The Clinical Study Of Rougan Sanjie Pills Combined With Entecavir In The Treatment Of Hepatitis B Liver Cirrhosis In The Compensatory Phase(Blood Stagnation Syndrome)

Objective:To evaluate the clinical efficacy and safety of Rougan Sanjie Pills in the treatment of patients with hepatitis B liver cirrhosis in the compensatory phase(blood stagnation syndrome).Methods:The subjects of this study were all from the outpatients of the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine from March 2020 to October 2020 who met the diagnostic criteria for hepatitis B liver cirrhosis in the compensatory period(blood stagnation syndrome);the study subjects were divided into 3 groups: control group A,control group B and treatment group,30 cases in each group.Control group A was treated with placebo combined with entecavir,control group B was treated with Fuzheng Huayu capsule combined with entecavir,and the treatment group was treated with Rougan Sanjie Pills combined with entecavir.The three groups of treatment courses are all 12 weeks.Comparison before and after treatment of the TCM Syndrome Points,TCM Syndrome Efficacy,serum inflammatory factors(TNF-α,IL-6,IL-22)levels,liver function indexes(ALT,AST,TBi L,ALB),blood coagulation function(PTA),liver stiffness value(LSM),liver,gallbladder,spleen and pancreas ultrasound(inner diameter of portal vein,spleen length,spleen thickness)and occurrence of decompensation rate.Results:(1)After the treatment,the efficacy of TCM syndromes in each group:the total effective rate of the treatment group was 90.0%,the total effective rate of the control group A was 56.67%,and the total effective rate of the control group B was 83.34%,and the treatment group was significantly better than the two control groups(P<0.05).In terms of improving the TCM syndrome score,the difference between the treatment group and the control group A was statistically significant(P<0.05),and the difference between the treatment group and the control group B was not statistically significant(P>0.05).(2)The changes of serum inflammatory factors,the levels of TNF-α,IL-6,and IL-22 in the three groups were all decreased compared with before treatment,and the difference was statistically significant(P<0.05);In terms of improving the levels of TNF-α and IL-6,the difference between the treatment group and the two control groups was statistically significant(P<0.05);in terms of improving IL-22,the difference between the treatment group and the control group A was statistically significant Significance(P<0.05),there was no statistically significant difference between the treatment group and the control group B(P>0.05).(3)Changes in liver function indicators,ALT,AST,and TBi L of the three groups of patients decreased compared to before treatment(P<0.05),and the decrease in the treatment group was more significant than that of the two control groups,and the difference was statistically significant(P<0.05);However,there was no significant difference in the improvement of ALB between the three groups of patients than before treatment(P>0.05).(4)The changes in liver stiffness and coagulation function,the LSM and PTA levels of the three groups of patients were lower than before treatment,the difference was statistically significant(P<0.05);the three groups improved LSM and PTA,the treatment group was compared with the control group A,The difference was statistically significant(P<0.05),and the difference between the treatment group and the control group B was not statistically significant(P>0.05).(5)The changes of liver,gallbladder,spleen,and pancreas by ultrasound,the portal vein diameter,spleen length,and width of the three groups were not significantly different from those before treatment,and there were no significant differences between and within groups in each group(P>0.05).(6)The occurrence of decompensation rate,the decompensation rate of the treatment group is 3.34%,the decompensation rate of the control group A is10.0%,and the decompensation rate of the control group B is 6.67%;there is no difference between the treatment group and the two control groups Statistically significant(P>0.05).Conclusions: The clinical efficacy of Rougan Sanjie Pills combined with Entecavir in the treatment of patients with hepatitis B cirrhosis in the compensatory stage(blood stagnation syndrome)is better than that of the control group treated with Western medicine alone and Western medicine combined with Fuzheng Huayu Capsules,and Its mechanism of action may be related to the regulation of the expression of inflammatory factors by the prescription.