阿德福韦酯治疗YMDD变异慢性乙型肝炎82例

目的:研究阿德福韦酯治疗YMDD突变后慢性乙型肝炎患者的疗效和安全性。方法:82例YMDD突变的慢性乙型肝炎患者分为对照组和试验组,对照组服用拉米夫定100mg·d-1,48周,试验组服用阿德福韦酯10mg·d-1,48周。服药后第24,48周检测谷丙转氨酶(ALT)、HBV DNA定量、HBeAg及观察不良反应。结果:试验组24及48周HBV DNA下降水平均明显高于对照组(均P<0·01),HBV DNA应答率和ALT复常率也均高于对照组(均P<0·01),HBeAg阴转率两组无显著性统计学差异。两组均未发现明显不良反应。结论:阿德福韦酯治疗YMDD突变的慢性乙型肝炎安全有效。

Clinical trial of adefovir dipivoxil for chronic hepatitis B patients with YMDD mutation

Objective:To observe the efficacy and safety of adefovir dipivoxil(ADV)for chronic hepatitis B(CHB)with YMDD mutation during lamivudine(LAM)therapy.Methods:82 cases of CHB patients with YMDD mutation were allocated in an ADV group(10 mg daily)and a LAM group(100 mg daily).After 24 and 48 weeks of treatment,serum HBV DNA levels,liver function and HBV serology were measured,and safety assessments were also conducted.Results:The mean reduction of HBV DNA at 24 and 48 weeks was significantly greater in the ADV group compared with that in the LAM group(P<0.01).In the ADV group,the HBV DNA response and ALT normalization at 24 and 48 weeks were significantly higher than those in the LAM group(P<0.01).There was no significant difference between the two groups in the portion of HBeAg reduction.There was no severe adverse event related to the investigational product.Conclusion:ADV is an effective and safe medication for treating CHB with YMDD mutation during LAM therapy.