拉米夫定优化治疗与拉米夫定初始联合阿德福韦酯治疗慢性乙型肝炎的48周临床研究

Clinical study of optimization of treatment with lamivudine or de novo combination therapy with lamivudine and adefovir dipivoxil for chronic hepatitis B after 48 weeks

目的研究拉米夫定优化治疗与拉米夫定初始联合阿德福韦酯治疗慢性乙型肝炎的临床疗效。方法将98例慢性乙肝患者按随机数字表法分为优化治疗组与初始联合组，优化治疗组用拉米夫定优化疗法，初始联合组用拉米夫定初始联合阿德福韦酯进行治疗，每12周对病毒学、血清学、生物化学等指标进行检测，分析48周的疗效。结果两组患者治疗前基线情况有可比性（P〉0．05）。治疗48周初始联合组HBVDNA阴转率、e抗原阴转率、耐药率分别为86％、37％、0，优化治疗组为59％、12％、18％，差异有统计学意义（P〈0．05）。初始联合组e抗原血清转换率、ALT复常率分别为23％、91％，优化治疗组分别为6％、86％，两组差异无统计学意义（P〉0．05），两组不良反应发生率差异无统计学意义（P〉0．05）。结论初始联合组相比拉米夫定优化治疗组可取得更高的HBV．DNA阴转率、e抗原阴转率，更低耐药率，安全性较好。

Objective To investigate the clinical efficacy of the optimization of treatment with lami- vudine or de novo combination therapy with lamivudine and adefovir dipivoxil. Methods A total of 98 ca- ses of chronic hepatitis B patients were randomly divided into optimization of treatment group and de novo combination therapy group, optimization of treatment group treated with lamivudine optimization therapy, de novo combination therapy group treated with lamivudine and adefovir dipivoxil , virological, serological, bi- ochemical and other indices were detected every 12 weeks, analyzed treatment effect after 48 weeks. Re- snits Two groups were comparable baseline before treatment（ P 〉0. 05）. HBV DNA negative rate, e an- tigen-negative rate, and resistance rates at week 48 were 86%, 37%, and 0 in the de novo combination therapy group, and 59%, 12% and 18% in the optimized treatment group （ P 〈0. 05）. The e antigen se- roconversion and ALT normalization rates were 23% and 91% in the de novo combination group, and 6% and 86% in the optimized treatment group （ P 〉 0. 05）. There was similar incidence of adverse reactions. Conclusions Compared to the de novo combination therapy group, the lamiv.udine-optimized treatment group can achieve higher HBV-DNA negative rate, e antigen-negative rate, lower resistance rates, and good safety.