Clinical Study Of Batu Bushen Yigan Granules In Controlling Chronic Hepatitis B Disease Progress

Objective On the basis of the research on the clinical efficacy and safety of Batu Bushen Yigan Granules combined with ETV in controlling the disease progression of CHB patients,the clinical efficacy of Batu Bushen Yigan Granules combined with ETV in controlling the disease progression of CHB patients is further discussed and evaluated,and a CHB integrated traditional Chinese and western medicine treatment scheme with definite curative effect and applicable popularization is initially formed.Method We collected 100 HBe Ag(+/-)cases of CHB treated by ETV from December 2016 to December 2018 in the Department of Hepatology of Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine,and the syndrome differentiation of TCM was liver and kidney deficiency with damp heat.They were divided into treatment group and control group.The treatment group was given Batu Bushen Yigan Granules combined with ETV,while the control group was given ETV only.Both groups continued to observe and treat for 24 months.Blood routine,liver function,liver fibrosis serological index,AFP,Fibroscan,etc.were detected and calculated before admission(0 month)and in June,December,18 months and 24 months of treatment.Liver MRI,etc.were examined before admission(0 month)and 24 months of treatment,and the data were analyzed.Results 1.the ALT and AST levels in the treatment group showed a downward trend as a whole,and the decreasing range was higher than that in the control group(p< 0.05).2.HBV-DNA negative conversion rate in treatment group was 76.92%,HBe Ag serum negative conversion rate was 40.90%(9/22),HBe Ag/HBe Ab conversion rate was 30.43%(7/22),control group HBV-DNA negative conversion rate was 62.5%,HBe Ag serum negative conversion rate was 26.08%(6/23),HBe Ag/HBe Ab conversion rate was 17.39%(4/23).The decrease of HBs Ag was more obvious in the treatment group(p< 0.05),but there was no significant difference in the decrease of HBs Ag between the two groups(p> 0.05).3.the levels of HA,LN,PC? and ?C in the two groups all showed a downward trend,and the decreasing range in the treatment group was higher than that in the control group(p< 0.05).4.the level of Fibroscan in the treatment group showed a decreasing trend,and the decreasing range was significantly higher than that in the control group(p< 0.001).The b-ultrasonic integral value of the treatment group decreased significantly overall,while that of the control group increased overall,with significant difference between the two groups(p< 0.001).In this experiment,61 patients completed MRI examination and 10 patients(3 in the treatment group and 7 in the control group)with cirrhosis were observed.The incidence of cirrhosis in the control group was significantly higher than that in the treatment group.5.APRI index,FIB-4 index and GPR index in the treatment group all showed a downward trend,and the decreasing range was higher than that in the control group(p< 0.05).6.AFP and AFU levels in the treatment group showed a downward trend,and the decrease was greater(P< 0.05).7.TCM symptom scores in the treatment group decreased significantly compared with the control group(p< 0.001).The total effective rate of the treatment group is 78.72%,and that of the control group is 53.48%.The clinical effect of the treatment group is better than that of the control group.8.There is a certain continuity between this test and the previous test.No ETV drug resistance was found in some cases during the previous treatment and the observation period of this test.In addition,no blood routine,renal function and other damages were found in 90 patients during the 24-month treatment,and no other serious adverse events occurred.Conclusion Batu Bushen Yigan Granules combined with ETV can improve liver function,increase E antigen negative conversion rate and conversion rate,reduce HBs Ag level and HBV DNA titer in the treatment of CHB with liver and kidney deficiency and damp-heat syndrome,and reduce serum liver fibrosis index to a certain extent.It can obviously improve symptoms of hypochondriac pain,anorexia,asthenia,tinnitus,soreness of waist and knees,bitter taste and the like of patients,improve liver fibrosis degree,reverse and delay liver fibrosis process,and can obviously control disease progress of CHB.