恩替卡韦治疗慢性乙型肝炎的临床对照研究

Clinical controlled study on entecavir therapy for chronic hepatitis B

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、HBVDNA下降的log对数值、HBVDNA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阳性患者问I-IBeAg／抗一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A坍复常率、HBVDNA下降的log对数值、HBVDNA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）. Methods 125 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 de- cline on logarithm value of HB~＂ DNA, higher HB~ 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 nega- tive rate, and HBeAg negative rate were observed in the HBeAg negative patients between the 2 groups （P 〉 0.05）. Af- ter 48 weeks of treatment, the virus resistance rate was lower in ETV group than in LVD group （P 〉 0.05 ）. No signifi- cant 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.