increase after treatment in the Chinese medicine group compared with before treatment,while there was no significant difference between the other two groups（P>0.05）.For hepatic steatosis,liver steatosis in the three groups was significantly improved compared with before treatment,and there was no statistical significance among the three groups（P>0.05）.4.Animal experiment:The liver index of TCM group and pioglitazone group was significantly lower than that of normal group（P<0.01）.The liver index of TCM + lentivirus group was significantly higher than that of TCM group（P<0.01）.HE staining microscope: The normal group had clear hepatic lobule structure,normal size and shape of hepatocytes,and radially arranged hepatocytes.The hepatic lobule structure of rats in model group and Lentivirus group was severely damaged,liver cells were disordered,and a large number of fat vacuoles were observed in liver cells.The liver lobules in the Chinese medicine group,pioglitazone group and Chinese medicine + empty lentivirus group were intact,and fat vacuoles were found in a few liver cells,which were still radially arranged.The expression levels of ALT,AST,TC and TG in TCM group and TCM +empty virus group were lower than those in model group（P<0.01）.Compared with model group,serum ALT and AST levels in pioglitazone group were decreased（P<0.05）,while serum TC and TG levels were not significantly changed.Compared with model group,FBG,2h BG,Fins and HOMA-IR in TCM group and pioglitazone group were significantly decreased（P<0.01）.The expression of Mir-34 a in TCM group was significantly decreased,and the expression of PPAR-α and FGF21 m RNA was increased（P<0.01）.Conclusions:1.Yangqi barrier is the pathogenesis of dampness-heat accumulation syndrome of NAFLD.There is a rich theoretical basis for the treatment of NASH（dampness-heat accumulation syndrome）with Yinchenwuling Powder as the method of clearing heat and promoting diuresis and danyitongyang;2.Meta-analysis was used to systematically evaluate the literatures related to Yinchenwuling Powder in the treatment of NAFLD.It was found that Yinchenwuling Powder had good clinical efficacy in the treatment of NAFLD;3.Modified Yinchenwuling Powder can improve the clinical symptoms,body mass index,waist and hip liver function,blood lipid level,IR and glucose tolerance of NASH patients with damp-heat accumulation syndrome.It has no significant effect on improving body mass index and waist-hip circumference.The clinical symptoms,blood lipid,IR and glucose tolerance were improved better than those in the western control group.In improving blood lipid effect is better than TCM control group.4.Modified Yinchenwuling Powder can improve hepatic steatosis and IR,and its possible mechanism may be through decreasing the expression of mi R-34 a,and then up-regulating the expression of PPAR-αand FGF21. |
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