| Objective: To observe the clinical efficacy and safety of Jiawei Xiaoyao Powder in treating patients with liver depression and spleen deficiency syndrome of hepatitis B cirrhosis by carrying out a randomized controlled clinical study.Methods: In this study,60 patients diagnosed with hepatitis B cirrhosis(syndrome of liver depression and spleen deficiency)were included,and the control group and the treatment group were each divided into 30 cases using a randomized controlled study method.The control group was treated with entecavir capsules under the premise of western medicine basic comprehensive treatment,while the treatment group was treated with Jiawei Xiaoyao Powder on top of the control group for a total duration of 12 weeks.Before and after treatment,the efficacy score of TCM symptoms,liver stiffness value(LSM),liver function(ALT,AST),albumin(ALB),hepatitis B DNA(hepatitis B virus-DNA,HBV-DNA)level,four liver fibrinograms(HA,PCIIINP,IV-C,LN)and haemodynamics were observed in the two groups.Results:1.In the analysis of the TCM symptom scores and comprehensive efficacy,at the end of the treatment course,the TCM symptoms such as fatigue,pain in the ribs,loss of appetite,dry mouth and bitterness were better in both groups than before(P < 0.05),and the difference was statistically significant;at the end of the treatment,the TCM symptom scores decreased more significantly in the treatment group than in the control group(P < 0.05),and the difference was statistically significant.2.Analysis of liver function(AST,ALT,ALB)results,at the end of the treatment course,the AST,ALT and ALB levels of both groups decreased compared with those before treatment(P < 0.05),and the difference was statistically significant;compared between groups,the decrease in AST,ALT and ALB levels was more significant in the treatment group than in the control group after treatment(P < 0.05),and the difference was statistically significant.3.Analysis of the hepatitis B virus DNA results,at the end of the course of treatment,the HBV-DNA values of both the control and treatment groups were significantly lower than before(P < 0.05),and the difference was statistically significant;however,there was no significant difference in HBV-DNA values between the two groups compared to each other(P > 0.05),and the difference was not statistically significant.4.Analysis of the results of the four liver fibrils(HA,PCIIINP,IV-C,LN),at the end of the course of treatment,the levels of the four liver fibrils in both the control group and the treatment group were significantly lower than before(P < 0.05),and the difference was statistically significant;compared between the two groups,at the end of the course of treatment,the levels of HA,PCIIINP,IV-C and LN decreased more significantly in the treatment group than in the control group(P < 0.05)The difference was statistically significant.5.Analysis of the liver hardness value(LSM)results showed that at the end of the treatment course,the LSM values of both the treatment and control groups decreased significantly(P < 0.05)compared to the previous ones,and the difference was statistically significant;compared between the two groups,the decrease was greater in the treatment group compared to the control group(P < 0.05),and the difference was statistically significant.6.Analysis of the changes in haemodynamic indexes,at the end of the treatment course,the indexes of abdominal ultrasound(splenic vein internal diameter(DSV),portal vein internal diameter(DPV),portal venous flow velocity(VPV)and portal venous flow(QPV))were detected and showed that,compared with the pre-treatment period,the DPV and DSV decreased insignificantly in both groups after treatment,and the difference was not statistically significant(P > 0.05),after treatment in both groups The patients’ VPV and QPV increased significantly after treatment(P < 0.05),and the difference was statistically significant.For comparison between groups,the difference in DPV and DSV values before and after treatment was not significant(P > 0.05),and the difference was not statistically significant.For the comparison of VPV and QPV values between the two groups,the increase in the treatment group was more significant than that in the control group(P <0.05),and the difference was statistically significant.Conclusions: Jiawei Xiaoyao Powder can improve liver function(ALT,AST,ALB)and four liver fibre indices(HA,PCIIINP,IV-C,LN)in patients with hepatitis B cirrhosis with liver depression and spleen deficiency,as well as reduce liver stiffness value(LSM)and improve portal venous flow velocity(VPV),portal venous flow(QPV)and other haemodynamic indices.It has been preliminarily confirmed that the development of liver cirrhosis(syndrome of liver depression and spleen deficiency)can be delayed to a certain extent and the clinical symptoms of the patients can be improved with the addition of Jiawei Xiaoyao Powder. |