Objective: To observe the effect of Wenshen prescription on toll-like receptor 4 (TLR4)/interleukin-6 (IL-6) signaling pathway in chronic hepatitis B(HBV) patients with high ALT level and kidney Yang deficiency syndrome. Method: A total of 68 CHB patients with high ALT level treated in our hospital from July 2013 to May 2014 were selected as research objectives

with 34 cases in each group. Eligible patients were given Wenshen prescription combined with telbivudine (treatment group) or placebo combined with telbivudine (control group) for 24 weeks. Peripheral blood hepatitis B virus DNA

HBV markers

IL-6 were measured at week 0

12 and 24.The mRNA expression of TLR4 in peripheral blood mononuclear cell (PBMC) was measured by Real-time PCR

and helper T cells (Th17)/regulatory T cells (Treg) ratio was measured by flow cytometry. Result: There was no significant difference at baseline between the two groups. With the increase of treatment time

HBV DNA negative conversion rate

HBeAg negative conversion rate and seroconversion rate of the two groups were gradually decreased. At week 24

treatment group was superior to control group in the rates of HBV DNA negative conversion

HBeAg negative conversion and seroconversion. During the treatment

the peripheral blood IL-6

TLR4 mRNA levels and Th17/Treg ratio first increased and later decreased in the treatment group. They reached the peak at week 12

which were significantly higher than the baseline (P<0.05). At week 12 and 24

the peripheral blood IL-6

TLR4 mRNA and Th17/Treg in treatment group were superior to those in control group (P<0.05). Conclusion: Wenshen prescription has an increased antiviral effect on telbivudine-treated CHB patients with high ALT level and kidney Yang deficiency syndrome

and its mechanism may be related to the regulation of Th17/Treg balance by TLR4/IL-6/STAT3 signaling pathway.