聚乙二醇干扰素α-2a联合恩替卡韦治疗HBeAg阳性慢性乙型肝炎的临床研究

Efficacy and Safety of Pegylated-interferonα-2a Plus Entecavir in HBeAg Positive Chronic Hepatitis B Patients

目的:观察聚乙二醇干扰素α-2a(Peg-IFNα-2a)联合恩替卡韦(ETV)延长疗程至96周治疗HBeAg阳性慢性乙型肝炎(CHB),随访24周的疗效。方法:165例HBeAg阳性CHB患者分为2组:A组67例,Peg-IFNα-2a联合ETV治疗;B组98例,ETV治疗。疗程96周。在治疗的12、24、48、72、96周及随访24周时检查ALT、HBV DNA、HBeAg、HBsAg。结果:两组患者HBeAg血清学转换率比较:在治疗的48、72、96周及随访24周时,P均<0.01,差异有统计学意义;HBsAg血清学转换率比较:在治疗的48周,P<0.05,在72、96及随诊24周,P均<0.01,差异有统计学意义。结论:Peg-IFNα-2a联合ETV并延长疗程可提高HBeAg阳性CHB患者HBeAg及HBsAg血清学转换率。

Objective：To investigate the efficacy of a 96-week course of Peg-IFNα-2a and entecavir（ETV）combination therapy for achieving seroconvesion at 24 weeks after completion in patients with chronic hepatitis B（CHB）.Methods：A total of 165 CHB patients with positivity for hepatitis B e antigen（HBeAg）were randomly divided into two groups（A,B）.67 patients in group A were treated with Peg-IFNα-2aand ETV.89 patients in group B were treated with ETV.All patients were treated for rates of conversion to HBV DNA negative status,alanine aminotransferase（ALT）normalization,HBeAg and HBsAg seroconversion.Results：The rates of HBeAg serconversion were significantly different between the two groups at treatment weeks 48,72 and 96,at 24 weeks after treatment completion,all P〈0.01.The rates of HBsAg serconversion were significantly different between the two groups at 48weeks（P〈0.05）,the rates of HBsAg serconversion were significantly different between the two groups at treatment weeks 72 and 96,at 24 weeks after treatment completion,all P〈0.01.Conclusion：Prolonged Peg-IFNα-2aplus ETV combination therapy can significantly improve the rates of HBeAg and HBsAg seroconversion in HBeAg positive CHB patients.