| Objective To observe the clinical efficacy of Rougan Huaxian Granule in the treatment of decompensated Hepatitis B cirrhosis and evaluate its safety.Methods Sixty patients with decompensated liver and kidney yin deficiency syndrome who met the inclusion criteria were randomly divided in to the control group(n=30)and the treatment group(n=30).The control group was treated with entecavir dispersible tablets on the basis of comprehensive medical treatment of western medicine.The treatment group was treated with Rougan Huaxian Granules on the basis of the control group.The two groups were treated for 12 weeks.Liver function(ALT,AST,ALB,TBIL),coagulation function(PT),blood routine(WBC,RBC,Hb,PLT),liver and spleen ultrasound,ascites grading,TCM symptoms were recorded before treatment and 12 weeks after treatment.The scores and other changes were used to evaluate the clinical efficacy and safety of Rougan Huaxian Granules in the decompensation of hepatitis B cirrhosis.Results(1)After treatment for 12 weeks,ALT,AST,ALB and TBIL were improved compared with those before treatment(P<0.05),and the treatment group was better than the control group(P<0.05);(2)12 weeks after treatment,The PT of the two groups were lower than that before treatment(P<0.05),and the treatment group was better than the control group(P<0.05).(3)After 12 weeks of treatment,the WBC and PLT of the two groups were increased compared with those before treatment.(P<0.05),the treatment group was better than the control group(P<0.05).After treatment for 12 weeks,the control group had no difference in RBC and HB compared with before treatment(P>0.05).The treatment group received RBC,HB and before treatment.Compared with the control group(P<0.05),the treatment group was superior to the control group(P<0.05).(4)After 12 weeks of treatment,the portal vein diameter,spleen thickness and spleen length were compared with the anterior phase.The reduction was better(p<0.05);the treatment group was better than the control group(P<0.05);(5)after 12 weeks of treatment,the ascites grading of the two groups was improved compared with that before treatment(P<0.05).The improvement was better than the control group(P<0.05).(6)After 12 weeks of treatment,the TCM syndrome scores of both groups decreased(P<0.05).And the score of the treatment group decreased better than the control group(P<0.05).(7)After 12 weeks of treatment,the total effective rate of the treatment group was 83.33%,and the total effective rate of the control group was 67.86%.The overall efficiency of the treatment group was better than that of the control group(P<0.05).(8)There were no obvious adverse reactions during the treatment of the two groups of patients.Conclusions(1)Rougan Huaxian Granules in the treatment of decompensated liver of hepatitis B cirrhosis can reduce liver damage,improve liver synthesis and improve blood coagulation;(2)Rougan Huaxian Granule can alleviate the symptoms of portal hypertension,improve the symptoms of hypersplenism and reduce the amount of ascites;(3)Rougan Huaxian Granules can improve the clinical symptoms of patients,improve the overall efficacy of treatment,and is safe. |