OBJECTIVETo investigate the clinical effect of combination therapy with Fufang Biejia Ruangan tablet and entecavir in patients with hepatitis B virus (HBV)-related cirrhosis.

METHODSA total of 163 patients with HBV-related cirrhosis were recruited for treatment between March 2010 and August 2012, and divided into the following three groups:group A (n =56) received Fufang Biejia Ruangan Tablet plus entecavir; group B (n =52) received entecavir only; and group C (n =55) received Fufang Biejia Ruangan tablet only. Enzyme-linked immunoassay methods were used to measure serum levels of hyaluronic acid (HA), laminin (LN), collagen (PCIV) and prolyl endopeptidase (PLD). The grade of liver fibrosis was determined upon liver biopsy, and score of liver stiffness was measured by FibroScan.

RESULTSAll three treatment groups showed significant decreases from baseline in serum levels of alanine aminotransferase, aspartate aminotransferase, HBV DNA, HA, LN, PCIV and PLD (all P < 0.05). However, the changes in HA, LN, PCIV and PLD levels were significantly greater in group A than in either group B or C (P < 0.05). All three treatment groups showed significant improvements from baseline in liver fibrosis grade and liver stiffness score (P < 0.05). The total effective rate of group A was 82.14%, which was significantly higher than that of groups B and C (P < 0.05).

CONCLUSIONCombination therapy of Fufang Biejia Ruangan tablet plus entecavir is effective for treating HBV-related cirrhosis.