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目的探讨阿德福韦酯治疗拉米夫定耐药乙型肝炎e抗原(HBeAg)(+)慢性乙型肝炎患者的疗效及安全性。方法采用多中心、随机、双盲双模拟的临床试验,选择拉米夫定耐药的HBeAg(+)的慢性乙型肝炎患者106例作为研究对象,按1∶1的比例随机分为阿德福韦酯+拉米夫定组和拉米夫定组各53例。完成24周和48周治疗时,检测血清乙型肝炎病毒(HBV)DNA水平、HBV血清学标志物、肝功能变化以及不良反应的发生率,来评价阿德福韦酯的疗效及安全性。结果治疗24周时,阿德福韦酯+拉米夫定组血清HBV DNA水平,平均下降2.39 lg拷贝/mL,病毒应答率为59%,丙氨酸氨基转移酶(ALT)复常率为55%,均显著高于拉米夫定组,治疗48周时,阿德福韦酯+拉米夫定组血清HBV DNA水平平均下降2.71 lg拷贝/mL,病毒应答率为66%,ALT复常率为54%,显著优于拉米夫定组,阿德福韦酯+拉米夫定组治疗后血清HBeAg阴转率、HBeAg血清转换率及不良事件发生率与拉米夫定组相比差异无统计学意义,未发生与研究药物相关的严重不良反应。结论对于拉米夫定耐药的HBAeg(+)慢性乙型肝炎的患者加用阿德福韦酯治疗,可在病毒学及生物化学方面取得较好疗效,且安全性好。
Objective To investigate the efficacy and safety of adefovir dipivoxil in the treatment of chronic hepatitis B patients with lamivudine-resistant hepatitis B e antigen (HBeAg) (+). Methods A multicenter, randomized, double-blind and double-dummy clinical trial was conducted in which 106 patients with chronic hepatitis B who responded to lamivudine-resistant HBeAg (+) were randomly divided into two groups according to the ratio of 1: Fufang ester + lamivudine group and lamivudine group of 53 cases. At the completion of 24 and 48 weeks of treatment, serum hepatitis B virus (HBV) DNA levels, HBV serology markers, changes in liver function, and incidence of adverse reactions were measured to assess the efficacy and safety of adefovir dipivoxil. Results At 24 weeks, serum HBV DNA level decreased by 2.39 lg / mL on average in adefovir dipivoxil and lamivudine groups, and the response rate was 59%. The normalization rate of alanine aminotransferase (ALT) was 55%, were significantly higher than the lamivudine group, 48 weeks after treatment, adefovir dipivoxil group and lamivudine serum HBV DNA average 2.71 lg copy / mL, the virus response rate was 66%, ALT complex The rate of HBeAg negative conversion rate, HBeAg seroconversion rate and the incidence of adverse events after adefovir dipivoxil + lamivudine treatment were significantly higher than those of lamivudine group The difference was not statistically significant, and serious adverse drug reactions did not occur. Conclusions Adefovir dipivoxil treatment for patients with lamivudine-resistant HBAeg (+) chronic hepatitis B can achieve better efficacy and safety in virology and biochemistry.