聚乙二醇干扰素alpha-2a联合恩替卡韦治疗高病毒载量HBeAg阳性慢性乙型肝炎的临床研究  

Efficacy of Peg-interferon alpha.2a combinated with entecavir on HBeAg positive chronic hepatitis B patients with high serum hepatitis B viral loads

作　　者：曾文[1] 袁静[1] 刘映霞[1] 张影[1] 李莎茜[1] 姚思敏[1] 林益敏[1] 陈川铁[2] 赵美芬[2] 刘京[2] 刘艳[1] 周伯平[1] 

机构地区：[1]深圳市第三人民医院感染科,518112 [2]南华大学附属第一临床学院

出　　处：《中华实验和临床病毒学杂志》2013年第2期115-118,共4页Chinese Journal of Experimental and Clinical Virology

基　　金：深圳市医学重点专科资助

摘　　要：目的观察聚乙二醇干扰素alpha-2a联合恩替卡韦治疗高病毒载量HBeAg阳性慢性乙型肝炎的疗效及安全性。方法60例HBeAg阳性患者随机分成三组：聚乙二醇干扰素α-2a组20例（A组），恩替卡韦组20例（B组），聚乙二醇干扰素联合恩替卡韦组20例（c组）（联合治疗12周后单用聚乙二醇干扰素治疗）。观察三组患者治疗4、12及24周时丙氨酸氨基转移酶（ALT）复常率、HBVDNA阴转率、HBsAg和HBeAg血清转换情况，并观察其不良反应。结果分别在治疗第4、12、24周时比较三组，A组、B组的HBVDNA阴转率均明显低于c组（分别为：Z=-4．6，P〈0．0001；Z=-2．53，P=0．0114）；A组ALT复常率明显低于C组（Z=-2．63，P=0．0086），B组与C组的ALT复常率差异无统计学意义；C组的HBsAg、HBeAg下降幅度大于A组和B组。结论聚乙二醇干扰素alpha-2a联合恩替卡韦治疗高病毒载量HBeAg阳性慢性乙型肝炎患者，6个月疗程中HBVDNA阴转率、ALT复常率均优于聚乙二醇干扰素单药治疗，且安全性良好。Objective This study aimed at evaluating the efficacy and safety of a combination treatment of entecavir and Peginterferon alpha-2a for HBeAg positive chronic hepatitis B patients with high serum hepatitis B viral loads. Methods 60 treatment-naive HBeAg-positive CHB patients with high serum hepatitis B viral loads were enrolled and randomly divided into three groups： group A received Peginterferon alpha-2a monotherapy for 48 weeks （ n = 20） ; group B received entecavir monotherapy for more than 48 weeks （n = 20）; group C received Peginterferona alpha-2a combined with enteeavir for 12 weeks, then Peginterferon alpha-2a monotherapy for 36 weeks （ n = 20）. Virological response, ALT normalization, HBeAg and HBsAg seroclearance rate were analysed at the end of 4,12 and 24 weeks after the treatment. Results The ratio of undetectable hepatitis B virus（HBV）DNA were 50% and 10% , 95% and 25% and 100% and 30% in group C and group A respectively, 50% and 20% , 95% and 75% and 100% and 90% in group C and group B respectively at the end of 4,12 and 24 weeks of treatment. The differences were significant between group C and A （ Z = - 4. 6,P 〈 0. 001 ）, group C and B （ Z = - 2.53, P = 0. 0114）. ALT normalization rate was significantly lower in group A than that of group C （Z = - 2. 63,P = 0. 0086）. HBeAg levels declined more in group C than the other two groups after 24 weeks of treatment. Conclusions For HBeAg positive chronic hepatitis B patients with high serum hepatitis B viral loads, combination treament of Peginterferon alpha-2a with entecavir is more effective than Peginterferon alpha-2a monotherapy in virologic response and ALT normalization after 24 weeks of treatment.

关 键 词：干扰素Α-2B 恩替卡韦 肝炎 乙型 慢性 肝炎e抗原 乙型 

分 类 号：R51[医药卫生—内科学]