A Clinical Study Of Periplaneta Americana Extract For The Treatment Of HBeAg Positive Chronic Hepatitis B

Objective:1.To evaluate the efficacy and safety of Periplaneta Americana Extract for treating HBeAg positive Chronic Hepatitis B,and to observe the mechanisms of its immune regulation.2.To compare efficacy of the two preparations of Ganlong Capsule.Methods:A randomized,double-blind trial was performed for 24 weeks.Thirty patients,who were diagnosed as HBeAg positive chronic hepatitis B in the Infectious Diseases Branch,the First Affiliated Hospital of Kunming Medical College and need anti-viral therapy immediately,were selected and Ganlong Capsule was administered orally in a dose of 0.6g,twice a day.Among the 30 patients,half of them were assigned to Ganlong group A randomly,while the others were distributed to Ganlong group B.15 cases of HBeAg positive chronic HBV carriers and 15 healthy individuals were collected as two control groups.The effects of Ganlong Capsule on the CD3⁺T cells,CD4⁺T cells,CD8⁺T cells,T helper cells 1(Th1 cells),T helper cells 2,the level of serum hepatitis B virus(HBV) deoxyribonucleic acid(DNA),alanine aminotransferase(ALT) and serological indicators including e antigen/e antibody seroconversion,were observed in the 4^th week,12^th week,24^th week during the treatment.The adverse reactions to the drug were monitored.Results:So far,the 24 weeks of treatment were accomplished by 24 patients,among whom 12 cases were in Ganlong group A and 12 cases were in group B.The outcomes showed that:1.The proportion of Th1 cells at the 4^th week was significantly higher than that before treatment(P＜0.05).The ratio of CD4⁺/CD8⁺ T cells at the 12^th week was significantly higher than that before treatment(P＜0.01),while the proportion of CD8⁺ T cells was significantly lower(P＜0.01).Between the 12^th week and the 24^th week,the proportion of CD4⁺ T cells(P＜0.05) and the ratio of CD4⁺/CD8⁺ T cells(P＜0.01) decreased notably.It indicated that the proportion of CD3⁺ T cells declined obviously at the end of 24 weeks' treatment(P＜0.01).2.At the end of the 24 weeks' treatment,ALT and HBV-DNA levels declined significantly(P＜0.05) in Ganlong group A,while there seems to be no significant difference between before and after treatment in Ganlong group B.The HBeAg loss rate of both Ganlong group A and B was 25%,and the HBeAg seroconversion rates of the two groups were 16.7%and 25%.ALT normalization rate of both Ganlong group A and B was 16.67%.3.The adverse reactions were slight,only nausea and weak in 4 individuals just at the beginning of the treatment,without fever,rash,vomiting,jaundice,diarrhea,muscle aches,glucose abnormality,renal dysfunction or failure,hepatic encephalopathy,et al.Conclusion:1.Periplaneta Americana extract(PAE),which has up-regulated the proportion of Th1 cells and the ratio of CD4⁺/CD8⁺ T cells significantly,has immune regulation effects.2.PAE exceeds nucleoside analogues in the aspects of HBeAg clearance and seroconversion.It can reduce the HBV-DNA level,and it is an effective,convenient and safe medication for treating HBeAg positive chronic hepatitis B.3.The efficacy of preparation A exceeds that of preparation B in the aspect of reducing ALT and HBV-DNA.According to the HBeAg clearance and e antigen/e antibody seroconversion rate,there was no significant difference between the two preparations of Ganlong Capsule.