阿德福韦酯治疗慢性乙型肝炎的临床研究

Clinical research on adefovir dipivoxil for the treatment of chronic hepatitis B

目的:观察阿德福韦酯(ADV)治疗HBeAg阳性慢性乙型肝炎的疗效及其安全性。方法:0～12周:实验组给予口服阿德福韦酯胶囊,10mg/d,对照组给予口服安慰剂。13周～48周:两组均口服阿德福韦酯胶囊。治疗后定期检查乙型肝炎病毒血清学标志物、HBVDNA水平以及其他不良反应。结果:治疗12周时,试验组HBVDNA下降水平和阴转率高于对照组。12周、24周时,试验组HBeAg阴转率、ALT复常率均显著高于对照组。48周时,两组HBVDNA、HBeAg阴转率及ALT复常率均无显著差异。结论:ADV安全性好,可有效抑制HBVDNA复制。

Objective： To evaluate the efficacy and safety of adefovir dipivoxil （ADV） for the treatment of hepatitis Be antigen positive chronic hepatitis B.Methods：During the first 12 weeks, experiment group were treated with ADV （10mg/d）, and control group were treated with placebo.During the second periods （13th week to 48th week）, all patients were treated with ADV. The serum level of HBV DNA and HBV marker and other adverse reaction were detected.Results：At week 12, reduced level of HBV DNA and the rate of under detection in experiment group were higher than control group. The rate of HBeAg loss and ALT normalization at week 12 and week 24 were also higher in experiment group. At week 48, the rate of HBV DNA under detection, HBeAg loss and ALT normalization had no difference. The incidence of adverse reaction were similar in the two groups.Conchlsion：ADV can inhibit HBV DNA replication effectively and safely.