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

Table 2 Inclusion and exclusion criteria of patients

Inclusion criteria	Exclusion criteria
Conform with the diagnostic criteria of HBeAg (+) chronic hepatitis B	Inactive HBsAg (+) carriers
Conform with the pathogenesis and syndromes of kidney deficiency	Serum a-fetoprotein abnormal
Age 30-65 yr	Pregnancy or breast feeding
ALT ≤ 40 IU/L	Coinfection with HIV, HCV, HDV
HBsAg > 10 IU/mL and < 105 IU/mL HBV DNA (105-109 IU/mL)	Histologic evidence of cirrhosis; Evidence of any other chronic liver disease
Liver biopsy: Liver histology showed Knodell HAI > 4, Ishak fibrosis score > 3 were also included	Mental illness or any other serious systemic illness
Voluntary	Interferon-γ within 6 mo; Antivirus treatment with nucleoside
	Abuse alcohol or illegal drugs; Allergic to the drug ingredients

HBeAg: Hepatitis B e antigen; HBsAg: Hepatitis B surface antigen; ALT: Alanine aminotransferase; HBV: Hepatitis B virus; HIV: Human immunodeficiency virus; HCV: Hepatitis C virus; HDV: Hepatitis D virus; HAI: Histological activity index.