Clinical Study On HBeAg Serological Transformation Of Patients With Chronic Hepatitis B Promoted By Yiqi Fuzheng

Objective:To evaluate the immunomodulatory effect of Yiqi Fuzheng Fang and its response to HBeAg serum by studying the changes of lymphocyte subsets,HBeAg Yin conversion rate,HBeAg/anti-HBe serological conversion rate,HBV-DNA Yin conversion rate,liver function recurrence rate,TCM symptom and sign score after treatment with Yiqi Fuzheng Fang with HBeAg positive chronic hepatitis B.In order to improve the prognosis and outcome of chronic hepatitis B,provide therapeutic ideas and empirical evidence.Methods:Patients who met the criteria of diagnosis and inclusion were randomly divided into treatment group and control group 33 cases each,both groups were given compound glycyrrhizin tablets,silibinin capsule anti-inflammatory liver protection basic treatment.The control group was given entecavir tablets,and the treatment group was given Yiqi Fuzheng Fang combined with entecavir tablets.the peripheral blood T lymphocyte subsets（CD₄⁺、CD₈⁺、CD₄⁺/CD₈⁺values）,HBeAg、anti-HBe、HBV-DNA quantification,liver function（ALT、AST）and TCM symptom scores were observed and recorded in the two groups before,at 12 and 24 weeks of treatment.Result:（1）Total effective rate:93.75%in the treatment group and 78.12%in the control group.The difference of total effective rate between the two groups was statistically significant（P<0.05）,suggesting that for patients with HBeAg positive chronic hepatitis B,the overall effect of Yiqi Fuzheng Fang combined with entecavir tablets was better than that of entecavir tablets alone.（2）Comparison of curative effect of TCM syndromes:the total effective rate of the treatment group and the control group was96.88%and 81.25%,respectively.The difference between the two groups before and after treatment was statistically significant（P<0.05）,indicating that both groups of drugs could improve or disappear the clinical symptoms of the patients,and the effect of the treatment group was better than that of the control group.（3）Liver function biochemical response（ALT、AST）:after 12 w、24w of treatment,the two groups had significant statistical significance compared with before treatment（P<0.01）,and the difference between the two groups was not statistically significant（P>0.05）,indicating that both groups of drugs could significantly improve the liver function enzymatic index,but the curative effect advantage of the treatment group was not obvious.（4）HBV-DNA virological response rate:after 24w of treatment,the of the treatment group and the control group were 84.38%and 81.25%,respectively.there was no significant difference between the two groups（P>0.05）,suggesting that both groups could effectively promote the HBV-DNA conversion,but there was no significant difference in curative effect.（5）HBeAg serological responses:There was no significant difference HBeAg serological response levels between the two groups after 12 w of treatment（P>0.05）.After 24 w of treatment,the serological conversion rates of HBeAg yin,yang and serology were 59.38%,31.25%and 31.25%in the treatment group and 31.25%in the control group.The results showed that the effect of treatment group on improving HBeAg serological response level was not obvious compared with that of control group at 12 w,but the effect of treatment group was better than that of control group at 24 w.（6）Cellular immune index:peripheral blood T lymphocyte subsets:After12w and 24w treatment,the CD₄⁺,CD₈⁺,CD₄⁺/CD₈⁺values were compared within the group.The CD₄⁺value of the treatment group improved significantly（P<0.01）,and the CD₄⁺/CD₈⁺value did not improve significantly at 12w,but improved significantly after24w,CD₈⁺value No statistical significance（P>0.05）,indicating that the treatment group can improve CD₄⁺,CD₄⁺/CD₈⁺,but not yet improve CD₈⁺;the control group has statistical significance at 24w,combined with the change trend chart before and after treatment in both groups,it is found that the control group CD₄⁺The value increased,the CD₈⁺value decreased,the CD₄⁺/CD₈⁺value increased,and the patient’s immune function tended to be low,indicating that the treatment group could significantly improve the immune status and improve the cellular immune function.（7）No adverse reactions occurred during the trial and after treatment.Conclusion:Yiqi Fuzheng Fang combined with entecavir tablet in the treatment of HBeAg positive chronic hepatitis B,in improving clinical symptoms,liver function,HBV-DNA、HBeAg serological response level and cellular immune function,especially can significantly improve the HBeAg serological response level of patients,its mechanism may be related to the improvement of cellular immunity function（T lymphocyte subsets CD₄⁺、CD₄⁺/CD₈⁺values）,Yiqi Fuzheng has a positive effect on the prognosis and outcome of chronic hepatitis B,the overall clinical efficacy is good and safe.