Clinical Study On Shugan Jianpi Pills Combined With Entecavir In The Treatment Of Chronic Hepatitis B Liver Fibrosis Of Liver Depression And Spleen Deficiency Type

Objective : To compare the clinical effects of entecavir alone and combined with Shugan Jianpi Pills in the treatment of liver fibrosis of chronic hepatitis B with liver depression and spleen deficiency.To observe the clinical efficacy of Shugan Jianpi Pills in improving TCM syndromes,liver function and inhibiting the further development of liver fibrosis.Methods : In this study,100 patients with chronic hepatitis B liver fibrosis diagnosed as liver depression and spleen deficiency were randomly divided into control group and observation group,50 cases in each group.The control group was given conventional western medicine treatment of entecavir0.5 mg qd po,and the observation group was treated with Shugan Jianpi Pill9 g on the basis of the control group,three times a day for 48 weeks.Observe and record the differences between the two groups in TCM symptom scores,liver instantaneous elasticity measurement,serological indicators before and after treatment,and comprehensively evaluate the safety and clinical efficacy of Shugan Jianpi Pills combined with entecavir in the treatment of chronic hepatitis B liver fibrosis with liver depression and spleen deficiency.Results :1.Basic information of enrollment: 100 patients were included in this study,including 4 cases in the observation group and 2 cases in the control group due to the epidemic and the inability of the patients to adhere to the medication for a long time.Finally,94 patients were studied.There were no significant differences between the two groups in terms of gender and age,which were comparable(P>0.05).2.TCM symptoms: After treatment,the total effective rate of TCM symptoms was 76% in the observation group and 46% in the control group,with a significant difference(P<0.05).After treatment,the observation group was better than the control group in reducing the TCM symptoms score(P<0.05).3.Determination of liver elastic LSM value: After treatment,the indexes of both groups were lower than before treatment(P<0.05),and the total effective rate of LSM in the control group was 20.8% lower than that in the observation group,which was 52.2%,indicating that the observation group was better than the control group in reducing LSM value.4.Liver function: After treatment,the indexes of both groups improved(P<0.05),and the observation group was better than the control group in reducing transaminase(ALT,AST)activity and increasing albumin level(P<0.05).5.Four indexes of liver fibrosis: after treatment,all four indexes of liver fibrosis decreased in both groups(P<0.05),and the improvement in the observation group was better than that in the control group(P<0.05).6.Antiviral aspect: the HBe Ag negative conversion rate in the observation group was higher than that in the control group after treatment,but there was no significant difference between the two groups after treatment.After treatment,HBV-DNA levels were improved in both groups,but the difference was not significant(P>0.05).Conclusion : Shugan Jianpi pill combined with entecavir in the treatment of chronic hepatitis B liver fibrosis with liver stagnation and spleen deficiency is better than entecavir alone.It has a good effect in improving the TCM syndrome score,four items of liver fibrosis,instantaneous elasticity of liver and reducing transaminase activity,and no obvious adverse reactions.