Clinical Study On Rougan Huaxian Granule Combined With Entecavir In The Treatment Of Chronic Hepatitis B Liver Fibrosis

Objective:To observe the effect of Rougan Huaxian granule combined with entecavir on liver function,HBV DNA,liver fibrosis index,liver hardness value,TCM syndrome score and peripheral blood cell immune function in patients with chronic hepatitis B liver fibrosis.Methods:60 patients who met the inclusion criteria were randomly divided into control group and treatment group,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.Both groups were treated for 24 weeks.The changes of liver function(ALT,AST),liver stiffness(LSM),liver fibrosis indexes(HA,PCIII,IV-C,LN),HBV DNA,TCM syndrome score and peripheral blood T lymphocyte subsets(CD3~+,CD4~+,CD8~+)were observed and recorded before and after treatment.Results:(1)Comparison of liver function between the two groups:after treatment,AST and ALT in the control group and the treatment group were decreased compared with those before treatment(P<0.05),and the decrease degree of AST and ALT in the treatment group was significantly higher than that in the control group(P<0.05).(2)Comparison of HBV DNA negative conversion rate between the two groups:after treatment,the HBV DNA negative conversion rates of the control group and the treatment group were higher than those before treatment(P<0.05),and the treatment group was better than the control group(P<0.05).(3)Comparison of T lymphocyte subsets between the two groups:after treatment,there was no significant difference in CD3~+,CD4~+,CD8~+between the control group and before treatment(P>0.05);In the treatment group,CD3~+,CD4~+increased,CD8~+decreased(P<0.05),and the treatment group was better than the control group(P<0.05).(4)Comparison of liver hardness value between the two groups:after treatment,the liver hardness value of the control group and the treatment group decreased compared with that before treatment(P<0.05),and the liver hardness value of the treatment group was lower than that of the control group(P<0.05).(5)Comparison of serum liver fibrosis indexes between the two groups:after treatment,the levels of HA,PCⅢ,IV-C and LN in the control group and the treatment group were significantly lower than those before treatment(P<0.05),and the levels of HA,PCⅢ,IV-C and LN in the treatment group were significantly lower than those in the control group(P<0.05).(6)Comparison of TCM syndrome scores of the two groups:after treatment,TCM syndrome scores of the control group and the treatment group decreased compared with those before treatment(P<0.05),and TCM syndrome scores of the treatment group were lower than those of the control group(P<0.05).(7)After treatment,the total effective rate of the control group was 60%,the total effective rate of the treatment group was 86.67%,the total effective rate of the treatment group was higher than that of the control group(P<0.05).Conclusion:(1)Rougan Huaxian granule combined with entecavir can improve the liver function of patients with chronic hepatitis B liver fibrosis,increase the negative rate of HBV DNA,reduce the liver hardness value and serum liver fibrosis index.(2)Rougan Huaxian granule combined with entecavir can improve TCM syndrome score,improve clinical comprehensive efficacy,and has good safety.(3)Rougan Huaxian granule combined with entecavir may regulate cellular immune function by up regulating CD3~+,CD4~+,down regulating CD8~+,so as to reduce hepatocyte damage and delay the occurrence and development of liver fibrosis.