OBJECTIVETo evaluate the antiviral efficacy of Bushen Granule (BSG) combined with Marine Injection (MI) in treating patients with chronic hepatitis B of Gan-shen deficiency with Damp-Heat (GSD) syndrome type.

METHODSA total of 90 patients, who were HBV DNA, HBsAg, and HBeAg positive and of GS-DD type, were enrolled, and they were randomly assigned into 2 groups. The 49 patients in the treated group were treated with the combined therapy of BSG and MI and the 41 were administered with lamivudine, the therapeutic course for both groups was 1 year. The negative conversion rate of HBeAg and HBV DNA and the changes in HBV DNA titre, liver function, symptoms and physical signs were observed in the two groups before and after treatment.

RESULTSIn the treated group, the negative conversion rate of HBV DNA was 42.6% (20/ 47), insignificantly different to that in the control group (61.0%, 25/41, P > 0.05); the negative conversion rate of HBeAg and HBeAg/anti-HBe sero-conversion rate was 42.6% and 36.2%, respectively, significantly higher than those in the control group (22.0% and 17.0%, P < 0.05); the ALT normalizing rate was 74.4%, higher than that in the control group (51.4%, P < 0.05); the improvement of liver function (ALB and GLB) and clinical symptoms, especially the dizziness, soreness of waist, hypochondrial distending pain, and yellowish urine, were significantly superior to those in the control group(P < 0.01 or P < 0.05); and the partial response rate was 29.8%, insignificant different to that in the control group (14.6%, P > 0.05).

CONCLUSIONSCombined treatment of BSG and MI has an ideal short-term effect in treating patients with chronic hepatitis B of Gan-shen deficiency with Damp-Heat syndrome type, it can inhibit HBV replication and improve patients' liver function and physical signs.