Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B
Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B
This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients
 with chronic hepatitis B in China. Half of participants will receive magnesium
 isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination,
 while the other half will receive a placebo and entecavir.
Chronic hepatitis B(HBV) has a high prevalence (>8%) in China. Entecavir, aguanosine analog,
 is a potent and selective inhibitor of HBV DNA polymerase.

 Glycyrrhizin has been used for more than 30 years in the treatment of liver diseases in Asian
 countries, who can relieve necro-inflammatory and liver fibrosis or cirrhosis Recent study
 has shown that inflammation plays the important role in chronic HBV and fibrosis or cirrhosis
 disease progression, but antiviral therapy only may not reduce inflammation ideally. The
 addition of glycyrrhizin to entecavir in the treatment may slow disease progression in
 patients with chronic HBV and advanced fibrosis or cirrhosis.
Inclusion Criteria:

 -  Hepatitis B surface antigen [HBsAg]-positive,

 -  Either hepatitis B e antigen (HBeAg)-positive or HBeAgnegative/hepatitis B e antibody
 (HBeAb)-positive disease were eligible,

 -  Serum alanine aminotransferase (ALT) levels 3-10×the upper limit of normal (ULN),serum
 total bilirubin(TBIL)levels<2×ULN

 Exclusion Criteria:

 -  Co-infection with hepatitis C virus, hepatitis D virus, or human immunodeficiency
 virus;

 -  Other forms of liver disease;

 -  More than 24 weeks of therapy with a nucleoside or nucleotide analog with activity
 against HBV, and therapy with any anti-HBV drug within 24 weeks prior to
 randomization;

 -  More than 12 weeks of therapy with liver protectants, and therapy with glycyrrhizin;

 -  Has decompensated liver function or has a hint of hepatocellular carcinoma (HCC);

 -  During the study patients were not allowed to use other medicines.