【摘要】 目的探讨国产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、双模拟、活性药(拉米夫定)平行对照的研究方法,将发生YMDD变异的慢性乙型肝炎患者作为研究对象,停止原服用的拉米夫定,按1∶1比例,随机接受国产阿德福韦酯10mg联合拉米夫定安慰剂1粒或拉米夫定100mg联合阿德福韦酯安慰剂1粒治疗48周。分别观察两组血清生化学指标、HBVDNA水平、HBV血清学标志物变化以及不良反应的发生率。结果两组各有13例和14例患者分别接受阿德福韦酯和拉米夫定治疗。在治疗48周时,ALT<正常值上限患者的比例在阿德福韦酯组为92.9%(12/13),显著高于拉米夫定组的42.9%(6/14)(P=0.0065);阿德福韦酯组HBVDNAlog10水平下降幅度为(3.562±2.289),拉米夫定组下降为(1.024±2.797),两组组间相比差异有显著性(P<0.05);48周时阿德福韦酯组HBeAg转阴率和血清学转换率皆为23.1%(3/13),而拉米夫定组分别为14.3%(2/14)和7.1(1/14),但两组差异无显著性。结论国产阿德福韦酯治疗拉米夫定耐药慢性乙型肝炎的疗效肯定,安全性好。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of domestic adefovir dipivoxil in patients with hepatitis B resistant to lamivudine. Methods A randomized, double blind, double dummy, active parallel controlled study was conducted in chronic hepatitis B patients with YMDD mutation. Eligible patients stopped lamivudine therapy and were assigned to receive 10 mg of adefovir dipivoxil plus matching placebo once daily or 100 mg of lamivudine plus matching placebo once daily for 48 weeks (ratio, 1∶1). ALT level, serum HBV DNA, and hepatitis B serology markers were measured at regular intervals, the adverse events were recorded. Results 13 patients were received adefovir dipivoxil and 14 patients received lamivudine. After 48 weeks of treatment normalization of ALT levels in patients who received adefovir dipivoxil was 92.9% and in patients who received lamivudine was 42.9%, respectively, P=0.0065. The median decrease in log-transformed HBV DNA levels was greater with adefovir dipivoxil treatment than with lamivudine (3.562±2.289 vs. 1.024±2.797 log copies per milliliter, P<0.05). The both rates of HBeAg loss and HBeAg seroconversion were 23.1%(3/13)in adefovir dipivoxil treatment group, in lamivudine treatment group,it were 14.3%(2/14)and 7.1%(1/14), respectively, There was no significant statistical difference in HBeAg loss rate and HBeAg seroconversion rate between two groups. Conclusion Domestic adefovir dipivoxil was well tolerated and safe, and demonstrated a potent antiviral response in lamivudine-resistant patients with chronic hepatitis B.更多还原