阿德福韦酯治疗YMDD变异慢性乙型肝炎82例

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

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。

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.