恩替卡韦治疗慢性乙型肝炎的临床研究

摘要

目的 探讨恩替卡韦治疗慢性乙型肝炎的疗效和安全性.方法 选取慢性乙型肝炎患者77例,随机分为试验组和对照组.试验组给予口服恩替卡韦治疗,对照组给予口服拉米夫定治疗,疗程48周.于治疗前、治疗后12周、24周、48周观察患者的肝功能、HBsAg、HBeAg、HBV DNA等指标的变化.结果 治疗48周时,试验组和对照组ALT复常率分别为66.7%和63.2%,差异无统计学意义;试验组HBeAg阴转率和血清学转换率分别为30.8%和25.6%,高于对照组的10.5%和7.9%(P均<0.05);试验组HBV DNA阴转率为71.8%,高于对照组的44.7%(P<0.05);试验组HBsAg阴转率和血清学转换率分别为5.1%和2.6%,对照组为2.6%和0,2组差异均无统计学意义.所有患者未出现严重不良反应.结论 恩替卡韦对于慢性乙型肝炎具有显著的抗病毒作用,效果优于拉米夫定,且无严重不良反应.%Objective To investigate the efficacy and safety of entecavir in treatment of chronic hepatitis B.Methods Seventy-seven chronic hepatitis B patients were assigned into two groups (test group and control group) randomly. The test group received oral entecavir treatment, while the control group received lamivudine treatment. The total course of treatment was 48 weeks. The changes of liver function, HBsAg, HBeAg, HBV DNA and other indexes were observed before and after treatment in 12 weeks, 24 weeks and 48 weeks.Results After 48 weeks′ treatment, the ALT recovery rate of the test group and the control group were 66.7% and 63.2%, respectively. There was no statistically significant difference between the 2 groups. The HBeAg negative conversion rate and serological conversion rate of the test group were 30.8% and 25.6%, respectively, which were higher than those of the control group (10.5% and 7.9%, respectively,P<0.05). The HBV DNA negative conversion rate of the test group was 71.8%, higher than that of the control group of 44.7%. The HBsAg negative rate and serological conversion rate in the test group were 5.1% and 2.6%, while 2.6% and 0 in the control group. There was no statistically significant difference between the 2 groups. No serious adverse reactions occurred in all patients. Conclusions Entecavir has significant curative effect for chronic hepatitis B, the effect is superior to lamivudine, and has no serious adverse reactions.