恩替卡韦治疗慢性乙型肝炎的临床对照研究

摘要

目的 探讨恩替卡韦治疗慢性乙型肝炎(CHB)的疗效.方法 将125例CHB患者随机分为恩替卡韦组(n=65)和拉米夫定组(n=60),分别应用恩替卡韦和拉米夫定抗病毒治疗,疗程为48周,观察2组的疗效、病毒耐药率及不良反应等.结果 恩替卡韦组HBeAg阳性患者丙氨酸氨基转移酶(ALT)复常率、HBV DNA下降的log对数值、HBV DNA转阴率、HBeAg转阴率均优于拉米夫定组HBeAg阳性患者(P<0.05).2组HBeAg阳性患者间HBeAg/抗-HBe血清转换率差异无统计学意义(P＞0.05).2组HBeAg阴性患者间ALT复常率、HBV DNA下降的log对数值、HBV DNA转阴率差异无统计学意义(P＞0.05).恩替卡韦组治疗48周时病毒耐药率低于拉米夫定组(P<0.05).2组治疗过程中不良反应发生率差异无统计学意义(P>0.05).结论 恩替卡韦治疗48周对HBeAg阳性CHB患者的疗效优于拉米夫定,且病毒耐药率低于拉米夫定,但HBeAg/抗HBeAg转换率无明显差异.2种药物对HBeAg阴性CHB患者的疗效无明显差异.%Objective To observe the therapeutic effect of entecavir for chronic hepatitis B ( CHB). Methodsrn125 cases of CHB were randomly divided into entecavir (ETV) group ( n = 65) and lamivudine (LVD) group (n = 60). All the patients in both groups received ETV or LVD treatment for 48 weeks. The clinical efficacy , virus resistance rate and adverse reaction between the 2 groups were compared. Results Compared with the HBeAg positive patients in LVD group , the HBeAg positive patients in ETV group had a higher alanine aminotransferase (ALT) recovery rate , greater decline on logarithm value of HBV DNA , higher HBV DNA negative rate , and higher HBeAg negative rate (P < 0. 05 ). The HBeAg/Anti - HBe seroconversion rate between HBeAg positive patients of the 2 groups showed no significant difference ( P > 0. 05 ). No significant differences of ALT recovery rate , decline on logarithm value of HBV DNA , HBV DNA negative rate, and HBeAg negative rate were observed in the HBeAg negative patients between the 2 groups (P > 0. 05 ). After 48 weeks of treatment, the virus resistance rate was lower in ETV group than in LVD group (P > 0. 05). No significant difference of adverse reaction rate during treatment was observed between the 2 groups (P >0. 05 ). Conclusion 48 weeks of ETV therapy for HBeAg positive CHB patients is more effective than LVD therapy , with lower virus resistance rate in ETV therapy. However, there is no significant difference in the HBeAg/Anti - HBe seroconversion rate between ETV and LVD therapy. There is no significant difference in the therapeutic effect of ETV and LVD therapy for HBeAg negative CHB patients.