A Clinical Study On Diwuyanggan Capsule In Treating HBeAg-negative Chronic Hepatitis B

Objective:To study the effectiveness and safety of Diwuyanggan capsule in treating HBeAg-negative chronic hepatitis B.Methods:We chose patients from the hospital in hubei province between January2011and April2013in liver disease outpatient service, the144cases of HBeAg negative chronic hepatitis B patients were randomly divided into three groups:Diwuyanggan capsule treatment group, antiviral treatment group,Diwuyanggan capsule combined with antiviral treatment group,each group was respectively given Diwuyanggan capsule, antiviral and Diwuyanggan capsule with antiviral therapy, treatment time was12months. We monitored groups before and after treatment in patients with HBV DNA, liver function(ALT,AST,GGT and ALP,TP,ALB,GELO,A/G,TBIL, IBIL and DBIL)and liver histological pathology,and observed changes of the security index (blood, urine and dung routine, renal function and electrocardiogram).Results:(1)Effect on HBV DNA replication:Into the group,Diwuyanggan capsule treatment group, antiviral treatment group, Diwuyanggan capsule combined with antiviral treatment group, patients with HBV DNA positive viral load were1.59×105±5.72×105、4.03×104±7.39 ×105、8.01×106±2.69×107, respectively, comparison between each group, after statistics processing, there was no significant difference, P>0.05. After12months’ treatment,HBV DNA viral load of antiviral treatment group (5.96×103±8.95×103) decreases, but the three groups, respectively, compared with HBV DNA viral load before the treatment, after statistics processing,there was no significant difference, P>0.05. After the treatment, comparison between three groups, after statistics processing,there was no significant difference, P>0.05.(2)Effects on biochemical indexes:into the group, ALT, AST, GGT and ALP detection results:Diwuyanggan capsule treatment group (34.00±14.93、28.52±7.79、19.74±14.13、61.81±16.20),antiviral treatment group (39.47±20.33、30.14±7.98、28.20±19.40、67.57±26.49),Diwuyanggan capsule combined with antiviral treatment group (38.50±22.08、29.78±12.88、28.41±23.32、71.61±21.93),after statistics processing,there was no significant difference among three groups, P>0.05. After12months’treatment, ALT, AST, GGT and ALP detection results:Diwuyanggan capsule treatment group (30.41±14.30、27.00±8.04、24.22±12.84、67.81±19.54),antiviral treatment group(25.34±9.2227.43±14.50、76.87±25.90), Diwuyanggan capsule combined with antiviral treatment group (35.97±62.32、26.93±32.71、24.97±14.98、75.90±22.56), groups, respectively, compared with before treatment, after statistics processing, the difference was not significant, P>0.05. After statistics processing,there was no significant difference among three groups, P>0.05.Into the group, TBIL、DBIL、IBIL detection results:Diwuyanggan capsule treatment group (13.93±5.90、3.29±2.11 10.64±4.06),antiviral treatment group (12.40±5.94、3.20±1.54、9.90±4.25),Diwuyanggan capsule combined with antiviral treatment group (13.96±10.11、3.41±2.43、10.55±7.82),after statistics processing,there was no significant difference among three groups, P>0.05.After12months’ treatment,TBIL,DBIL,IBIL detection results:Diwuyanggan capsule treatment group(12.70±7.57、4.02±2.72、8.68±5.10), antiviral treatment group (12.87±4.96、3.65±1.59、9.22±3.83),Diwuyanggan capsule combined with antiviral treatment group (11.19±6.75、3.74±1.36、7.46±5.92), groups, respectively, compared with before treatment, after statistics processing, the difference was not significant, P>0.05. After statistics processing,there was no significant difference among three groups, P>0.05.Into the group, TP、ALB、GELO、A/G detection results:Diwuyanggan capsule treatment group (71.70±4.55、43.51±3.09、28.18±3.38、1.57±0.22),antiviral treatment group (66.57±20.25、40.12±12.55、26.12±8.47、1.46±0.50),Diwuyanggan capsule combined with antiviral treatment group (72.86±4.12、43.78±2.59、29.08±2.91、1.52±0.18), after statistics processing, there was no significant difference among three groups,P>0.05. After12months’treatment,TP,ALB,GELO,A/G test results:Diwuyanggan capsule treatment group (75.96±3.91、46.28±2.63、29.68±3.46、1.59±0.25), antiviral treatment group (76.45±5.26、46.95±3.15、29.50±4.04、1.62±0.27),Diwuyanggan capsule combined with antiviral treatment group(75.13±4.04、46.39±2.34、28.74±2.92、1.63±0.18), groups, respectively, compared with before treatment, after statistics processing, the difference was not significant, P>0.05. After statistics processing,there was no significant difference among three groups,P>0.05.(3)The impact of the change of liver tissue pathology:after treatment,the histologic response rate of Diwuyanggan capsule treatment group was50.00%, the histologic response rate of the antiviral treatment group was22.22%,after statistics processing,there was no significant difference among three groups,P>0.05. Diwuyanggan capsule combined with antiviral treatment group histologic response rate was71.43%, compared with antiviral therapy group, after statistics processing,the difference was significant,P<0.05,but compared alone with Diwuyanggan capsule treatment group,the difference was not significant,P>0.05.(4)Safety evaluation, safety evaluation indicators (heart rate, blood pressure,weight, etc;the blood,urine and dung routine, electrocardiogram(ecg),kidney)were found no abnormal reactions associated with treatment,no obvious adverse events happen.Conelusion:Diwuyanggan capsule treatment alone or combined with antiviral for the treatment of HBeAg negative chronic hepatitis b was safe. The effect of Diwuyanggan capsule for the treatment of HBeAg negative chronic hepatitis B,the virological and biochemical responses, histological response were equal to antiviral treatment The curative effect of Diwuyanggan capsule combined with antiviral treatment of HBeAg negative chronic hepatitis B, the virological and biochemical responses were equal to Diwuyanggan capsule treatment or antiviral treatment alone, but the histological response was better than that of antiviral treatment alone. Separately the histologic response of Diwuyanggan capsule treatment group had the trend of superior to antiviral treatment group, it is necessary to further expand the sample for study.