Clinical Study On Ruanganfang For Treating Chronic Hepatitis B Patients With Compensated Liver Cirrhosis (Liver And Spleen Of Blood Stasis Syndrome)

Objective: To observe the clinical effect of ruanganfang combined with entecavir for treating the chronic hepatitis B patients with compensated liver cirrhosis(liver and spleen of blood stasis syndrome)and the safety of medication.Methods: According to the inclusion criteria,gathering 60 cases of chronic hepatitis B patients with compensated liver cirrhosis was divided into two groups.With the random control method,30 cases were devided into the treatment group;the rest 30 cases were devided into the control group.56 cases were finally completed the trial,27 cases in the treatment group and the 29 cases in the control group.Both groups were given entecavir dipivoxil protect the liver and symptomatic conventional treatment on the basis of long-term treatment of 0.5 mg/d treatment group in the control group on the basis of jointly taking Ruanganfang once day.3 months made one cause of treatment for both of them.Liver function,liver fibrosis markers(HA,LN,and ?-C),abdominal ultrasonographic measurements(portal vein diameter,thickness of spleen,and splenic vein width),HBV DNA and liver Fibroscan value(FS value)were observed.The data were analyzed by t test and X2 test and Rank sum test with SPSS19.0.Results: The clinical research shows that: The total effective rate of the treatment group was 70.37% and had statistical significance compared with the control group(P<0.05).The total TCM effective rate of the treatment group was 81.48% and had statistical significance compared with the control group(P<0.05).The treatment group can obviously improve the clinical symptoms and signs such as hypochondriac pain,abdominal distention,and abdominal lump,especially for lassitude and poor appetite,with significant difference statistically significant(P<0.05).The value of HA and LN and ?-C of both groups decreased obviously pre and post treatment.The decreased value of ?-C and HA and LN of the control group were obviously lower than those of the treatment group and had statistical significance(P<0.01).The value of AST and ALT decreased obviously after treatment,the value of A/G increased obviously.The difference value of AST and ALT and TBIL and A/G of the both groups had statistical significance after treatment(P<0.01).The results of B-ultrasonic of main portal vein diameter and spleen diameter and splenic vein diameter improved obviously,but there was no statistical significance between the both groups after treatment(P>0.05).The HBV DNA of the two groups were significantly lower after treatment(P<0.05).but there was no statistically significant difference between the two groups after treatment(P>0.05).Safety index: The safety index of two groups before and after treatment had no abnormal changes;patients of two groups didn't suffer adverse events and adverse reactions.Conclusion(s): The result of clinical observations shows: Compared with the treatment in using Entecavir only,the effect afer the treatment in using both ruanganfang and entecavir is much better: it can obviously decreased liver fibrosis(HA,LN,and ?-C)levels and liver FS,against or ease the liver fibrosis or cirrhosis,and improve the efficiency of treatment.Moreever,Ruanganfang can effectively reduce ALT,AST,TBIL level,and improved A/G level.The effect of ruanganfang was better than simple entecavir antiviral treatment on improved the clinical symptoms and signs.