两种阿德福韦酯片治疗慢性乙型肝炎96周的疗效和安全性比较

Comparisons of efficacy and safety between two kinds of adefovir dipivoxil(Daiding and Hepsera) on treament of chronic hepatitis B

目的观察比较两种阿德福韦酯片(代丁和贺维力)治疗慢性乙型肝炎患者的疗效和安全性。方法收集随访门诊的慢性乙型肝炎患者122例,根据所选用药物不同分为代丁组66例(选用代丁抗病毒治疗)和贺维力组56例(选用贺维力抗病毒治疗),两组的人口学特征、肝功能、HBV DNA定量及HBeAg阳性率等基线资料相当;分别在24、48、96周观察两组患者的肝功能、HBV DNA下降幅度、HBV DNA不可检出率、病毒学标志物变化及不良反应等指标。结果随着抗病毒时间延长,两组的ALT复常率、HBV DNA下降幅度及不可检出率、HBeAg转阴率均有增加,但在24、48、96周时两组比较差异无统计学意义(P>0.05)。随访96周,代丁组累积病毒学突破率为13.6%,贺维力组为16.1%,两组差异无统计学意义(P>0.05)。两组均无患者因药物不良反应而停药。结论代丁与贺维力均能有效改善肝功能,抑制HBV DNA及有较好的安全性,96周内无明显差异。

Objective To compare the efficacy and safety between two kinds of adefovir dipivoxil（Dai ding and Hepsera） on treatment of chronic hepatitis B（CHB）.Methods A total of 122 patients in clinic with CHB were enrolled and divided into Daiding group（n=66） and Hepsera group（n=56）,in which the age,gender,serum alanine aminotransferase（ALT）,HBV DNA and HBeAg status were matched.Serum ALT level,HBV DNA drop,HBeAg clearance,rates of undetected HBV DNA and drug adverse reactions were analyzed at the time of 24,48 and 96 weeks.Results The rates of ALT normalization,HBV DNA drop,HBeAg clearance and undetected DNA were increased along with antiviral therapy prolonged in both groups,with no significant difference between them（P0.05）.At the 96th week,the cumulative rates of viral breakthrough were 13.6%（9/66） and 16.1%（9/56） in Daiding group and Hepsera group,respectively,with no significant difference revealed（P0.05）.No adverse event was reported.Conclusion Two kinds of adefovir dipivoxil（Daiding and Hepsera） are effective in improving liver function and suppressing HBV replication,with good safety for patients with CHB.There are no significant difference in the efficacy and safety in 96-week follow-up.