Clinical Study On Additional FuZheng SanXie Recipe Combined With Telbivudine In Treating Liver-qi With Deficient Spleen Of HBeAg-positive Chronic Hepatitis B

Background:The anti-viral treatment can improve liver function, reduce liver disease, reduce or prevent cirrhosis and hepatocellular carcinoma. The anti-viral treatment is the mainstream treatment and the future development of chronic hepatitis B. The current anti-virus programs used in the clinic 1 year HBeAg seroconversion rate differential, LAM about 16%, ADV about 12%, ETV about 21%, LdT about 22.5%. Although LdT can get a higher rate of the treatment of HBeAg seroconversion, but it has led to increased risk of CK, limiting clinical application.So it is necessary to explore improved biochemical response, virologic response, histologic response and also that the high rate of HBeAg seroconversion new Program.Objective:To study the efficacy and safety of additional FuZheng SanXie Recipe combined with Telbivudine in treating Liver-qi with Deficient Spleen of HBeAg-positive Chronic Hepatitis B.Design, setting, participants and interventions:A random, positive parallel control design principles, a total of 90 cases of patients enrolled,45 patients were randomly divided into treatment group and control group 45 cases.All the cases come from Affiliated Hospital of Chengdu University of Traditional Chinese Medicine out-patient infected partment.Control group who received Telbivudine monotherapy and the treated group treated by additional FuZheng SanXie Recipe+Telbivudine for 52 weeks.Main outcome measures:The TCM syndrome score, biochemical response, virological response, serological response, the liver histologic response and adverse reactions in two groups were observed and comparedResults:1. Into the group of circumstances:A total of 81 patients (treatment group 41 cases,40 cases in control group) patients completed 52 weeks of the study. There was no significant different in gender,age,baseline HBV-DNA and ALT level histological changes between the groups before treatment,P> 0.05.2. Chinese medicine syndrome clinical efficacy:The total effective rate was 90.24% in the treated group, the total effective rate of the control group was 70%, compared the two groups was significant difference (P<0.01)3. TCM syndrome score:TCM syndrome score were decreased after the treatment There were significant differences,P<0.01. After treatment, the treated group oppression in the stomach duct and abdominal distention, poor appetite, fatigue and lack of strength, fatigued spirit and laziness to speak, dry mouth and bitterness in the mouth, exaction, agitation, and irascibility, nausea and vomiting, belching, thin sloppy stool was better than the control group. There were significant differences, P <0.01 or P<0.05.4. Biochemical response:After treatment,the ALT levels were significantly decreased compared with before treatment, P<0.01. As treatment time, the negative rate of ALT in both groups increased. ALT negative conversion rate was higher in treatment group, there is statistical difference, P<0.05 or P<0.01.5. Virological response:This study did not have the primary treatment failure patients. A total of 5 patients had virological breakthrough.All cases occurred in the control group. Three patients had M204I mutation, mutation was not detected in two patients. Compared with treatment group. There were significant differences, P<0.05. Treated group in 12th week,24th week,36th week,52nd week,HBVDNA negative conversion rates were:48.78%,75.61%,75.61%,85.37%; HBVDNA negative rate of the control group were 27.5%,47.5%,52.5%,60%, the two groups were statistically significant, P<0.01 or P<0.056. HBeAg serological response:HBeAg negative conversion rate and the rate of HBeAg seroconversion with treatment regimens increased the extension of the treatment group.After treatment,12th week,24th week,36th week,52nd week, HBeAg negative conversion rate and HBeAg seroconversion rates were 14.63% 2.44%,31.71%/24.39%,43.9%/31.71%,56.09%/43.9%; control group was 7.5%/ 0,10%/5%,20%/10%,30%/20%. Negative rate of HBeAg and HBeAg negative rate in 12th week, no significant differences between the two groups, P> 0.05; in 24th week,36th week,52nd week, the two groups were statistically significant, P<0.05.7. The liver histological response:A total of 49 patients (treatment group 28 cases,21 cases in control group) received twice liver histology before and after treatment. After treatment, liver inflammation grade, fibrosis stage were significantly decreased compared with before treatment, P<0.05 or P<0.01. After treatment, liver inflammation grade and fibrosis stage between the two groups showed no significant difference, P> 0.05.8. Adverse reactions:Elevated CK in both groups of patients,18(43.9%) patients in treatment group; control group of 30 cases, accounting for 75%, between the two groups were significantly different, P<0.01.Conclusion:Additional FuZheng SanXie Recipe combined with Telbivudine can significantly improve the TCM syndrome, inhibition of HBV replication, improve the rate of ALT normalization and HBeAg seroconversion rates, lower the incidence of virologic breakthrough, reduce the proportion of elevated serum CK,which was significantly better than Telbivudine monotherapy. Additional FuZheng SanXie Recipe combined with Telbivudine for HBeAg positive chronic hepatitis B Liver-qi with Deficient Spleen have better clinical efficacy, safety.