Clinical Studies Of Hepatitis B The Changle Tablets In The Treatment Of Chronic Hepatitis B (liver And Spleen Damp-heat Syndrome)

ObjectiveTo observe the effect of Yiganchangle tablet on patients of liver-spleen dampness-heat syndrome with chronic hepatitis B. Meanwhile this research try to investigate the functional mechanism of Yiganchangle Tablet and provide scientific clinical basic for its product and use.MethodsChoose the patients of liver-spleen dampness-heat syndrome with chronic hepatitis B as observing objects.Seventy cases were randomly divided into 2 groups,each 35,one for treatment and the other for control,observed by double blind method. For treatment group,treated by Yiganchangle tablet,otherwise in control group,Compound pill for Nourishing Liver was used.The treatment course of this research is 12 weeks,3 months for the follow-up visit.The study was designed to investigate the changes of clinical syndrome,physical sign,liver function before and after the treatment by physical and lab test.Observing change of the clinical symptom physical sign,Traditional Chinese medicine syndrome integral,Hepatic function(concluding ALT,AST,Tbil,DbiL,ALP,GGT,ALB and GELO),HBV-M,HBV-DNA quantity,B supersonic wave on liver and spleen,and secure index(concluding blood,urine,stool routine and renal function,ECG),comparing the tharapeutic efficacy of both drugs.Results1.The curative effect of enzyme dropping:The treated group: clinical cured rate is 34.3%,obvious effective rate is 57.1%,total effective rate is 97.1%;The controlled group:clinical cured rate 20.6%,obvious effective rate is 47.1%,total effective rate is 85.3%. The effective rate of treated group was better than that of the controlled group,but there aren't statistics difference between two groups(P＞0.05)2.The curative effect of traditional Chinese medicine syndrome:The treated groups:obvious effective rate is 91.4%,total progressive rate is 97.1%;The controlled group:obvious effective rate is 76.5%,total effective rate is 91.2%.The effective rate of treated group was better than that of the controlled group,but there aren't statistics difference between two groups(P＞0.05).3.The curative effect of TBi1,DBi1:The treated groups:obvious effective rate is 25.7%,total progressive rate is 60.0%;The controlled group:obvious effective rate is 14.7%,total effective rate is 41.2%. The effective rate of treated group was better than that of the controlled group,but there aren't statistics difference between two groups(P＞0.05)4.The curative effect of blood plasma albumen:There are obvious progress on two groups in the end of experiment(P＜0.05),but there isn't statistics difference between two groups(P＞0.05).5.The safety index:the two groups were not discovered adverse reaction and harmful effect on cases.There was not abnormal change on blood,urine,stool routine and renal function,ECG of cases.Conclusion:Yiganchangle tablet have the same curative effect on chronic hepatitis B of liver-spleen dampness-heat syndrome as the Compound pill for Nourishing Liver,and its long-term curative effect is better than the compared drug.Yiganchangle tablet can well improve symptom and physical sign of the patients of liver-spleen dampness-heat syndrome with chronic hepatitis B,progress Hepatic function,lighten the damage of liver.It have not the serious side effects in this clinical research.The Yiganchangle Tablet is the effectual and secure medication to liver-spleen dampness-heat syndrome with chronic hepatitis B from the research.