恩替卡韦治疗HBeAg阳性慢性乙型肝炎患者96周临床研究

目的 研究恩替卡韦治疗HBeAg阳性的慢性乙型肝炎患者的疗效及安全性.方法 94例初次行抗病毒治疗的HBeAg阳性慢性乙型肝炎患者随机分为两组,恩替卡韦组54例,拉米夫定组40例,分别给予恩替卡韦0.5 mg/d,拉米夫定100 mg/d,疗程96周.评估患者丙氨酸氨基转移酶(ALT)复常率、HBV-DNA转阴率、血清学标志和安全性方面的情况.结果 疗程结束时恩替卡韦组ALT复常率为94.3%,HBV-DNA转阴率(HBV-DNA<1000拷贝/ml)83.0%;拉米夫定组ALT复常率和HBV-DNA转阴率分别为76.3%和60.5%,两组之间比较差异有统计学意义.而HBeAg转阴率和HBeAb阳转率两组之间比较差异无统计学意义.结论 在初治患者中,恩替卡韦治疗96周ALT复常率和HBV-DNA阴转率优于拉米夫定,且安全性良好,耐药发生率低.Abstract：Objective To investigate the efficacy and safety of entecavir in treating patients with HBeAg-positive chronic hepatitis B. Methods Ninety-four cases of HBeAg-positive chronic hepatitis B with no prior history of antiviral therapy were randomly divided into two groups:entecavir group (54 cases) treated with entecavir 0.5 mg/d and cami vudine group (40 cases) treated with lamivudine 100 mg/d.The duration of both therapy were 96 weeks.The ALT normalization rate,HBV-DNA negative conversion rate,HBeAg seroconversion and safty were assessed. Results At the end of the therapy,the ALT normalization rates of entecavir group and lamivudine group were 94.3% and 76.3%,respectively. The HBV-DNA negative conversion rates were 83.0% and 60.5%,respectively.There were significant differences between the two groups.But there was no significant difference in HBeAg negtive conversion rate and HBeAb seroconvesion rate between the two groups. Conclusions The ALT normalization rate and HBV-DNA negative convesion rates of nucleoside naive patients with HBeAg-positive chronic hepatitis B treated by ente cavir for 96 weeks are higher than treated by lamivudine,and the treatment of entecalir is safe and has low incidence of drug resistance.

Clinical study of patients with HbeAg-positive chronic nepatitis B treated by entecavir for 96 weeks

Hepatitis B virus Chronic hepatitis B Entecavir Lamivudine