| ObjectiveHepatitis B virus(HBV)infection with strong infectivity is a global epidemic.It' s easy to become chronic hepatitis B(CHB),which has been a worldwide public health problem.HBeAg-positive CHB patients as a state of chronic HBV infection,the body of a large number of HBV replication will cause immune damage of liver cells,and then arise abnormal liver function,and even lead to end-stage liver diseases.The replication of HBV is a very important link in the development of disease.Therefore,inhibition of HBV replication is very important for the prevention and treatment of chronic HBV infection.Interferon is still used as one of the first-line drugs of antiviral therapy,especially the long-acting interferon(PegIFN-?),which has anti-viral and immune regulation dual role,but because of its many adverse reactions,clinical patients often not easy to adopt.However,it is aslo lack of large sample multi-center study for the syndrome and treatment of CHB patients in traditional Chinese medicine(TCM).So,this study focused on the treatment of the patients of HBeAg-positive CHB,using a Chinese herbal formula(invigorating the kidney and the spleen particles)combined with long-acting interferon,from the view of biochemistry,serology,virology and immunology,the author tested several indicators of efficacy and the symptoms and signs of TCM integral to make the effect observation on the treatment as well as to evaluate the clinical efficacy for the treatment of HBeAg-positive CHB patients,hoping to provide effective antiviral herbal compound that can improve the antiviral efficacy,which will rise to a new level on combining TCM and western medicine for the treatment of CHB patients,and provide new thinking and theoretical basis as well.MethodsIn this study,a randomized controlled experiment was conducted.Sixty patients with HBeAg-positive CHB were randomly assigned to treatment group and control group,and each group were 30 patients.The control group was treated with PegIFN-?-2a.The treatment group was treated with PegIFN-?-2a on the basis,and meanwhile to take a Chinese herbal formula(invigorating the kidney and the spleen particles)which consists of Epimedium,Eucommia ulmoides,Achyranthes bidentata,Achyranthes bidentata,Medlar,Phyllanthus emblica,Inula,Astragalus,Atractylodes,Poria,Citrus aurantium,Salvia miltiorrhiza.The course of treatment were 48 weeks.To test related efficacy and safety indicators in different stages of the treatment and observe liver function,hepatitis B serum markers,HBV-DNA,cytokines,the TCM symptoms and adverse reactions and so on before and after the treatment.The final data were dealt with by SPSS 22.0,and to evaluate the clinical efficacy with the statistical analysis results.Results1.The liver function(ALT,AST,TBil,ALB)of the two groups were both improved in the 48th week compared with before treatment(P all<0.05).Compare the two groups in 12th week,24th week,36th week and 48th week respectively,which showed that in 12th week and 24th week the comparations of all the indexes of liver function have no statistical significance(P all>0.05)while in 36th week and 48th week the comparations on the ALT and AST of two groups have statistical significance(Pall<0.05)and there are no statistical significance on TBil and ALB(P all>0.05).2.Compare the HBeAg negative-transmission of the two groups in 24th week showed that the comparation has no statistical significance(P>0.05).However,there are statistical significance in 48th week of the HBeAg negative-transmission(P<0.05)and seroconversion(P<0.05),and the efficiency of HBeAg negative-transmission and seroconversion of the treatment group were50.0%,33.3%respectively while the the control group were 23.3%?10.0%respectively.3.Compare the serum HBsAg levels of each groups which declined in some degree in 24th week and 48th week showed that the comparations have statistical significance(P all<0.01).After 48 weeks,the serum HBsAg levels of the treatment group were obviously lower than those before treatment.Besides,It has statistical significance when the treatment group compared with the control group at the same time(P<0.01).4.There is no significant difference in the levels of serum HBV-DNA between the two groups before treatment(P>0.05).Compare the serum HBV-DNA levels of each groups which declined in some degree in 24th week and 48th week showed that the comparations have statistical significance(P all<0.01).After treatment for 24 weeks,there are no significant difference of the two groups in the levels of serum HBV-DNA(P>0.05).Compare the serum HBV DNA levels of the two groups in 48th week showed that the comparation has statistical significance(P<0.01),and compare the rate of serum HBV DNA negative-transmission of the treatment group(26.7%)with the the control group(6.7%)showed that the comparation has statistical significance(P<0.05).5.After treatment for 24 weeks and 48 weeks,the levels of Thl-type cytokines IL-2 and IFN-y increased obviously in the two groups while Th2-type cytokines IL-4 and IL-10 declined substantially,which all have statistical significance(Pall<0.01).Compare the levels of Thl-type cytokines IL-2 of the two groups in 24th week showed that the comparation has statistical significance(P<0.01)while the comparations of the levels of Thl-type cytokines IFN-? and Th2-type cytokines IL-4 and IL-10 in two groups have no statistical significance(P all>0.05).Compare the levels of IL-2,IL-10,IL-4 and IFN-? of the two groups in 48th week showed that the comparations all have statistical significance(P all<0.01).6.The comparations of the TCM symptoms in the 24th week and 48th week showed that the treatment group(the total effective rates were 76.7%and 96.7%)were better than the control group(the total effective rates were 30%and 53.3%),and the comparations have statistical significance(P all<0.01).7.Compare with that before treatment,the white blood cells,neutrophils and platelets decreased substantially in 24th week and 48th week after treatment while the control group decreased more significantly,and the comparations have statistical significance(Pall<0.01).Compare the levels of the white blood cells and neutrophils of the two groups in 24th week and 48th week showed that the comparations have statistical significance(P all<0.05)while the levels of platelets have no statistical significance(P>0.05).Compare the flu-like symptoms of the treatment group(7 patients were present and the incidence was 23.3%)with the control group(18 patients were present and the incidence was 600%)in 48th week showed that the comparation has statistical significance(P<0.01).ConclusionsDuring the treatment of HBeAg-positive CHB patients,combining invigorating the kidney and the spleen particles of Chinese herba preparation with PegIFN-?-2a of antiviral drug has the advantages of displaying the predominance of TCM,enhancing the response rate(inciuding the biochemistry,serology,virology and immunology response)significantly of PegIFN-?-2a to HBV,improving the liver function,promoting serum HBeAg negative-transmission and seroconversion,declining the levels of serum HBsAg and HBV-DNA,inhibiting HBV-DNA replication effectively and promoting its negative-transmission,regulating the cytokines,improving uncomfortable symptoms caused by disease,relieving the adverse reactions caused by PegIFN-?-2a,which has significant meaning on the antivirus treatment and its prognosis. |
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