中文摘要：

目的：了解原研拉米夫定和仿制拉米夫定治疗慢性乙型肝炎的临床疗效。方法：将慢性乙型肝炎患者按HBV DNA配对,分别给予仿制拉米夫定（49例,试验组）和原研拉米夫定（49例,对照组）进行抗病毒治疗,疗程1年。选择24周和52周血清谷丙转氨酶（ALT）、HBV DNA和HBe Ag/抗HBe血清转换水平等作为评价抗病毒疗效的指标,并检测耐药位点。结果：治疗52周时,试验组和对照组ALT复常率分别为85.71%和81.63%,HBV DNA阴转率分别为91.84%和89.80%,HBe Ag血清转换率分别为21.74%和22.73%,HBV DNA未转阴的病例数分别为4和5,试验组和对照组分别有2例和1例YMDD变异。结论：原研和仿制拉米夫定均可有效抑制HBV DNA复制,且有效性相当。

英文摘要：

Objective： To evaluate the clinical efficacy of original and generic lamivudine in the treatment of chronic hepatitis B. Methods： Patients with chronic hepatitis B were matched by HBV DNA titers and divided into two groups to receive original lamivudine（ 100 mg,qd） or generic lamivudine（ 100 mg,qd） orally for one year,respectively. The two groups received same basic treatments. HBV DNA,ALT and HBe Ag seroconversion in serum were examined at baseline and 24 and 52 weeks after treatment,and DNA mutations were detected. Results： The recovery rates of serum ALT were 85. 71% and 81. 63% in the experimental group and control groups,respectively. The negative conversion rate of serum HBV DNA was higher in the experimental group than that in the control group（ 91. 84% vs 89. 80%）. The conversion rate of HBe Ag to HBe Ab was lower in the experimental group（ 21. 74% vs 22. 73%）. There were 4 and 5 patients with positive HBV DNA in the experimental group and control group,respectively. YMDD mutation was found in 1 and 2 cases in the experimental group and control group,respectively. Conclusion： Original and generic lamivudine can both inhibit the replication of HBV DNA with comparable efficacy.