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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。
Objective: To understand the clinical efficacy of the original lamivudine and imitation lamivudine in the treatment of chronic hepatitis B. Methods: Patients with chronic hepatitis B were treated with HBV DNA pairing and were given anti-virus therapy with imitation lamivudine (49 cases, experimental group) and naive lamivudine (49 cases, control group) for 1 year. Serum alanine aminotransferase (ALT), HBV DNA and HBe Ag / anti-HBe seroconversion levels at 24 weeks and 52 weeks were selected as indicators of anti-viral efficacy and drug resistance sites were detected. Results: At 52 weeks of treatment, the ALT normalization rates were 85.71% and 81.63% in the test group and the control group respectively. The rates of HBV DNA negative conversion were 91.84% and 89.80% respectively. The HBeAg seroconversion rates were 21.74% and 22.73% The number of HBV DNA non-negative cases were 4 and 5, respectively, and there were 2 cases and 1 case of YMDD mutation in test group and control group respectively. Conclusion: The original research and imitation lamivudine can effectively inhibit HBV DNA replication, and the effectiveness of the same.