替比夫定与恩替卡韦治疗HBeAg阳性慢性乙型肝炎患者的疗效及其影响因素

Efficacy and impact factors of telbivudine or entecavir treatment in patients with HBeAg-positive chronic hepatitis B

目的探讨替比夫定与恩替卡韦治疗HBeAg阳性慢性乙型肝炎第12周、24周时病毒载量对疗效的影响。方法替比夫定与恩替卡韦分别治疗35例、40例HBeAg阳性慢性乙型肝炎患者104周,用单变量分析及Logistic回归法进行变量筛选确定抗病毒治疗过程中第12周、24周病毒载量对疗效的影响。结果两组治疗104周时血清ALT复常率及HBV DNA<103拷贝/mL比例差异无统计学意义。但替比夫定组104周时血清HBeAg消失率及血清HBeAg/抗-HBe转换率优于恩替卡韦组,两组比较差异有统计学意义(P=0.045,P=0.032)。替比夫定组104周时出现病毒学突破者共6例(17%),恩替卡韦组为1例(2.5%)。用单变量分析及Logistic回归法进行变量筛选发现,在替比夫定组中ALT水平(优势比为1.00,P=0.31)与病毒学突破无关,与病毒学突破有关的独立变量为12周HBV DNA水平(优势比为5.52,P=0.01)及治疗24周HBV DNA水平(优势比为4.86,P=0.02);恩替卡韦组中与抗病毒学疗效有关的独立变量为24周HBV DNA水平(优势比为10.52,P=0.007)。结论替比夫定治疗第12周及24周HBV DNA的水平对预测抗病毒治疗的疗效有意义,24周时的HBV DNA水平是预测恩替卡韦远期疗效的较好指标。

Objective To investigate the relationship between treatment efficacy and 12, 24-week viral load during the treatment of the telbivudine and entecavir. Methods In this study,Efficacy of telhivudine or entecavir treatment for 104 weeks of patients with HBeAg- positive chronic hepatitis B was observed respectively. The levels of HBV DNA at week 12 and week 24 during treatment were determined, and the factors that predict the efficacy at week 104 were analyzed. Results 75 patients received telbivudine （n = 35） or entecavir （n = 40） were enrolled in this study. After 104 weeks of treatment, there was no significant difference in the proportion of serum ALT normalization and HBV DNA less than 103 copies/ml between the two goups. However, at week 104 of treatment, the rate of HBeAg disappearance （P = 0. 045） and HBeAg seroconversion （P = 0. 032） in telbivudine group were significantly more than that in entecavir group. HBV DNA levels at week 12 （odds ratio 5.52, P = 0.01） and week 24 （odds ratio for 4.86, P = 0.02） of treatment were the independent variables relevant to the virological breakthrough in telbivudine group; Virological breakthrough was observed in 6 patients of telbivudine treatment and 1 patient of entecavir treatment after 104 weeks, respectively. The independent variables relevant to antiviral efficacy were HBV DNA levels of at 24-week of treatment （odds ratio 10.52, P = 0. 007） in entecavir group. Conclusion These datas showed that HBV DNA levels of nucleoside analogues treatment at week 24 may significantly predict the efficacy of antiviral treatment, and also predict the long- term efficacy of entecavir treatment.