阿德福韦酯治疗拉米夫定耐药慢性乙型肝炎的临床疗效观察

Efficacy of adefovir dipivoxil in therapy for patients with chronic hepatitis B resistant to lamivudine

目的探讨阿德福韦酯治疗拉米夫定耐药慢性乙型肝炎的疗效及安全性。方法采用随机、双盲、拉米夫定对照的方法,选择76例拉米夫定耐药的慢性乙型肝炎患者作为研究对象,停用原来的拉米夫定,按1:1比例随机分为阿德福韦酯组38例和拉米夫定组38例,治疗疗程为48周。于治疗24周和48周时,观察2组HBVDNA水平、HBV血清学标志物及血清ALT变化,并记录不良反应。结果治疗24周和48周后服用阿德福韦酯组的患者血清HBVDNA应答率升高,ALT复常率持续上升,与拉米夫定对照组比较差异有统计学意义。血清HBeAg阴转率和血清转换率2组间差异无统计学意义。服用阿德福韦酯或拉米夫定24周及48周,2组均未发生与研究药物相关的严重不良反应。结论阿德福韦酯治疗拉米夫定耐药慢性乙型肝炎具有良好的疗效,且安全性好。

Objective To evaluate the efficacy and safety of adefovir dipivoxil in patients with hepatitis B resistant to lamivudine.Methods A randomized,double blind,lamivudine controlled study was conducted in 76 cases chronic hepatitis B patients resistant to lamivudine.Eligible patients stopped lamivudine therapy and were randomly assigned to receive adefovir dipivoxil（38 cases） and lamivudine（38 cases） for 48 weeks（ratio,1：1）.Serum HBV DNA,hepatitis B serology markers and ALT level were measured after therapy for 24 and 48 weeks,when the adverse events were recorded.Results After 24 and 48 weeks of treatment,HBV DNA levels and normalization of ALT levels in patients who received adefovir dipivoxil increased more than the patients in the other group.There was no significant statistical difference in HBeAg loss rate and HBeAg seroconversion rate between two groups.There was no severe adverse event related to the investigational product,adefovir dipivoxil and lamivudine,in this trial.Conclusion Adefovir dipivoxil was effective and safe for the treatment in lamivudine-resistant patients with chronic hepatitis B.