| Objective: In this study,we observed the clinical efficacy of self-made Kangxian decoction combined with entecavir in patients with hepatitis B liver fibrosis due to qi stagnation and blood stasis syndrome,and explored the possible mechanism of its improvement of liver inflammation,so as to provide scientific basis for the treatment of liver fibrosis due to hepatitis B with traditional Chinese medicine.Methods: A total of 71 hepatitis B liver fibrosis patients with the syndrome of qi stagnation and blood stasis who met the inclusion criteria were enrolled between January2020 and January 2021,who visited the outpatient clinics or were hospitalized in the Department of Gastroenterology of Fuzhou second hospital,and were randomly divided into two groups,36 in the control group and 35 in the test group.The control group was treated with entecavir alone,and the test group was treated with self-made Kangxian decoction combined with entecavir.The treatment lasted for 24 weeks.The change scores of TCM syndrome,liver function(ALT,AST,GGT),HBV DNA load,LSM of patients were observed and recorded before treatment,12 th and 24 th weeks of treatment,TGF-β 1,IL-6,IL-10 were measured before treatment,24 th week of treatment.The above data were statistically analyzed by SPSS20.0 software.Results:(1)Comparison of the efficacy of TCM: at the 24 th week of treatment,the total effective rate was 97.1% in the test group and 80.6% in the control group,and the total effective rate in the test group was significantly better than that in the control group(P <0.05).(2)Comparison of TCM syndrome scores: the TCM syndrome scores of patients in both groups at the 12 th and 24 th weeks of treatment were decreased compared with those before treatment(P < 0.05),and the test group was superior to the control group(P < 0.05).(3)Comparison of liver function: ALT,AST and GGT in both groups at the 12 th and 24 th week of treatment were decreased compared with those before treatment(P < 0.05),and the test group was superior to the control group(P < 0.05).(4)Virological comparison: there was no significant difference in HBV DNA negative conversion rate between the two groups at the12 th and 24 th week of treatment(P > 0.05).(5)Comparison of liver stiffness values: at 12 and24 weeks of treatment,LSM in both groups decreased compared with that before treatment(P< 0.05),and the test group was superior to the control group(P < 0.05).(6)Comparison of TGF-β 1: at the 24 th week of treatment,TGF-β 1 in both groups decreased significantly compared with that before treatment(P < 0.05),and the test group was superior to the control group in reducing TGF-β 1(P < 0.05).(7)Correlation analysis between TGF-β 1 levels and LSM: TGF-β 1 levels were positively correlated with LSM(P < 0.05).(8)Comparison of IL-6,IL-10: at the 24 th week of treatment,IL-6 and IL-10 in the two groups decreased significantly compared with those before treatmen(P < 0.05),and IL-6 and IL-10 in the test group were lower than those in the control group(P < 0.05).(9)Correlation analysis between the levels of IL-6 and IL-10 with ALT,AST and GGT: There were significant positive correlations between IL-6 and ALT,AST and GGT(P < 0.05).There were significant correlations between IL-10 levels and ALT and AST(P < 0.05),but no correlation between IL-10 levels and GGT levels(P > 0.05).(10)During the whole process of the trial,no obvious abnormalities in the safety indicators between the test group and the control group were observed,and no adverse reactions occurred.Conclusion: In terms of clinical efficacy,the combination of self-made Kangxian decoction and entecavir had the effects of alleviating the clinical symptoms,improving the liver function,and reducing the degree of liver fibrosis in patients.Secondly,the above mechanism of the improved efficacy might be related to the reduction of hepatic inflammation in patients with self-made Kangxian decoction. |
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