| ObjectiveTo observe the clinical effect and safeties of Hu gan pill on patienties of hepatic stagnation and splenic asthenia and deamp heat in liver and gallbladder with chronic hepatitis B. Meanwhile this research try to investigate the functional mechnism of Hu gan pill and provide scientific clinical basic for its product and use.Method48 patients diagnosed with HBV were all came from the Liver Disease Center of Hu Bei Hospital of TCM from the January 2007 to the January 2008. All cases'TCM syndroms were hepatic stagnation and splenic asthenia and deamp heat in liver and gallbladder. The cases were divided into 2 groups randomly ,24 cases were served as observed group and treated by "Hu gan pill",the other 24 cases were served as control group and treated by "Hu gan 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 syndrom integral,Hepatic function(ALT,AST,TBIL,A,G,GGT,AKP), liver spleen B supersonic wave change and safe index (blood urine routine and renal function ECG).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 syndrone therapeutic effect in clinic: after 3 months'treatment, comparing synthetic therapeutic effect in clinic, for the observed guoup ,the excellence rate was 41.7%, the total effective rate was 75.0%, for the control group, the excellence rate was 8.3 %, the total effective rate was 37.5 %, there were significant difference between 2 guoups(P < 0.05). Comparing TCM syndrone therapeutic effect, for the observed guoup, the recovery rate was 20.8 %, the total effective rate was 70.8 %, for the control group, the recovery rate was 8.3 %, the total effective rate was 29.2 %. There was significant difference between 2 groups(P < 0.05).3.TCM syndrome intergral change: after 3 months'treatment the intergral was obviously decreased in the 2 groups. Comparing with the control group, the intergral of the observedgroup was obviously decreased(P < 0.05). Comparing with the control group after the treatment surplus , the intergral of the observed group was obviously decreased(P< 0.01). 3 months after the follow-up visit the intergral was obviously drop out of the 2 groups. Comparing with the same group after 3 months'treatment, the intergral was decreased in the control group .the intergral was identical with 3 months after the treatment.4.The blood serum ALT change: 3 months after the treatment, comparing with the control group after the treatment, the value of ALT of the observed group was obviously decreased(P < 0.01); Comparing with the control group after the treatment surplus, the level of ALT of the observed group obviously droped out(P < 0.01). 3 months after the follow-up visit, Comparing with the same group after 3 months'treatment the value of ALT was decreased in the 2 groups(P < 0.01). 3 months after the follow-up visit, Comparing with the control group , the level of ALT of the observed group obviously droped out(P < 0.01).3 months after the treatment, the recovery rate was 66.7 % and 20.8 % respectly in the observed group and in the control group. 3 months after the follow-up visit, the recovery rate was 83.3 % 33.3 % respectly in the 2 groups. The recovery rate of the observed group obviously exceeded the control group(P < 0.01).5. The blood serum AST change: 3 months after the treatment, comparing with the control group after the treatment, the value of AST of the observed group was obviously decreased(P < 0.01). Comparing with the control group after the treatment surplus, the level of AST of the observed group obviously droped out(P < 0.01). 3 months after the follow-up visit, Comparing with the same group after 3 months'treatment, the value of AST was obviously decreased in the control group (P < 0.01),and it was identical with 3 months after the treatment in the observed group. 3 months after the follow-up visit, Comparing with the control group , the level of AST of the observed group obviously droped out(P < 0.01). 3 months after the treatment, the recovery rate was 58.3 % and 16.7% respectly in the observed group and in the control group. 3 months after the follow-up visit, the recovery rate was 75.5 % and 29.2 % respectly in the 2 groups. The recovery rate of the observed group obviously exceeded the control group(P < 0.01).6. The safety 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 Hu gan pill and Hu gan tablet could well improve symptom,physical sign of patients with HBV ,depress the level of ALT,AST, lighten the damage of liver, but the Hu gan pill obviously surpassed to Hu gan tablet. Comparing to the synthetic therapeutic effect and TCM syndrom therapeutic effect in clinical, the total effective rate of Hu gan pill was obviously better than Hu gan tablet.2.The clinical safety of Hu gan pill was better ,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. |
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