ObjectiveTo observe the clinical effect and safeties of Jin suan ping particle on patienties of deamp heat in liver and gallbladder with chronic hepatitis B.Meanwhile this research try to investigate the functional mechnism of Jin suan ping particle and provide scientific clinical basic for its product and use.Method42 patients diagnosed with HBV were all came from the Liver Disease Center of Hu Bei Hospital of TCM from the hugust 2007 to the December 2008.hll cases' TCM syndroms were hepatic stagnation and splenic asthenia and deamp heat in liver and gallbladder.The cases were divided into 2 groups randomly,21 cases were served as observed group and treated by "Jin suan ping",the other21 cases were served as control group and treated by "Li gan long particle".both of the groups were 3 months for the course of treatment,3 months for the treatment follow-up visit.Observing the TCM syndrom integral,Hepatic function(ALT,AST,TBIL,A), liver spleen B supersonic wave change and safe index(blood urine routine and renal function ECG).Results1.The cases selected:There were 42 patients(21 of the observed group,21 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.TCM syndrone therapeutic effect in clinic:Comparing TCM syndrone therapeutic effect,for the observed guoup,the recovery rate was 23.8%,the total effective rate was 81.0%,for the control group,the recovery rate was 4.8%,the total effective rate was 52.4%.There was significant difference between 2 groups(P < 0.05).3.Various TCM syndrome intergral change:Comparing two cases before treatment of various syndromes by t-test,there is no significant differences and is comparable(P>0.05).After 3 months treatment,two cases of main TCM syndrome are reduced.Compared with the control group,the main symptoms such as yellow body and eyes,dry mouth and bitter,full belly bulge,NaCha,heavy fatigue and yellow urine in treatment group is significant difference by t-test(P < 0.05).Aphis rib sting or pain,constipation,loose stools and itchy skin is no significant difference by t-test(P>0.05).4.TCM symptom intergral change:After 3months'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<0.05).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 5.The blood serum hLT.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 < 0.05); Comparing with the control group after the treatment surplus,the level of ALT of the observed group obviously droped out(P < 0.05). 3 months after the follow-up visit,Comparing with the same group after 3 months' treatment the value of ALTwas 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).6.The blood serum hST change:3 months after the treatment, comparing with the control group after the treatment,the value of hST of the observed group was obviously decreased(P < 0.05). Comparing with the control group after the treatment surplus, treatment group and control group in AST level follow-up of 3 monthly decreased obviously(P < 0.01).3 months after the follow-up visit,comparing with the same group after 3months' 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.3months after the follow-up visit,comparing with the control group,the level of AST of the observed group obviously droped out(P< 0.01).7.Normalization of liver function rate:3 months after the treatment,the recovery rate was 71.43%and38.10%respectly in the observed group and in the control group.3 months after the follow-up visit,the recovery rate was 66.67%and33.3%respectly in the 2 groups.The recovery rate of the observed group obviously exceeded the control group(P<0.05).Comparative efficacy of two Tuihuang,3 months after the treatment,the recovery rate was80.00 %and38.46%respectly in the.observed group and in the control group(P < 0.05).8.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 Jin suan ping particle and Li gan long particle could well improve symptom,physical sign of patients with HBV,depress the level of hLT,AST,lighten the damage of liver,but the Jin suan ping particle obviously surpassed to Li gan long particlet. Comparing to the synthetic therapeutic effect and TOM syndrom therapeutic effect in clinical,the total effective rate of Jin suan ping particle was obviously better than Li gan long particle.2.The clinical safety of Jin suan ping particle 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. |