恩替卡韦与拉米夫定治疗e抗原阳性慢性乙型病毒性肝炎的临床研究

Clinical efficacy of entecavir and lamivudine on HBeAg positive chronic hepatitis B patients

目的评价恩替卡韦治疗e抗原阳性慢性乙型病毒性肝炎的临床疗效和安全性。方法 80例乙型肝炎e抗原(HBeAg)阳性慢性乙肝患者随机分为恩替卡韦组(试验组)和拉米夫定组(对照组),各40例。试验组口服恩替卡韦片500 mg·d-1,对照组口服拉米夫定片100 mg·d-1,疗程均为48周,比较2组患者在8,12,24,36,48周时谷丙转氨酶(ALT)复常率、乙肝病毒DNA(HBV-DNA)低于下限率和HBe Ag血清学转换率,且观察治疗期间2组患者的不良反应。结果在第8,12周时,试验组谷丙转氨酶复常率为47.50%,65.00%,明显高于对照组的25.00%,42.50%(P<0.05);试验组在各时间点HBV-DNA低于下限率均明显高于对照组(P<0.05);36,48周时,试验组HBe Ag血清学转换率为32.50%,35.00%,明显高于对照组的12.50%,15.00%(P<0.05)。2组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HBe Ag阳性慢性乙肝疗效好,不良反应发生率低。

Objective To explore the effect and safety of entecavir and lamivudine on patients with hepatitis B e antigen（ HBe Ag） positive chronic hepatitis B. Methods A total of 80 patients with HBe Ag positive chronic hepatitis B were randomly divided into trial group and control group,with 40 cases each. The patients in trial group were given entecvir500 mg·d-1; and those in the control group were given lamivudine 100mg·d-1. The treatment course of both groups was 48 weeks. The data of ALT normalization rate,rate of undetectable HBV DNA and HBe Ag seroeonversion rate in two groups at the 8th,12 th,24th,36 thand 48thweek after treatment were compared as well as the differences of adverse reactions during treatment. Results The ALT normalization rate in trial group was 47. 50%,65. 00% at the 8th,12 thweek,significantly higher than those of the control group（ 25. 00%,42. 50%）（ P〈0. 05）. The rate of undetectable HBV DNA in trial group was significantly higher than control group at each time point（ P〈0. 05）. The HBe Ag seroconversion rate was 32. 50%,35. 00% at the 36 thand 48thweek in trial group,significantly higher than that of the control group（ 12. 50%,15. 00%）（ P〈0. 05）. The incidence of adverse reactions between the two groups had no statistical difference（ P〈0. 05）. Conclusion The entecavirtreatment for HBe Ag positive chronic hepatitis B patients is with good curative effect,lower incidence of adverse reactions.