Clinical Study Of Bushen Jianpi Decoction Combined With Entecavir In The Treatment Of HBeAg-negative Chronic Hepatitis B

Objective: To evaluate the clinical efficacy and safety of Bushen Jianpi Decoction combined with Entecavir in the treatment of HBeAg-negative chronic hepatitis B patients.Methods: Include 60 eligible HBeAg-negative chronic hepatitis B patients,and carry out a completely randomized controlled clinical study of the optimized plan of integrated traditional Chinese and Western medicine.According to a 1:1 ratio,they were randomly divided into treatment group and control group,with 30 cases in each group.The observation group was treated with Bushen Jianpi Decoction combined with entecavir for 48 weeks,and the control group was treated with single agent entecavir for 48 weeks.Each observation point(0 weeks,24 weeks,48 weeks)was tested and recorded in the two groups of patients with HBs Ag(quantitative)and liver function(ALT,AST),HBV-DNA,TCM syndrome score changes and adverse events.Results: 1.Comparison of HBs Ag negative conversion rate,HBV-DNA negative conversion rate,and ALT return to normal rate between the two groups of patients: After 24 weeks of treatment,the HBs Ag negative conversion rate of the observation group and the control group were both 0.After 48 weeks of treatment,the two groups of HBs Ag negative The rate of rotation is still 0.After 24 weeks and 48 weeks of treatment,the HBV-DNA negative conversion rate of the observation group and the control group was significantly higher than that before treatment,and the negative conversion rate of the observation group was higher than that of the control group(P>0.05).After 24 weeks and 48 weeks of treatment,the ALT return to normal rate in the observation group were 80.00% and 96.67%,respectively,and the ALT return to normal rate in the control group were 76.67% and86.67%,respectively.The ALT return to normal rate of the two groups of patients increased with the treatment time.Prolonged and increased.Compare the ALT return rate of the two groups after 24 weeks of treatment.The observation group is higher than the control group(P>0.05).After 48 weeks of treatment,the ALT return rate of the observation group is still higher than that of the control group and P<0.05,the difference is There is statistical significance.2.Comparison of HBs Ag titer between the two groups of patients: After 24 weeks of treatment,there was no significant difference in HBs Ag titer between the two groups,P>0.05;after 48 weeks of treatment,the observation group decreased significantly compared with the control group,P<0.05,the difference was statistically significant.3.Comparison of liver function indexes(ALT,AST)between the two groups of patients: at the 24 th and 48 th weeks after treatment,the ALT and AST of the observation group and the control group decreased compared with before the treatment(P<0.05).At the 24 th week,the observation group AST was lower than the control group(P>0.05),and the observation group’s ALT was lower than the control group(P<0.05).At the 48 th week of treatment,the observation group’s ALT and AST were still lower than the control group and P<0.05.4.Comparison of TCM syndrome scores of the two groups of patients: After24 and 48 weeks of treatment,the TCM syndrome scores of the observation group and the control group decreased compared with before treatment,and the TCM syndrome scores of the observation group improved better than the control group,P<0.05.5.Comparison of the efficacy of TCM symptoms between the two groups of patients: After 48 weeks of treatment,the total effective rate of the observation group was 96.67%,the total effective rate of the control group was 70%,and the total effective rate of the observation group was higher than that of the control group.The difference was statistically significant(P< 0.05).6.Comparison of the safety of treatment: During the treatment period,2patients in the experimental group developed diarrhea.Without other drug treatment,the diarrhea symptoms could be relieved and healed within 3 days,regardless of the adverse reactions caused by the drugs,and no adverse events were found.Conclusions: Bushen Jianpi Decoction combined with Entecavir has definite curative effect in the treatment of HBeAg-negative chronic hepatitis B.It is significantly better than entecavir in terms of improving clinical symptoms,reducing HBs Ag quantitative,and improving liver function,indicating that the combination of Bushen Jianpi Decoction is better than entecavir.Entecavir has certain clinical application prospects in the treatment of HBeAg-negative chronic hepatitis B.