Clinical Study Of Rougan Huaxian Granule Combined With Entecavir In The Treatment Of Hepatitis B Cirrhosis Compensated Period (Syndrome Of Yin Deficiency Of Liver And Kidney)

Objective: This study compared the clinical efficacy and the effects of oxidative stress of Rougan Huaxian Granules combined with Entecavir and Entecavir alone in the treatment of patients with hepatitis B cirrhosis compensation period(syndrome of yin deficiency of liver and kidney),to explore effective,safe and feasible anti-liver fibrosis and delay the progress of liver cirrhosis with integrated Chinese and Western medicine treatment.Methods: According to the inclusion criteria,60 patients who were admitted to our hospital from March 2017 to March 2018 were randomly divided into the control group and the treatment group,with 30 cases in each group.The control group was treated with Entecavir alone,and the treatment group was treated with Rougan Huaxian Granules combined with Entecavir for a 48-week clinical study.Before treatment,at 24 weeks,and 48 weeks of treatment,observe and record the liver function(AST,ALT,TBIL)and liver fibrosis(HA,LN,PC-III,IV-C),LSM,oxidative stress indicators(SOD,MDA,GSH-PX),TCM symptom scores.AT 24 weeks,48 weeks of treatment,the conversion rate of HBV DNA,clinical efficacy,and adverse reactions were recorded.After the end of clinical observation,the collected data were statistically analyzed to compare the therapeutic effects of the two groups of patients.Results:(1)Clinical efficacy: At 24 and 48 weeks of treatment,the clinical efficacy of the treatment group and the control group were compared,the difference was statistically significant(P<0.05).(2)Liver function indicators: At 24 weeks of treatment,alanine aminotransferase(ALT),aspartate aminotransferase(AST),and total bilirubin(TBIL)were compared between the two groups,and the differences were statistically significant(P<0.05).At 48 weeks of treatment,the ALT of the two groups were compared,the difference was statistically significant(P<0.05).At 48 weeks of treatment,AST and TBIL in the treatment group were compared with AST and TBIL in the control group,and the difference was not statistically significant(P>0.05).(3)Liver fiber index: hyaluronic acid(HA),laminin(LN),type III procollagen(PC-III),type IV collagen(IV-C)in the two groups at 24 weeks of treatment,The differences between the two groups were statistically significant(P<0.05).At 48 weeks of treatment,HA,LN,and PC-III were compared between the two groups,and the differences were statistically significant(P<0.05).The IV-C of the treatment group was compared with the IV-C of the control group,and the difference was not statistically significant(P>0.05).(4)Liver hardness value(LSM): At 24 weeks and 48 weeks of treatment,the LSM of the treatment group and the control group were compared,the difference was statistically significant(P<0.05).(5)Oxidative stress indicators: At 24 and 48 weeks of treatment,superoxide dismutase(SOD),malondialdehyde(MDA),and glutathione peroxidase(GSH-PX)were compared between the two groups,and the differences were statistically significant(P<0.05).(6)Virological response of HBV DNA: There was no significant difference(P>0.05)in the rate of HBV DNA conversion between the two groups at 24 and 48 weeks of treatment.(7)TCM syndrome scores: The TCM syndrome scores of the two groups were compared at 24 and 48 weeks of treatment,and the difference was statistically significant(P<0.05).(8)Safety observation: During the clinical study period,the safety indicators of the two groups of patients showed no obvious abnormalities,no adverse reactions occurred,and toxic side effects appeared,which had high safety.Conclusion:(1)Compared with patients treated with Rougan Huaxian Granule combined with Entecavir and Entecavir alone in the treatment of hepatitis B cirrhosis compensated(syndrome of yin deficiency of liver and kidney),Combination therapy is more effective in increasing SOD and GSH-PX in the serum of patients and reducing the production of MDA,a product of lipid peroxidation.(2)Rougan Huaxian Granule combined with Entecavir treatment can improve liver function,liver fibrosis,LSM and TCM syndrome scores more effectively,and improve clinical efficacy.(3)The combination of Rougan Huaxian Granule and Entecavir may improve the liver function,liver fibrosis,LSM and TCM symptoms through anti-oxidative stress,anti-liver fibrosis and delay the progression of cirrhosis.