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目的分析恩替卡韦与拉米夫定治疗e抗原阳性慢性乙型肝炎患者疗效的差异,为e抗原阳性慢性乙型肝炎初治患者提供合理的治疗方案。方法选择e抗原阳性慢性乙型肝炎患者155例,随机分为2组:恩替卡韦组79例和拉米夫定组76例。均治疗24个月,对比不同治疗时间点两组ALT复常率、HBeAg转阴率及HBV-DNA转阴率。结果恩替卡韦组在治疗第3、6个月时ALT复常率为36.7%、75.9%,拉米夫定组为38.2%、75.0%,两组差异无统计学意义,治疗12个月后两组ALT均恢复正常水平;治疗第3、6、12、24个月时,恩替卡韦组的HBV-DNA转阴率为29.1%、51.9%、77.2%,78.5%,拉米夫定组为19.7%、32.9%、48.7%,39.5%,两组差异有统计学意义(均P<0.01);治疗第3、6、12、24个月时,恩替卡韦组HBeAg转阴率为0、5.1%、22.8%、36.7%,拉米夫定组为0、2.6%、17.1%、26.3%,两组有差异有统计学意义(均P<0.01)。两组均未发现严重的不良反应。结论恩替卡韦与拉米夫定治疗e抗原阳性慢性乙型肝炎在肝酶复常率方面差异无统计学意义,但在HBeAg转阴率及HBV-DNA转阴率方面的疗效恩替卡韦明显优于拉米夫定。
Objective To analyze the curative effect of entecavir and lamivudine on patients with e antigen positive chronic hepatitis B and to provide a reasonable treatment plan for patients with e antigen positive chronic hepatitis B. Methods 155 patients with e antigen positive chronic hepatitis B were randomly divided into 2 groups: 79 patients in entecavir group and 76 patients in lamivudine group. All patients were treated for 24 months. The rates of abnormal ALT, HBeAg negative rate and HBV-DNA negative rate were compared between two groups at different time points. Results The rates of ALT abnormalities were 36.7% and 75.9% in the entecavir group at 3 and 6 months, 38.2% and 75.0% in the lamivudine group, respectively. There was no significant difference between the two groups after treatment for 12 months ALT were returned to normal levels; HBV-DNA negative rates of entecavir group were 29.1%, 51.9%, 77.2% and 78.5% at 3, 6, 12 and 24 months, 19.7% in lamivudine group, 32.9%, 48.7% and 39.5%, respectively (all P <0.01). At the 3rd, 6th, 12th and 24th months of treatment, HBeAg negative rates in entecavir group were 0, 5.1% and 22.8% , 36.7% in the lamivudine group, and 0,2.6%, 17.1% and 26.3% in the lamivudine group, respectively (all P <0.01). No serious adverse reactions were found in either group. Conclusion There is no significant difference in the rate of normalization of liver enzymes between entecavir and lamivudine in the treatment of e antigen positive chronic hepatitis B, but the effect of entecavir on negative rate of HBeAg and HBV-DNA negative rate is obviously better than Lamivudine Fuding.