Addition And Subtraction Of Gan Lu Xiao Du Pill By The Treatment Of Chronic Hepatitis B (Liver And Gallbladder Damp-heat Syndrome) Clinical Study

ObjectiveTo observe the clinical effect and safety of addition and subtraction of Gan lu xiao du pill on patients of damp heat in liver and gallbladder with chronic hepatitis B.This research try to investigate the functional mechanism of addition and subtraction of Gan lu xiao du pill and provide scientific clinical basic for its product and use.Method48 patients diagnosed with HBV all came from the Liver Disease Center of Hu Bei Hospital of TCM from the January 2008 to the January 2009.All cases TCM syndrome was damp heat in liver and gallbladder.The cases were divided into 2 groups randomly,24 cases were served as observed group and treated by "addition and subtraction of Gan lu xiao du pill",the other 24 cases were served as control group and treated by "Zhang yin chen tablet".Both of the groups were 3 months for the course of treatment,3 months for the treatment follow - up visit.Observing the clinical symptom physical sign,TCM syndrome integral,Hepatic function(ALT,AST,GGT,TBIL),liver spleen B surpersonic wave change and safe index(blood,urine, routine and renal function,EGG).Results1.The cases selected:There were 48 patients(24 of the observed group,24 of the control group) treated completely to press the research project for 3 month.All cases were respectively with follow-up visit for 3 month.2.Synthetic therapeutic effect and TCM syndrome therapeutic effect in clinic:after 3months' treatment,comparing synthetic therapeutic effect in clinic,for the observed group,the excellence rate was 37.5%,the total effective rate was 75.0%.for the control group,the excellence rate was 12.5%,the total effective rate was 45.8%,there were significant difference between 2 groups(P＜0.05).comparing TCM syndrome therapeutic effect,for the observed group,the recovery rate was 16.7%,the total effective rate was 79.2%,for the control group,the recovery rate was 4.2%,the total effective rate was 37.5%.There was significant difference between 2 groups (P＜0.05).3.TCM syndrome integral change:after 3 months' treatment the integral was obviously decreased in the 2 groups.Comparing with the control group,the integral of the observed group was obviously decreased(P＜0.05).4.Hepatic function change:after 3 months' treatment,the hepatic function(ALY,AST,GGT,TBIL)were obviously decreased in the 2 groups.Comparing with the control group,the hepatic function of the observed group were obviously decreased(P＜0.05).5.The safe index:the two groups did not discover adverse reaction.In therapy AP detecting blood,urine,stool routine and renal function,ECG and so on,did not discover clinical abnormal change about medication.Conclusion1.The addition and subtraction of Gan lu xiao du pill and Zhang yinchen tablet could well improve symptom,physical sign of patients with HBV,depress the level of abnormal hepatic function,lighten the damage of liver,but the addition and subtraction of Gan lu xiao du pill obviously surpassed to Zhang yin chen tablet.Comparing to the synthetic therapeutic effect and TOM syndrome therapeutic effect in clinic,the total effective rate of addition and subtraction of Gan lu xiao du pill was obviously better than Zhang yin chen tablet.2.The clinical safety of addition and subtraction oGan lu xiao du pill was good,did not discover adverse reaction about investigation drug,there were not harmful effects on blood,urine,stool routine and renal function,ECG of patients with HBV.