[Entecavir combined with Fufang Biejia Ruangan tablet in treatment of chronic hepatitis B patients with liver fibrosis: 96-week efficacy analyses].
OBJECTIVE
To evaluate the effect of long-term therapy with entecavir and Fufang Biejia Ruangan tablet in patients with chronic hepatitis B (CHB)-associated fibrosis and explore the synergistic therapy that accelerates the reversion of liver fibrosis.


METHODS
A total of 197 patients with CHB-associated fibrosis were recruited from Nanfang Hospital between June, 2010 and June, 2015. The patients were divided into two groups after matching for age, gender and liver stiffness measurement (LSM), namely group A (n=98) treated with Fufang Biejia Ruangan Tablet plus entecavir, and group B (n=99) to receive entecavir only. HBV DNA quantification, HBV serological indicators, blood biochemical indexes, and results of abdominal ultrasound and FibroScan were recorded every 12 weeks. FibroScan values were converted to Metavir staging.


RESULTS
Both groups showed significant decreases in serum levels of HBV DNA, alanine aminotransferase (ALT), and LSM value from baseline (all P<0.05). The median time to achieve Metavir fibrosis staging improvement were 72 weeks in group A and 96 weeks in group B (P<0.05), and the median time to achieve ALT and AST normalization were 12 and 24 weeks in Group A, respectively, significantly shorter than the time in group B (P<0.05). No significant difference was found between the two groups in HBV DNA undetectable rate and HBeAg seroconversion rate.


CONCLUSIONS
The combination therapy with Fufang Biejia Ruangan tablet and entecavir produces a stronger efficacy than entecavir alone in the treatment of chronic hepatitis B patients with liver fibrosis, and Fufang Biejia Ruangan tablet shows an obvious hepatoprotective effect in these patients.
uangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China. E-mail: nianhuanyang@126.com.
Nian-Huan
NH
Yang
Guo-Sheng
GS
Yuan
Yu-Chen
YC
Zhou
Jun-Wei
JW
Liu
Hua-Ping
HP
Huang
Cheng-Guang
CG
Hu
Ling
L
Xiong
Yuan
Y
Li
Fu-Yuan
FY
Zhou
Shu-Ling
SL
Yang
Yuan-Ping
YP
Zhou
D000410:Alanine Transaminase / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy*; D013607:Tablets
D004279:DNA, Viral; D004365:Drugs, Chinese Herbal; D006513:Hepatitis B e Antigens; D013607:Tablets; C000599256:biejia ruangan; C413685:entecavir; D006147:Guanine; D000410:Alanine Transaminase