Clinical Effect Observation Of Ganlei Granule Combine With Western Medicine In Treating Syndrome Of Hepatic Stagnation And Spleen Deficiency Type Chronic Hepatitis B

Purpose: To observe the effect which includes the effect of Ganle granules on clinical symptoms and laboratory indexes of Ganle granules combined with entecavir in the clinical treatment of syndrom of hepatic stagnation and spleen deficiency type chronic hepatitis B.And to evaluate the safety and efficacy of Ganle granules,to explore the possible mechanism of Ganle granules in the treatment of chronic hepatitis B,to provide a new treatment strategy for the treatment of chronic hepatitis B with the combination of traditional Chinese medicine and western medicine,so as to provide more choice and scientific basis for the future clinical treatment of chronic hepatitis B.Method:Sixty patients of chronic hepatitis B liver with depression and Spleen deficiency were randomly divided into control group and treatment group.The treatment group was treated with entecavir and Ganle granules.The control group was treated with entecavir.The levels of TCM symptoms,liver function(ALT,AST,GGT,AKP,TBIL,ALB),HBs Ag,HBV DNA,four results of liver fiber(HA,LN,P ?NP,C?)and safety indexes were observed before and after treatment for 24 weeks and 48 weeks to evaluate the immediate effect of Ganle granules in the treatment of chronic hepatitis B.Result:1.Tow groups after treatment can significantly improve the overall TCM syndrome.(P<0.01).The effect after treatment 48 weeks was significantly better than 24weeks(P<0.01).The patients of treatment group were significantly better than those in the control group after treatment(P<0.05).2.After treatment of 24 weeks and 48 weeks in the treatment group,all symptoms were better than that before treatment(P<0.05).The improvement of chest pain,anorexia,epigastric fullness,tastelessness,loose stool,belching,breast pain after treatment 48 weeks is better than that after treatment 24 weeks(P<0.05).It is no statistically significant difference in the sigh,fatigue,tongue and pulse(P>0.05).3.In addition to breast pain(P>0.05),the other symptoms((P<0.05))have improved better than that before treatment in the control group.All symptoms improved after treatment48 weeks are better than that before treatment(P<0.05).The improvement of all symptoms(P<0.05)except tongue and pulse(P>0.05)after treatment 48 weeks are better than that after treatment 24 weeks.4.Two groups are compared after 24 weeks of treatment,the improvement of sign,epigastric,fullness,fatigue,tastelessness,loose stools in treatment group is better than that in control group(P<0.05).It is no statistically significant difference in the chest pain,anorexia,belching,breast pain,tongue and pulse(P>0.05)5.The total effective rate of the treatment group is significantly better than that of the control group after treatment 24 weeks and 48 weeks(P<0.01).6.In the treatment group,both treatment 24 weeks or 48 weeks,the improvement of each laboratory index is significantly better than that before treatment(P<0.01).The improvement of ALB,HBs Ag and four results of liver fiber after treatment 48 weeks are significantly better than that after treatment 24 weeks(P<0.01).7.In the control group,both treatment 24 weeks or 48 weeks,the improvement of each laboratory index is significantly better than that before treatment(P<0.01).The improvement of HBs Ag and four results of liver fiber after treatment 48 weeks are better than that after treatment 24 weeks(P<0.05).8.Two groups are compared after 24 weeks of treatment,the improvement of four results of liver fiber in treatment group is better than that in control group(P<0.05).Two groups are compared after 48 weeks of treatment,the improvement of four results of liver fiber and TBIL in treatment group is better than that in control group(P<0.05).9.The safty indexes of two froups fluctuates within the range of medical reference vlue.It is no significance befosre and after treatment.Conclusion:1.Ganle granules are effective for the patients of chronic hepatitis B with syndrom of hepatic stagnation and spleen deficiency on the basis of antivirotic treatment anf Ganle granules can effectively improve the clinical symptoms and TCM syndrome.2.Ganle granules can reduce the index of TBIL and four results of liver fiber.However,the specific mechanism of Ganle granules need to be further explored.3.There is no obvious adverse reaction in the clinical application of Ganle granules.