A randomized,double-blind,multicenter study of adefovir dipivoxii in treating patients with HBeAg-positive chronic hepatitis B
- VernacularTitle:国产阿德福韦酯片治疗HBeAg阳性慢性乙型肝炎的双盲、随机、多中心临床研究
- Author:
Hong ZHAO
;
Chong-Wen SI
;
Yue-Xin ZHANG
;
Xin-Yue CHEN
;
Lei WANG
;
Xiao-Ping TANG
;
Chunliang LEI
;
- Publication Type:Journal Article
- Keywords:
Adefovir dipivoxil;
Hepatitis B,chronic;
Hepatitis B e antigens;
Multicenter studies
- From:
Chinese Journal of Infectious Diseases
2000;0(02):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of adefovir dipivoxil(ADV)in treating patients with hepatitis B e antigen(HBeAg)positive chronic hepatitis B.Methods In this randomized,double blind,placebo-controlled,multicenter trial,210 eligible patients with HBeAg positive chronic hepatitis B were recruited and randomized(randomization ratio was 2:1)receiving ADV 10 mg/d for 48 weeks(ADV+ADV group,n=142)or placebo for 24 weeks followed by ADV 10 mg/d for 24 weeks(PLB+ADV group,n=68).The primary endpoint was virological response. The secondary endpoint was serologic response(HBeAg loss rate and HBeAg seroconversion rate) and alanine aminotransferase normalization rate.Results After 24 weeks therapy,mean reduction of hepatitis B virus(HBV)DNA level comparing with that of baseline was 3.12 log_(10)copy/mL in ADV +ADV group while it was 0.95 log_(10)copy/mL in PLB+ADV group.The percentages of patients with HBV DNA clearance(HBV DNA level
