Objective: To discuss the clinical efficacy of Qingying Huoxue decoction in treating primary biliary cirrhosis (PBC) with liver-gallbladder dampness-heat syndrome

and investigate its effect on Th17/Treg levels in serum. Method: Ninety-eight PBC patients with liver-gallbladder dampness-heat syndrome were randomly divided into control group (49 cases) and treatment group (49 cases) by digital table method. The patients of control group received compound glycyrrhizin tablets by oral administration for two weeks (2 tablets/time

tid) and then ursodeoxycholic acid capsules were taken by oral administration after meals

13-15 mg·kg-1·d-1

tid. The patients of treatment group received Qingying Huoxue decoction based on the treatment of control group (1 dose/d

bid). The treatment course was 24 weeks for both groups. The traditional Chinese medicine(TCM) clinical symptom scores were compared between two groups;the clinical efficacy of two groups after 24 weeks of treatment were analyzed. Helper T lymphocytes (Th17) and regulatory T cells (Treg) in peripheral blood were compared between two groups. The levels of interleukin(IL)-17

IL-6 and transforming growth factor-β(TGF-β) in the serum were detected in two groups. Result: The TCM clinical symptom scores in treatment group were significantly lower than those in control group after treatment (P < 0.01). The total response rate was 93.88% in treatment group

significantly higher than 77.55% in the control group (P < 0.05). Th17 level in peripheral blood of treatment group was significantly lower than that of control group after treatment

while Treg level was significantly higher than that of control group after treatment (P < 0.01). The levels of IL-17 and IL-6 in serum of treatment group were significantly lower than those of control group

while TGF-β level was significantly higher than that of control group after treatment

with statistically significant differences (P < 0.01). Conclusion: Based on the western medicine

Qingying Huoxue decoction could significantly improve clinical symptoms and clinical efficacy in the treatment of PBC with liver-gallbladder dampness-heat syndrome

and its mechanism may be related to regulating Th17/Treg balance in peripheral blood and its cytokine levels.