| Objective:To observe the clinical effect of Hai Zhu Yi Gan Hua Xian Fang adds flavour treatment of Hepatitis B liver cirrhosis compensatory period(qi stagnation and blood stasis),and evaluate its safety.Methods:Select 60 patients who met the inclusion criteria for Hepatitis B cirrhosis compensatory period(qi stagnation and blood stasis syndrome),and these patients were admitted to the Department of Liver Diseases,the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine,A randomized,1:1 design was used to divide patients into treatment and control groups,30 patients in each group.Before treatment,the two groups of patients were compared in terms of gender,age,and disease duration,The results showed the difference was not statistically significant(P<0.05),The comparison between the two groups is similar.In the control group,oral entecavir dispersible tablets were orally administered once daily,0.5 mg/time,and taken on an empty stomach.The treatment group was treated with Haizhu Yigan Huaxianfang adds flavour,based on the control group,and the observation period is 12 weeks in both groups.Recorded changes in symptom scores,Liver fibrosis index,liver function,liver and spleen B-value and FS value before and after treatment.And observe possible adverse reactions to drugs.Then compare the comprehensive efficacy of the treatment group and the control group after treatment,then,we evaluated the clinical efficacy of Haizhu Yigan Huaxianfang adds flavour on patients with compensated period of cirrhosis of hepatitis B(qi stagnation and blood stasis syndrome),and evaluate its safety.Results:1 、 After the treatment,the total effective rate of the clinical comprehensive curative effect was 83.33%,and the total effective rate of the control group was 60%,and the difference between the two groups was statistically significant(P<0.05).The clinical comprehensive efficacy of the treatment group was better than that of the control group after treatment.2、TCM symptom scores decreased in both groups after treatment,and comparison two groups between before and after treatment,and the difference between the two groups was statistically significant(P<0.05);Comparison between the treated group and the control group,the difference between the two groups was statistically significant(P<0.05),After treatment,the clinical symptoms and physical fitness of both groups are improved.And the treatment group improved more significantly than the control group.3 、 After the treatment,the liver function of both groups was improved,and The difference between the two groups before and after treatment was statistically significant(P<0.05),after treatment the difference between the treatment group and the control group was statistically significant(P<0.05).After treatment,the liver function of the two groups was improved.Compared with the groups,the improvement of liver function in the treatment group was better than that in the control group.4、After treatment,both liver fibrosis indexes and FS values decreased in both groups,comparing the patients before and after treatment in both groups,the liver fibrosis indexes and FS values after treatment decreased,and The difference between the two groups before and after treatment was statistically significant(P<0.05).Comparison between treatment group and control group after treatment,The difference was statistically significant(P<0.05).The results showed that the four indicators of liver fibrosis and the FS values were reduced after treatment in both groups,Compared with the control group,the treatment group was significantly lower than the control group.5、The liver and spleen B-values of the two groups were reduced after treatment,and after treatment within the group,the difference was statistically significant(P<0.05).Comparison between treatment group and control group after treatment,The difference was statistically significant(P<0.05).The results showed that after treatment,liver and spleen B values were reduced in both groups.And after treatment,the liver and spleen B-values in the comparative treatment group were more significantly reduced than those in the control group.6、Safety evaluation:During the treatment period,there were no obvious abnormalities in the safety indicators of the two groups and no adverse events or adverse reactions occurred.Conclusions: 1、Haizhu Yigan Huaxianfang adds flavour can reduce liver fibrosis(HA,PCIII,IV-C,LN)indexes and liver FS test values of patients with hepatitis B liver cirrhosis at compensatory stage(qi stagnation and blood stasis syndrome),and reduce the degree of fibrosis,Haizhu Yigan Huaxianfang adds flavour has anti-fibrotic effect.The efficacy of Haizhu Yigan Huaxianfang adds flavour is better than that of entecavir alone.The results suggest that Haizhu Yigan Huaxianfang adds flavour can alleviate the progression of cirrhosis.2 、 Haizhu Yigan Huaxianfang adds flavour can effectively reduce the serum ALT,AST,TBIL indicators,improve portal hypertension.3、Haizhu Yigan Huaxianfang adds flavour improved clinical symptoms and signs of patients better than simple entecavir antiviral therapy. |