Clinical Effect And Virological Effect Of Yinhuang Qingmu Mixture Intervene On Hepatitis B Immune Tolerance

Objective:To observe the clinical efficacy and virological effects of our hospital's homemade Chinese herbal compound Yinhuang Qingmu mixture interfering with chronic hepatitis B virus carriers in immune tolerance period,to seek safe and effective Chinese medicine treatment methods for chronic hepatitis B virus carriers during the immune tolerance period.Methods:1.Grouping methods:80 patients with chronic hepatitis B virus who were diagnosed as immunotolerant in Wuhan Integrative Medicine Hospital and met the inclusion criteria were randomly divided into two groups,namely Yinhuang Qingmu mixture treatment group and the tiger foal second liver capsule positive control group.2.Treatment plans:In the control group,the tiger foal second liver capsule was taken orally(produced by Jiangsu renshou pharmaceutical co.LTD.)0.2 g/grains,1 g/time,taken the drug with warm water after 30 minutes of the meal,three times in one day.In the treatment group,Yin Huang Qing Mu mixture was taken orally.(drug composition:capillaris,astragalus,polygonum cuspidatum,angelica,Houttuynia cordata,Codonopsis pilosula,vinegar corydalis,fry medlar,Banlangen,Bupleurum,Tianji yellow,purple flower Ding,Hedyotis diffusa,Zhigancao,honey,once in the morning and evening,50ml each time).Both courses of treatment are12 weeks.The withdrawal was followed up for 12 weeks.3.Observed indicators:Observe the changes of main symptom scores,liver function indexes(including ALT,AST,?-GT,TBIL,DBIL),hepatitis B virus DNA load and hepatitis B virus serological markers(HBeAg)before and after treatment and after stopping for12 weeks,then according to the corresponding efficacy evaluation criteria,make a curative effect evaluation.And observe the adverse reactions during the treatment.4.Statistical methods:SPSS 20.0 statistical software was used for statistical analysis of the data,and all data were recorded.The difference was statistically significant at P<0.05.P<0.01was obviously statistically significant.P>0.05 was not statis-tically significant.The comparison of count data rates uses the?~2 test.Measured data were expressed as mean±standard deviation((?)±s),and t test was used for comparison between groups.Results:1.Comprehensive evaluation of curative effect:After 12 weeks of treatment,the total effective rate of TCM symptoms in the treatment group was 87.50%,and that of the control group was 65.00%.Statistical analysis showed that the difference between the two groups was significant(P<0.05).TCM symptom of the TCM treatment group was observed at the follow-up for 12 weeks.The total effective rate was 90.00%,while the control group was only 67.50%.There was a statistically significant difference between the two groups(P<0.05).2.The scores of individual TCM symptom scores were compared:After treatment,all symptom scores in the treatment group were significantly lower than those before treatment(P<0.01).There was no significant difference in symptom scores between the follow-up period and the end of treatment(P>0.05).In the control group,only the symptoms of hypochondriac pain did not show statistical differences before and after treatment(P>0.05),and the remaining symptoms were all relieved.The difference between the two groups before and after treatment was statistically significant(P<0.05).The individual follow-up scores for each follow-up period were 12 weeks.Compared with the end of the treatment period,there was no significant difference(P>0.05).After treatment,there was a statistically significant difference between the two groups in each single symptom score(P<0.05).3.Comparison of total symptom scores of traditional Chinese medicine:The total scores of TCM symptoms before treatment in the two groups were determined by two independent samples mean t test,with no statistical difference(P>0.05).After 12 weeks of treatment,the total scores of TCM symptoms in the treatment group and the control group were 5.48±2.80 and 7.68±2.76,respectively,which showed significant statistical differences compared with before treatment(P<0.01);The TCM symptom scores in the treatment group decreased significantly better than the control group(P<0.05).There was no significant difference in the TCM symptom scores at the end of the 12-week follow-up between the two groups and at the end of the treatment period(P>0.05).There was a statistically significant difference between the two groups(P<0.05).4.Changes in Liver Function Index:There were no significant differences in liver function indexes such as ALT,AST,?-GT,TBIL and DBIL between the two groups before and after treatment and 12weeks after stopping treatment(P>0.05).There was no significant difference in liver function indexes of ALT,AST,?-GT,TBIL,DBIL between the two groups after treatment and 12 weeks of follow-up(P>0.05).5.The comparison of HBV-DNA load changes:There was no significant difference in HBV-DNA levels between the two groups before treatment.The difference of HBV-DNA levels between the two groups after treatment for 12 weeks and after 12 weeks of withdrawal was statistically significant(P<0.05).There was no significant difference in HBV-DNA levels between the two groups after treatment for 12 weeks and the 12 weeks follow-up visit(P>0.05).6.Comparison of changes in HBeAg negative:After 12 weeks of treatment and after 12 weeks of treatment,the HBeAg turnover was compared in 40 cases in the treatment group,one cases of HBeAg negative after 12 weeks of treatment,and one case of negative in the control group.During the follow-up period of 12 weeks,HBeAg was negative in the treatment group has two patients and one control group.No HBeAg seroconversion occurred in both groups during the entire course of treatment and follow-up.There was no significant difference in HBeAg negative status between the two groups after12 weeks of treatment and after 12 weeks of withdrawal(P>0.05).7.Safety evaluation:The total number of patients enrolled in the study was 80 cases.The safety indicators of the patients were examined before and after treatment(hematuria,feces,coagulation function,liver and gallbladder,etc.),and there were no significant changes in safety indicators before and after treatment.All patients completed 12 weeks of treatment,and only 2 patients felt mild nausea after taking the drug,but they were all able to tolerate.No other adverse reactions and toxic side effects occurred in other cases.Conclusion:After randomized controlled clinical observation,the intervention of Yinhuang qingmu mixture for chronic hepatitis B virus carriers during immune tolerance period can effectively improve some of the patients'symptoms and signs,reduce the viral load of HBV-DNA,and have obvious antiviral effect.high.This study confirms that the traditional Chinese medicine compound Yinhuang Qing Mu mixture intervenes safely and effectively in the state of hepatitis B immune tolerance,and can provide a more useful treatment for clinics,which makes up for the lack of modern medical treatment for hepatitis B immune tolerance.