Clinical Study On Fangji Fuling Decoction In The Treatment Of Ascites Due To Hepatitis B Cirrhosis(Spleen Deficiency And Water Stagnation)

Objective:To evaluate the clinical efficacy and safety of Fangji Fuling Decoction in treating hepatitis B cirrhosis ascites in patients with spleen deficiency andwater-stagnation,and to explore the advantages of traditional Chinese medicine syndrome differentiation and treatment,in order to provide an effective new approach for the clinical treatment of hepatitis B cirrhosis ascites due to spleen deficiency and water stagnation type liver.Methods:Sixty patients with ascites due to hepatitis B cirrhosis(spleen deficiency and water stagnation)who met the inclusion criteria were selected and randomly divided into a control group(n=30)and an treatment group(n=30)using a random number table.The control group was treated with routine western medicine treatment,while the treatment group was treated with Fangji Fuling Decoction in addition to routine western medicine treatment for 4 weeks.The changes in TCM symptom scores,abdominal circumference,body weight,24-hour urine volume,liver fibrosis(HA,LN,PC III,IV-C),liver function(ALT,AST,TBIL,ALB),coagulation function(PT,PTA),renal function(BUN,SCr),serum sodium(Na~+),and ascites grading were observed and recorded for both groups before and after treatment.The clinical efficacy of the two groups was compared using the statistical software SPSS 25.0.Results:1.Analysis of TCM symptom efficacy:After treatment,the total effective rate in the treatment group was 90.00%,which was significantly higher than that in the control group(73.33%)(P<0.05).2.Analysis of comprehensive clinical efficacy:After treatment,the total effective rate in the treatment group was 86.67%,which was significantly higher than that in the control group(70.00%)(P<0.05).3.Comparison of abdominal circumference,body weight,24-hour urine volume,and ascites grading:After treatment,the abdominal circumference,body weight,24-hour urine volume,and ascites grading of both groups were significantly improved compared to before treatment(P<0.05),and the treatment group was superior to the control group(P<0.05).4.Comparison of liver function:After treatment,the liver function(ALT,AST,TBIL,ALB)of both groups was significantly improved compared to before treatment(P<0.05),and the treatment group was superior to the control group(P<0.05).5.Comparison of liver fibrosis:After treatment,the liver fibrosis(HA,LN,PC III,IV-C)of both groups was significantly decreased compared to before treatment(P<0.05),and the treatment group was superior to the control group(P<0.05).6.Comparison of coagulation function:After treatment,the coagulation function(PT,PTA)of both groups was significantly improved compared to before treatment(P<0.05).There was no statistically significant difference between the treatment group and the control group in improving the coagulation function of the patients after treatment(P>0.05).7.Comparison of renal function:After treatment,the renal function(BUN,SCr)of both groups was significantly improved compared to before treatment(P<0.05),and the treatment group was superior to the control group(P<0.05).8.Comparison of serum sodium:After treatment,the serum sodium(Na~+)of both groups was significantly increased compared to before treatment(P<0.05),and the treatment group was superior to the control group(P<0.05).9.Safety and efficacy:Before and after treatment,no significant abnormalities were found in general vital signs,stool routine,urine routine,and electrocardiogram in both groups of patients.In the treatment group and the control group,7 and 9 patients,respectively,showed slightly decreased white blood cell count,red blood cell count,and platelet count in blood routine,which was considered to be caused by splenomegaly due to hepatitis B cirrhosis and could be restored to normal after symptomatic treatment.No adverse events occurred in either group during the treatment process.Conclusions:Fangji Fuling Decoction has a definite therapeutic effect in ascites with hepatitis B cirrhosis ascites due to spleen deficiency and water-stagnation.It can effectively improve the TCM symptom score,abdominal circumference,body weight,24-hour urine volume,four liver fibrosis markers(HA,LN,PCⅢ,Ⅳ-C),liver function(ALT,AST,TBIL,ALB),renal function(BUN,SCr),serum sodium(Na~+),ascites grading,alleviate clinical symptoms,reduce ascites,stabilize the disease,and is worth promoting for clinical use.