A randomized, multi-central, controlled study of patients with hepatitis B
e antigen-positive chronic hepatitis B treated by adefovir dipivoxil or
adefovir dipivoxil plus bicyclol
Xie W et al. – Adefovir dipivoxil plus bicyclol combination therapy is a
safe and superior treatment regimen for patients with HbeAg-positive
chronic hepatitis B(CHB) when compared with adefovir dipivoxil(ADV)
monotherapy.
Methods• Total of 250 patients with HBeAg-positive CHB were randomized to
ADV plus bicyclol combination group and ADV monotherapy group.
• Patients in the ADV plus bicyclol combination therapy group (n=125)
received ADV 10 mg orally q.d. and bicyclol 25 mg orally t.i.d. for 48
weeks, and those in the ADV monotherapy group (n=125) were administered ADV
10 mg orally q.d. alone for 48 weeks.
• Serum aminotransferases (ALT/AST), HBV DNA, HBeAg/HBeAb, and liver
biopsy were conducted before and after therapy.
Results• Serum aminotransferase levels were decreased significantly in
both groups.
• Serum aminotransferase level in ADV plus bicyclol combination therapy
group decreased greater than that in ADV monotherapy group (P< 0.01).
• Virological response rate in ADV plus bicyclol combination therapy
group was not significantly different from that in ADV monotherapy group
(P> 0.05).
• After treatment for 48 weeks, the Knodell necroinflammatory score of
the two groups were all alleviated significantly, and the Knodell score in
the combination group was significantly lower than that in the ADV
monotherapy group (P< 0.05).
• There were no remarkable adverse events probably related to the drug in
this study.作者: StephenW 时间: 2011-8-3 07:55