To observe the effect of Chinese medicine therapy for strengthening-Pi (脾) and nourishing-Shen (肾

SPNS) in preventing lamivudine induced YMDD mutation and its immunological mechanism. One hundred and sixty chronic hepatitis B (CHB) patients with positive HBeAg were equally assigned to two groups at random: the observation group and the control group. Patients in the observation group were treated with lamivudine combined with SPNS

and those in the control group were treated with lamivudine only

with the treatment lasting for 52 weeks in total. Changes in indexes

including liver function

HbeAg

HBV-DNA

YMDD variation

CD4

CD4/CD8 ratio

interferon-γ (IFN-γ)

interleukin-4 (IL-4)

blood routine

renal function

as well as any adverse reactions that occurred in patients

were observed at different time points. The ALT

AST recovery rate and HBV-DNA negatively inversing rate at the 24th week

the 36th week and the 52nd week were all higher (P<0.05); meanwhile

the YMDD mutation rate at the 36th week and the 52nd week was lower (P<0.05) in the observation group than in the control group. The posttreatment levels of CD4

CD4/CD8 ratio

IFN-γ

and IL-4 as well as the pre-post treatment difference of these indexes in the observation group were significantly different from those in the control group (P<0.05). Chinese medicine SPNS therapy can significantly reduce the YMDD variation of HBV

and the mechanism may be related to its regulation of the CD4 level

CD4/CD8 ratio and Th1/Th2 balance.