恩替卡韦与阿德福韦酯单药治疗HBeAg阳性慢性乙型肝炎的疗效及安全性

Efficacy and safety of entecavir and adefovir dipivoxil in treatment of HBeAg positive chronic hepatitis B

目的探讨恩替卡韦(ETV)与阿德福韦酯(ADV)单药治疗HBeAg阳性慢性乙型肝炎(CHB)的疗效及安全性。方法HBeAg阳性CHB患者82例,随机分为两组,分别采用ETV(ETV组,50例)和ADV(ADV组,32例)治疗,观察治疗前、治疗后第24、48周和第2、3、4、5、6、7、8、9、10年HBV DNA定量,以及治疗第10年HBsAg、HBeAg转阴率和HBeAg血清学转换率,同时记录两组不良反应发生情况。结果 ETV组治疗后第48周及第2、3、4、5、6、7、8、9年HBV DNA转阴率高于ADV组(P<0.05)。两组患者治疗第10年HBsAg转阴率和HBeAg血清学转换率相仿(P>0.05),ETV组HBeAg转阴率高于ADV组(84.0%vs.56.3%)(P<0.05)。ADV组中,有3例(9.4%)出现轻度肾损伤,其他患者在治疗过程中均未出现明显的不良反应。两组患者均无肝硬化和肝癌的发生。结论 ETV和ADV能延缓CHB的发展,且ETV抗病毒作用优于ADV,不良反应少。

Objective To investigate the efficacy and safety of entecavir（ETV）and adefovir dipivoxil（ADV）in the treatment of HBeAg positive chronic hepatitis B（CHB）.Methods A total of82 cases with HBeAg positive CHB was treated with ETV（group ETV,50 cases）or ADV（group ADV,32 cases）,respectively.The quantities of HBV DNA before treatment and in the 24 th and 48 th week and 2 ^（nd）,3 ^（rd）,4 ^（th）,5 ^（th）,6 ^（th）,7 ^（th）,8 ^（th）,9 ^（th） and 10 ^（th） year after treatment were detected.The negative conversion rate of HBsAg and HBeAg and serum conversion rate of HBeAg were analyzed as well.The adverse responses were recorded.Results The negative rate of HBV DNA was higher in group A than that in group B in the 48 th week and 2 ^（nd）,3 ^（rd）,4 ^（th）,5^（th）,6 ^（th）,7 ^（th）,8 ^（th） and 9 th year after treatment（P〈0.05）.In the 10 th year after treatment,the negative conversion rate of HBsAg and serum conversion rate of HBeAg were not significantly different between two groups（P〉0.05）,but the negative conversion rate of HBeAg was higher in group ETV than that in group ADV（84.0% vs.56.3%）（P〈0.05）.The slight renal injury was seen in 3 cases of group ADV.No liver cirrhosis or liver cancer happened in two groups.Conclusion Both of ETV and ADV can delay the development of CHB.Compared to ADV,ETV is more effective in antiviral effect with less adverse responses.