| Objective: To observe the clinical curative effect of Lizhong decoction combined with entecavir treatment in patients with Spleen Yang deficiency syndrome of Taiyin disease of decompensated hepatitis B cirrhosis,safety and its effect on intestinal microflora,and further observation of Lizhong Decoction on the general situation of rats after interventionin rats with liver cirrhosis,liver pathological changes and changes of intestinal microflora,revealing the Spleen Yang is the basic pathogenesis of traditional Chinese medicine essence of hepatitis B cirrhosis,and to explore the possible mechanism of classical prescription therapeutic mechanism of Lizhong Decoction in treatment of liver cirrhosis and hepatic fibrosis.Methods:(1)Clinical research:95 Patients who met the inclusion criteriao syndrome decompensated hepatitis B cirrhosis belonging to disease spleen Yang deficiency were divided into the treatment group with32 cases,control group with 32 cases and blank group with 31 casesaccording to random number table method.The treatment group combined entecavir to Lizhong decoction,while Control group used Dichotomous triple viable capsulesand entecavir,Blank used entecavir treatment group.course of treatment were 3month.After the treatment,three groups of patients compared before and after the treatment of clinical symptoms,liver function,HBe Ag serological overcast rate,liver hardness value(KPA),serum endotoxin and serum inflammatory factor,changes of intestinal flora,and adverse reactions.(2)Animal studies:Using carbon tetrachloride combined with ethanol,the composite factors of high fat diet model of healthy SPF male SD rats liver cirrhosis rat model.Rats were randomly divided into normal blank group,model group rats,rats soup in low dose group,the soup in the highdosage groups.Blank group and model group were given equal volume of distilled water(2ml/kg/d)orally,1 times a day.Lizhong decoction high dose group was drenched 1.5×8.75g/kg/d Chinese medicine,and Lizhong decoction low dose group was drenched0.5×8.75g/kg/d,1 times a day.Observation was 4 weeks.After the treatment,Four groups after intervention liver pathological tissues of liver fibrosis in rats,intestinal flora,inflammatory factor change were observed.Results:(1)clinical research:due to lost to followup,complication sand not according to requirements of treatment,5 cases were wed out during observation process.The real effective cases were 90 cases and each group had 30 cases.After treating in the observation,Treatment group and control group were improved on clinical symptoms,liver function,liver hardness value,serum endotoxin and serum inflammatory factor and intestinal flora comparing with untreated.The difference was statistically significant(P<0.05).Two groups of HBe Ag serological overcast rate has no obvious change before,whose difference was statistically significant(P<0.05).Blank group the indexes after treatment has no obvious change compared to untreatment,whose difference was statistically significant(P<0.05).After treatment,the treatment group and control group showed a statistically significant(P<0.05)in clinical symptoms,liver function,liver hardness value,serum endotoxin and serum inflammatory cytokines and intestinal flora between group compared with the blank group.Three groups of HBe Ag serological overcast rate has no statistical significance(P<0.05).Treatment group the difference was statistically significant(P<0.05)in improving the patients clinical symptoms and serum endotoxin,IL17,intestinal flora(including Bifidobacterium,lactobacillus,enterococcus and ecoli)compared with control group.In the process of treating,the three groups of patients are nontoxic side effects and adverse events.(2)Animal studies:Four groups of rats with HE staining pathology results show that the extent of fibrosis in model group is one of the mostserious.Lizhong decoction in low dose group and high dose group with increasing doses,fibrosis degree could gradually reduce.Compared with the blank group rats,in the aspect of serum inflammatory factors,model group rats serum TGFbeta,IL17,IL23 levels were elevated(P<0.05).Compared with the low dose group of Lizhong decoction,high dose group of TGFbeta,IL17 content reduced(P<0.05).Compared with the blank group rats in the aspect of intestinal flora,serum enterobacter and enterococcus,Wei Rong aureus levels of model group rats were elevatedwhile Bifidobacterium,lactobacillus,bacteroides content reduced(P<0.05).Compared with model group rats,serum enterobacter and enterococcus,Wei Rong aureus levels of Lizhong decoction with low and high dose group of group rats were reduced while Bifidobacterium,lactobacillus,bacteroides content reduced(P<0.05).Compared with the low dose groupof Lizhong decoction,high dose group of intestinal bacteria were decreased,while Bifidobacterium content increased(P<0.05).Conclusions: Lizhong decoction combined with entecavir treatment of decompensated hepatitis B cirrhosis patients,curative effect,the patients can regulate the intestinal microflora,serum endotoxin and inflammatory factor levels;liver cirrhosis rats have intestinal microecology performance,Lizhong decoction has the same regulation of intestinal of rats with cirrhosis of liver micro environment,reduce the levels of inflammatory factors and the role of highdose effect is more obvious;the clinical and animal experimental study showed that,the Lizhong decoction may be through the mechanism of regulation of liver cirrhosis intestinal microflora exerts its anti liver fibrosis,spleen deficiency is to verify the basic pathogenesis of traditional Chinese medicine essence of liver cirrhosis. |