Clinical Study Of Tablets Of Biejia Ruangan Combined With Entecavir Resist Hepatitis B Hepatic Fibrosis

Objective:The purpose of this study was to observe the efficacy and safety of Tablets of biejia ruangan combined with entecavir for anti hepatitis B fibrosis,The research enriches and perfects Tablets of biejia ruangan anti hepatitis B liver fibrosis,Accumulation of knowledge and experience of traditional Chinese medicine on liver fibrosis of hepatitis B.provide evidence of the efficacy and safety of Tablets of biejia ruangan anti hepatitis B fibrosis.to provide reliable clinical guidance and reference for the treatment of chronic hepatitis B liver fibrosis.Method:A randomized,double-blind,controlled trial design was used,Patients accord with inclusion and exclusion criteria,Subjects were randomly divided into experimental group and control group according to Central stochastic system,Ratio of 1:1(Finally,72 patients completed the trial).Accept the following intervention:Test group(n=34):Entecavir,0.5mg,qd,Tablets of biejia ruangan,4 tablets,tid;Control group(n=38):Entecavir,0.5mg,qd,Tablets of biejia ruangan simulation agent,4 tablets,tid.Observation time point:0-72 week,Observation index:liver pathology,hepatic elastic hardness test,liver function,blood coagulation,abdominal ultrasound,AFP,HBV-DNA,blood routine,renal function,myocardial enzyme,urine routine,stool routine + occult blood,ecg.Results:(1)The curative effect of Tablets of biejia ruangan combined with entecavir resist hepatitis B Hepatic Fibrosis,A total of 72 patients with chronic hepatitis B were completed,including the experimental group(n=34)and the control group(n=38);(2)After following up for 72 weeks,there were 44 patients did a 2 times liver puncture at 0 and seventy-second weeks,test group 21 cases,control group of 23 cases;In the experimental group,12 cases were markedly effective,effective in 5 cases,ineffective in 4 cases,the total effective rate was 80.95%;In the control group,8 cases were markedly effective,effective in 2 cases,ineffective in 13 cases,the total effective rate was 43.48%;After statistical analysis,the treatment group was better than the control group(P<0.05).(3)Imaging aspects,Comparison of the abdominal ultrasound and FibroScan before and after treatment,after statistical analysis,there was no significant difference between the experimental group and the control group(P>0.05).(4)On the improvement of APRI score,The two groups after treatment were significantly lower than before treatment(P<0.01),However,the test group was significantly lower than the control group(P<0.05),The impact of the FIB-4 index,Compared with before treatment,the experimental group had decreased,the difference was statistically significant(P<0.05),while the control group had no significant improvement(P>0.05).(5)Two groups of patients with transaminase(ALT,AST)in the treatment for after 24 weeks,48 weeks,72 weeks,compared with before treatment were significantly decreased(P<0.01).Two groups of white ball ratio(A/G)in the treatment for 48 weeks,there was a significant increase in(P<0.01),the value of the same period between the two groups was not statistically significant(P>0.05).(6)There was no significant difference between the two groups in the HBV-DNA negative rate(P>0.05).(7)During the experiment,the main safety indexes of the experimental group and the control group were not significantly abnormal,There were 2 cases diarrhea and abdominal pain in 1 patients,no adverse reactions were found in other patients.Conclusions:(1)Tablets of biejia ruangan combined with entecavir can effectively reverse hepatic fibrosis,improve the quality of life of patients.(2)Tablets of biejia ruangan combined with entecavir therapy is safe and effective,worthy of promotion.