Clinical Observation Of Baihua Xianglian Detoxification Granule Combined With Entecavir In Treating HBeAg Positive Chronic Hepatitis B

Objective:To evaluate the clinical efficacy and safety of Baihua Xianglian Detoxification granule combined with entecavir in treating HBeAg positive Chronic Hepatitis B.Methods:A total of 60 patients with HBeAg positive chronic hepatitis B who matched with the inclusion criteria were randomly divided into the experimental group and the control group with 30 patients in each group.The control group was treated with ETV,and the experimental group was treated with Baihua Xianglian Detoxification granule on the basis of the control group.The course of treatment was 48 weeks.The serum HBV DNA,Hepatitis B Virus Markers,T cell subgroup,TCM symptom score,liver function and adverse events were examined and recorded at 0,12,24 and 48weeks.Results:1.Comparison of comprehensive efficacy:The total effective rate of the experimental group was 86.67%and the control group was63.33%.The clinical effect of the experimental group was better than the control group(P<0.05).2.Comparison of HBV DNA conversion rate,HBeAg serological conversion rate,HBsAg serological conversion rate and ALT recurrence rate:The HBV DNA conversion rate,HBeAg serological conversion rate and HBsAg conversion rate were 0 after 12 weeks of treatment in the experimental group and the control group.With the extension of the treatment,both the two group of the HBV DNA negative conversion rate and HBeAg serological conversion rate were higher than before treatment after 24 weeks and 48 weeks,and the experimental group was higher than the control group(P>0.05).The HBsAg conversion rate of patients in the two groups increased after 24 weeks and 48 weeks of treatment,but there was no significant difference between the two groups(P>0.05).After 12 weeks and 24 weeks of treatment,ALT recurrence rate in the experimental group was higher than the control group(P>0.05).After 48 weeks of treatment,the rate of ALT recurrence in the experimental group was higher than the control group(P<0.05).3.Comparison of serum HBV DNA:Compared with the same observation time between the two groups,serum HBV DNA in the experimental group decreased faster than the control group(P<0.05).4.Comparison of HBeAg titers:After treatment(12,24,48 weeks),the titers of HBeAg in the experimental group and the control group were lower than before treatment(P<0.05).The HBeAg titer in the experimental group was lower than the control group after 12 weeks of treatment(P>0.05).After24 and 48 weeks of treatment,the HBeAg titer in the experimental group was lower than the control group(P<0.05).5.Comparison of major liver functions(ALT and AST):After treatment(12,24,48 weeks),the ALT and AST of each detection point in the experimental group and the control group all decreased compared with that before treatment(P<0.05),while the ALT and AST in the experimental group were lower than those in the control group(P<0.05).6.Comparison of TCM symptom score:After treatment(12,24,48 weeks),the TCM syndrome score in both the experimental group and the control group were lower than those before treatment(P<0.05),while the TCM syndrome score in the experimental group were lower than the control group(P<0.05).7.Comparison of T cell subsets:T cell subsets of the control group were compared before treatment and after treatment(48 weeks),and the differences were not statistically significant(P>0.05).After treatment(48weeks),the CD3~+,CD4~+,CD4~+/CD8~+in the experimental group were all higher than before treatment(P<0.05).And the experimental group was higher than the control group(P<0.05).8.Comparison of safety:Four patients in the experimental group had diarrhea symptoms.They could relieve by themselves without adding drugs in two days.There were no special adverse events in the remaining patients.Conclusions:There is curative clinical efficacy effect and less side effects in treating HBeAg positive CHB by Baihua Xianglian Detoxification granules combined with entecavir,which can significantly improve the clinical symptoms,accelerate HBV DNA negative conversion and HBeAg seroconversion,regulate immunity,protect liver and so on.The mechanism may be related to the increase of CD3~+,CD4~+,CD4~+/CD8~+and the improvement of immunity by Baihua Xianglian Detoxification granule.