Jian Gan Granule Treatment Of Qi-Yin Deficiency And Blood Stasis With Chronic Hepatitis B Clinical Research

Objective:To observe the effect of Jian gan Granule on Patients of Qi - Yin deficiency and blood stasis with chronic hepatitis B.Meanwhile this research try to investigate the functional mechanism of Jian gan Granule and provide scientific clinical basic for its product and use.Methods:Choose the patients of Qi - Yin deficiency and blood stasis with chronic hepatitis B as observing objects.Seventy-four cases were randomly divided into 2 groups,each 37,one for treatment and the other for control,observed by double blind method.For treatment group,treated by Jian gan Granule,otherwise in control group,Yigan Yangyin Huoxue Granule 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,Tbi1,DbiL,AKP,GGT,ALB and PT),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.Results:1.Comparison of the overall effect:markedly effective for the treatment group,28 cases(75.67%), effective in 5 cases(13.53%),ineffective four cases (10.8%),markedly effective rate 75.67%,the total effective rate 89.2%;control group,markedly effective in 23 cases(63.89%),effective in 6 cases (19.41%),ineffective in 5 cases(16.7%),markedly effective rate 63.89%,total effective rate of 83.3%, efficacy of the treatment group than the control group, but both showed no significant difference(P＞0.05).2.Comparison of decline in liver function effect:(1) The range of ALT' s dropping had statisticd difference between two groups(P＜0.05),treatment group made more remarkable curative effects.The range of AST' s dropping hadn' t statistics difference between two groups(P＞0.05)The total effective rates were 86.49% and 72.22%in treatment and control group.It was an obvious difference between two groups(P＜0.05). (2) The treatment group had obviously improve function on AKP,GGT,A,G,TBIL,DBIL,PT.The control group didn' t do it on A,TBIL,however.But it wasn' t an obvious difference two groups(P＞0.05 ).3.The curative effect of traditional Chinese medicine syndrome:The treated groups:obvious effective rate is 81.08%,total progressive rate is 94.59%;The controlled group:obvious effective rate is 77.78%,total effective rate is 91.66%.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 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:Jian gan Granule can well improve symptom and physical sign of the patients of Qi - Yin deficiency and blood stasis syndrome with chronic hepatitis B,and reduce enzyme(especially ALT),Jian gan Granule have assuaring liver,falling enzyming.In reducing enzyme (especially ALT) and improvement of symptoms (especially coerce not aching,dry mouth) is better than yigan Yangyin Huoxue Granule.It have not the serious side effects in this clinical research.Jian gan Granule is the effectual and secure medication to Qi - Yin deficiency and blood stasis syndrome with chronic hepatitis B from the research.