Efficacy of a Chinese herbal formula on hepatitis B e antigen-positive chronic hepatitis B patients.

BACKGROUND: No guideline recommends antiviral therapy for hepatitis B e antigen (HBeAg)-positive chronic hepatitis B patients with persistently normal alanine aminotransferase levels and a high hepatitis B virus (HBV) DNA viral load. AIM: To evaluate the feasibility and safety of a Chinese herbal formula as a therapeutic option for chronic HBV infection. METHODS: In total, 395 patients (30-65 years old) with confirmed HBeAg-positive chronic hepatitis B infection and persistently normal alanine aminotransferase were randomized to receive either Chinese herbal formula or placebo for 96 wk. Endpoints to evaluate therapeutic efficacy included: (1) HBV DNA levels decreased to less than 4 log10 IU/mL at weeks 48 and 96; and (2) HBeAg clearance and seroconversion rates at weeks 48 and 96. RESULTS: HBV DNA levels ≤ 4 log10 IU/mL were 10.05% at week 48 and 18.59% at week 96 in the treatment group. The HBeAg clearance and conversion rates were 8.54% and 8.04% at week 48 and 16.08% and 14.57% at week 96, respectively. However, HBV DNA levels ≤ 4 log10 IU/mL were 2.55% and 2.55% at weeks 48 and 96, respectively, and the HBeAg clearance rates were 3.06% and 5.61% at weeks 48 and 96, respectively, in the control group. The quantitative hepatitis B surface antigen and HBeAg levels at baseline and changes during the treatment period as well as the alanine aminotransferase elevation at weeks 12 and 24 were strong predictors of HBeAg clearance. CONCLUSION: High rates of HBV DNA reduction, HBeAg clearance and seroconversion could be achieved with Chinese herbal formula treatments, and the treatments were relatively safe for HBeAg-positive chronic hepatitis B-infected patients with persistently normal alanine aminotransferase. The ability of the compound to modulate host immune function probably contributed to this effect.

[Relationship between HBV-DNA in peripheral blood mononuclear cells and syndrome types of TCM in chronic hepatitis B patients].

OBJECTIVE: To study the relationship between TCM syndrome type and HBV-DNA in serum and peripheral blood mononuclear cells (PBMCs) in chronic hepatitis B (CHB) patients. METHODS: The serum HBV markers,HBV-DNA levels in serum and PBMCs, were quantitatively detected in 220 CHB patients by PCR method, and TCM syndrome type of 205 patients were differentiated. RESULTS: Arranged from low to high, the percentages of CHB patients with the serum HBV-DNA > or = 1.0 x l0(5) copy/mL (high viral loading) in the five syndrome types were as follows: damp-heat retention in middle-jiao syndrome (DHRS, 55.2%), blood stasis blocking collateral syndrome (BSBC), Gan-Shen yin deficiency syndrome (GSYS), Pi-Shen yang deficiency syndrome (PSDS) and Gan stagnation with Pi deficiency syndrome (GSPS, 82.5%), the difference was significant between DHRS and GSPS; those with HBV-DNA in PBMCs infection were: GSYS (27.3%), DHRS (34.3%), BSBC (53.1%) and GSPS (77.2%). The percentage in GSPS was the highest, which was significantly different to that in other syndromes. CONCLUSION: Amount of serum HBV-DNA and PBMCs HBV-DNA infection has certain correlation with the TCM syndrome type of CHB. The highest percentage of patients with HBV-DNA > or = 1.0 x l0(5) copy/mL and PBMCs HBV-DNA infection presented in CHB patients of GSPS type. We should pay more attention to strengthen genuine qi to eliminate pathogenic factors in treatment of CHB.