拉米夫定治疗慢性乙型肝炎的随机对照研究

摘要

目的 观察拉米夫定治疗慢性乙型肝炎的的疗效.方法 采用双盲随机分组的方法将322例慢性乙型肝炎患者分为实验组(n=164)与对照组(n=158),实验组用拉米夫定(100mg/d)治疗52周,对照组用安慰剂治疗52周.比较患者在治疗过程中临床症状、体征、肝功能指标、HBeAg阴转率、HBsAg阴转率、HBeAg血清转换率等指标变化.结果 随着治疗时间的延长,实验组的ALT、AST及HBV DNA水平均逐渐降低,与对照组的差异有统计学意义.实验组的HBeAg阴转率(80.67％)、HBsAg阴转率(20.12％)、HBeAg血清转换率(61.11％)均高于对照组(9.29％,6.96％,27.50％)(P＜0.05).结论 拉米夫定治疗慢性乙型肝炎短期内疗效确切,有助于延缓慢性乙型肝炎患者的病情发展,长期疗效尚有待进一步研究.%Objective To observe the effect of lamivudine in the treatment of chronic hepatitis B. Methods 322 patients with chronic hepatitis B were divided into the treatment group and the control group by a randomized controlled way. Patients in the treatment group and the control group were treated with lamivudine (100 mg/d) with placebo (100mg/d) for 52 weeks, respectively. The changes of clinical symptoms, signs, liver function and virology indexes were compared in two groups. Results Commpared with the control group, the treatment time extent, ALT, AST and HBV DNA level in the treatment group gradually reduced, with a statistically significant difference. The treatment group's HBeAg shade rate(80.67%), HBsAg shade rate (20.12%), HBeAg conversion rate (61.11% ) were all higher than those in the control group (6.96%, 27.50%, 27.50%). Conclusion Lamivudine therapy has the positive effect on chronic hepatitis B patients in the short term, while the long-term efficacy still need further study.