恩替卡韦与拉米夫定对慢性乙型肝炎抗病毒作用与安全性的对照研究

Comparison of antiviral effects and safety between entecavir and lamivudine in patients with chronic hepatitis B

目的:比较恩替卡韦和拉米夫定治疗慢性乙型肝炎的抗病毒作用与安全性。方法:33例未经抗病毒治疗的慢性乙型肝炎患者随机分为2组:恩替卡韦组(16例)、拉米夫定组(17例)。恩替卡韦组与拉米夫定组的剂量分别为0.5mg/d和100mg/d。疗程为48～96周。观察两药对HBV DNA、ALT、e抗原/e抗体血清转换的影响及其所致不良反应。结果:在治疗24周和48周时,恩替卡韦组和拉米夫定组未检测到HBV DNA的病例分别为56.25%,29.41%;87.50%,29.41%。e抗原阴转率与e抗原/e抗体血清学转换率以及不良反应2组无明显差异。结论:恩替卡韦与拉米夫定比较能更有效的抑制HBV复制,不良反应与拉米夫定相似。因此,可以用于慢性乙型肝炎的长期治疗。

Objective： To compared the antiviral effects and safety ofentecavir with those oflamivudine. Methods： Thirty-three patients with no prior history of antiviral therapy were divided randomizely into two groups： entecavir group （16 cases）, and lamivudine group （17 cases）. The dosage in the entecavir group and lamivudine group was 0.5 mg/d and 100 mg/d, respectively, and the duration of therapy was 48 -96 weeks. The effects of entecavir and lamivudin On HBV DNA, ALT, HBeAg/HBeAb seroconversion, and their adverse reactions were observed during the treatment. Results： The patients with undetectable serum levels ofHBV DNA in the entecavir group were more than those in the lamivudine group, that is, 56.25% versus 29.41% on week 24, and 87.50% versus 29.41% on week 48 after treatment. There were no marked differences in the HBeAg negative conversion rate, HBeAg/HBeAb seroconverse rate, and the incidence of adverse reactions between the two groups. Conclusion： Entecavir is more effective in inhibiting reproduction of HBV than that of lamivudine, and entecavir is similar to lamivudine in the incidence of adverse reactions; therefore, entecavir could be used for long-term treatment of the patients with chronic hepatitis B.