聚乙二醇干扰素ɑ-2a治疗ALT<2ULN HBeAg阴性慢性乙型肝炎48周临床研究

The clinical efficacy of peginterferon alfa-2a in HBeAg-negative and ALT < 2ULN chronic hepatitis B patients

目的:观察聚乙二醇干扰素ɑ-2a治疗ALT<2ULN和肝组织学炎症活动度≥G2的HBeAg阴性慢性乙型肝炎患者的疗效。方法:采用随机、开放、对照的方法,33例ALT<2ULN肝组织学炎症≥G2的HBeAg阴性慢性乙肝分为聚乙二醇干扰素ɑ-2a组16例和恩替卡韦对照组17例,分别接受48周的治疗。治疗24周、48周进行评估。结果:治疗48周,聚乙二醇干扰素α-2a组和恩替卡韦组血清HBVDNA阴转率分别是68.8%和76.7%,比较差异无统计学意义(P>0.05),两组血清HBVDNA水平与基线相比,分别下降(2.71±1.43)lgcopies/mL和(2.88±1.03)lgcopies/mL,差异无统计学意义(P>0.05)。聚乙二醇干扰素α-2a组有1例HBsAg阴转,恩替卡韦组没有1例HBsAg阴转或血清转换。成对活检患者,聚乙二醇干扰素α-2a组和恩替卡韦组肝组织学改善分别是37.5%和60.0%,两组差异具有统计学意义(P<0.05)。聚乙二醇干扰素α-2a组治疗后肝组织内HBsAg、HBcAg量明显减少,两组差异无统计学意义(P>0.05)。结论:聚乙二醇干扰素α-2a治疗ALT<2ULN且肝组织学检查≥G2的HBeAg阴性慢性乙型肝炎患者可获得良好的病毒学应答和组织学改善。

Objective To investigate the clinical efficacy of Peginterferon alfa-2a in chronically HBV- infected patients with HBeAg negative, ALT 〈 2ULN and the inflammation activity 1〉 G2 in liver. Methods 33 patients were randomly divided into 2 groups and treated with Peginterferon alfa-2a （ 16 patients） and Entecavir （ 17 patients） for 48 weeks respectively. And the clinical efficacy was assessed after 24 and 48 weeks of the treatment. Results After 48 weeks of treatment, serum HBV DNA turn-negative rate for Peginterferon alfa-2a and Entecavir was 68.8% and 76.7% respectively, but no statistically significant difference （P 〉 0.05）. Compared to the baseline level, the serum HBV DNA decreased （2.71 ± 1.43）lg copies/mL in Peginterferon alfa-2a treated group and （2.88 ± 1.03）1g copies/mL in Entecavir group, no statistically significant differences （P 〉 0.05）. 1 of 16 patients treated with Peginterferon Alfa-2a became HBsAg negative, while no change was observed in the Entecavir group. After 48 weeks of treatment, liver biopsy revealed that the liver tissue improvement rate of Pegintefferon alfa-2a group and Enteeavir group was 37.5% and 60.0% respectively, with statistically significant difference （P 〈 0.05）. And Peginterferon alfa-2a treatment resulted in dramatically reduced expression of HBsAg and HBcAg in the liver tissue, but there was no significant difference between these two groups （P 〉 0.05）. Conclusion Peginterferon alfa-2a has a good clinical efficacy and tissue improvement in chronically HBV infected patients with HBeAg negative, ALT 〈 2ULN, and the inflammation activity in the liver tissue≥ G2.