摘要
目的 研究以恩替卡韦（ETV）为基础,短程联用聚乙二醇干扰素-α-2a（peg-IFN-α-2a）抗病毒治疗HBeAg阳性CHB的临床疗效,并与ETV单药治疗比较,探讨两种治疗方法在临床疗效中的差异.方法 61例HBeAg阳性CHB患者在初始予以ETV 0.5 mg/d口服24周后,随机分为联合治疗组和单药治疗组,分别加用peg-IFN-α-2a 180 μg/周治疗24周或单药ETV 0.5 mg/d治疗24周.48周评估疗效.应答定义为HBeAg消失伴HBV DNA＜200 IU/mL.有应答者继续使用ETV巩固治疗至72周后停止抗病毒治疗.无应答者继续ETV治疗至96周,所有患者均随访至96周.计量资料比较采用t检验和秩和检验,计数资料比较采用x2检验和四格表法.结果 完成96周随访的患者共59例,ETV单药治疗组29例,联合治疗组30例.48周时联合治疗组和单药治疗组病毒学应答分别占20.0％（6例）和13.8％（4例;x2=0.083,P=0.773）,96周时分别占33.3％（10例）和20.7％（6例;x2=1.193,P=0.275）.联合治疗组和单药治疗组在96周时HBsAg分别降低1.05、0.34 lg IU/mL（Z=-2.972,P=0.003）;各观察时间点HBeAg在两组间差异均无统计学意义（均P＞0.05）.HBeAg清除组在基线、12周和24周的HBsAg和HBeAg水平均低于HBeAg未清除组（均P＜0.01）.结论 接受ETV治疗的患者,短程联用peg-IFN-α-2a能显著降低患者血清HBsAg水平.CHB患者抗病毒治疗前HBsAg水平,以及第12周和24周的HBsAg和HBeAg水平或可作为患者发生病毒学应答的预测指标.
Objective To investigate the efficacy of pegylated interferon alpha-2a （peg-IFN-α-2a） temporary add-on therapy during entecavir （ETV） treatment by comparing with ETV monotherapy in patients with hepatitis B e antigen （HBeAg）-positive chronic hepatitis B （CHB）,and to discuss the differences of efficacy between these two strategies.Methods Sixty-one HBeAg-positive patients with CHB were administered with ETV at initial 24 weeks and were assigned randomly to either receive a 24 weeks addition of peg-IFN-α-2a 180 μg weekly or continue on ETV 0.5 mg daily alone for 24 weeks.Response was assessed at week 48 post-treatment and defined as HBeAg loss with hepatitis B virus （HBV） DNA ＜200 IU/mL.Then the responders were asked to discontinue the antiviral treatment at week 72.Non-responders continue the antiviral treatment with ETV until 96 weeks.All included patients were followed up until 96 weeks from the baseline.Quantitative data were compared using t test or rank sum test.Categorical data were analyzed using x2 test.Results Fifty-nine patients accomplished 96 weeks study,29 with ETV alone and 30 with add-on peg-IFN-α-2a.Response at week 48 was achieved in 20.0％ （6 cases） of patients treated with add-on peg-IFN-α-2a,compared to 13.8％ （4 cases） of patients treated with ETV alone （x2 =0.083,P=0.773） ; while the response rates at week 96 was 33.3％ （10 cases） in add-on peg-IFN-α 2a group and 20.7％ （6 cases） in ETV monotherapy group （x2 =1.193,P=0.275）.At week 96,the declines of HBsAg between two regimens were 1.05 lg IU/mL and 0.34 lg IU/mL,respectively （Z=-2.972,P=0.003）.The analyses on HBeAg levels showed that there were no significant difference between two regimens at week 24,week 48,week 72 and week 96 （all P＞0.05）.Serum levels of HBsAg and HBeAg at baseline,week 12 and week 24 were significantly lower in HBeAg clearance group than non-clearance group （all P＜0.01）.Conclusions A short term add-on of peg-IFN-α-2a during ETV treatment increases H
出处
《中华传染病杂志》
CAS
CSCD
北大核心
2015年第1期14-19,共6页
Chinese Journal of Infectious Diseases
基金
国家十二五重大专项资助项目（2012ZXl0002004-003,2012ZX10002007-002003,2012ZX10002003003-012）
国家自然科学基金资助项目（81071358,81171569）
上海市学科带头人计划资助项目（12XD1403600）
感染病学国家临床重点专科项目
