国产聚乙二醇干扰素α－2b 治疗 HBeAg 阳性慢性乙型肝炎的疗效和安全性  

Efficacy and safety of peginterferon α-2b in treatment of HBeAg-positive chronic Hepatitis B

作　　者：齐明华[1] 彭雁忠[1] 胡国信[1] 陈丽嘉[1] 武敬[1] 王凤卿[1] 石鑫[1] 林晓华[1] 罗艳芳[1] 张三娥[1] 胡敏[1] 岳春霞[1] 黄清清[1] 刘祝荣[1] 陈静[1] 

机构地区：[1]北京大学深圳医院感染性疾病科,518036

出　　处：《中华临床感染病杂志》2016年第3期255-259,共5页Chinese Journal of Clinical Infectious Diseases

摘　　要：目的：探讨 Peg IFNα－2b（派格宾）治疗 HBeAg 阳性慢性乙型肝炎（CHB）的疗效和安全性。方法选择2013年11月1日至2014年1月11日北京大学深圳医院门诊的 HBeAg 阳性 CHB患者32例，所有患者按2∶1中央随机分为派格宾治疗组（22例）和派罗欣治疗组（10例），分别使用Peg IFNα－2b（派格宾）和 Peg IFNα－2a（派罗欣）治疗（180μg，每周1次，皮下注射），疗程48周，停药后观察24周，期间定期检测 HBV 标志物、HBV DNA 载量和肝功能。根据是否发生 HBeAg 血清学转换和 HBV DNA 载量判断抗病毒疗效，并追踪临床试验期间观察到的不良事件和严重不良事件。采用 Fisher 确切概率法比较两组的疗效和不良反应发生率。结果治疗结束时及随访24周，派格宾治疗组和派罗欣治疗组的 ALT 复常率、HBV DNA 转阴率和 HBeAg 血清学转换率比较差异均无统计学意义（P 值均＞0．05）。两组不良反应发生率差异亦无统计学意义（P ＞0．05），但派格宾治疗组有7例患者发生视网膜病变，而派罗欣治疗组未发现类似不良反应。结论对于 HBeAg 阳性的 CHB 患者，派格宾与派罗欣治疗的疗效及安全性相近。Objective To assess the efficacy and safety of peginterferon （ PegIFN） α-2b in treatment of HBeAg-positive chronic hepatitis B （ CHB）.Methods Thirty two patients with HBeAg-positive CHB admitted in Peking University Shenzhen Hospital during November 2013 and January 2014 were recruited in the study.Patients were center randomly assigned into two groups ： 22 patients in test group were treated with 180 μg PegIFN α-2b, 1 /w for 48 wk; 10 patients in control group were treated with 180 μg PegIFN α-2a （Pegasys）, 1 /w for 48wk.All patients were followed up for 24wk after treatment.Virology markers, HBV DNA levels and liver functions were monitored regularly , and adverse events were observed . Fisher’s exact test was used to compare the efficacy and safety between two groups .Results There were no statistically significant differences between the control group and test group in ALT normalization rates , HBV DNA negative rates and HBeAg serological conversion rates both at the end of treatment and at the end of 24-wk follow-up （all P 〉0.05）.Both groups had similar adverse effect incidence rates （P 〉0.05）, but retina disease occurred in 7 cases of test group, which was not observed in control group .Conclusion Compared with PegIFN α-2a, PegIFN α-2b has similar efficacy and safety for patients with HBeAg -positive CHB.

关 键 词：干扰素类 肝炎 乙型 慢性 肝炎 e 抗原 乙型 有效性 安全性 

分 类 号：R512.62[医药卫生—内科学]