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Efficacy and safety of interferon-α given additionally or sequentially after long-term entecavir therapy in treatment of chronic hepatitis B
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摘要:
目的探讨经恩替卡韦（ETV）长期治疗,有效抑制HBV DNA后,采取序贯或联合IFNα治疗与单用ETV治疗的疗效与安全性比较。方法收集2013年1月-2015年12月南通大学附属吴江医院门诊和住院的慢性乙型肝炎患者27例,所有患者已经ETV抗病毒治疗3年或以上,HBV DNA阴性,无IFN治疗禁忌证,将纳入患者随机分为3组,每组9例。对照组:继续ETV治疗;序贯组:更换为IFNα序贯治疗;联合组:联合IFNα治疗。检测治疗0、12、24、36、48周时血清HBV DNA、HBV血清标志物、血常规、肝功能,观察治疗情况,记录结果并进行统计分析。计量资料多组间比较采用单因素方差分析,进一步两两比较采用Scheffe检验。结果无退出研究病例,无严重不良事件发生;序贯组有1例24周后出现了病毒反弹,但无临床症状,肝功能各项生化指标正常。治疗结束时,序贯组和联合组HBsAg下降的绝对值均显著高于对照组（P值均<0.001）;序贯组和联合组各有2例出现了HBsAg的阴转,阴转率22%;对照组未出现HBsAg的阴转病例。结论 ETV有效抑制病毒复制后的IFNα序贯或联合治疗可能是安全的,HBs...
Abstract:Objective To investigate the efficacy and safety of interferon-α (IFN-α) given additionally or sequentially after effective inhibition of HBV DNA by long-term entecavir (ETV) therapy versus ETV alone in the treatment of chronic hepatitis B (CHB) .Methods A total of 27 CHB patients with negative HBV DNA who were admitted to department of infectious diseases in Wujiang Hospital Affiliated to Nantong University from January 2013 to December 2015 had been treated with ETV antiviral therapy for 3 or more years and had no contraindications for IFN-α therapy were enrolled and randomly divided into three groups, with 9 patients in each group.The patients in the control group were given ETV alone, those in sequential group were given IFN-α sequentially after ETV therapy, and those in the combination group were given IFN-α additionally after ETV therapy.Serum HBV DNA, HBV serum markers, routine blood test, and liver function were measured at 0, 12, 24, 36, and 48 weeks of treatment.The patients' treatment outcomes were observed and a statistical analysis was performed.A one-way analysis of variance was used for comparison between multiple groups, and the Scheffe test was used for further comparison between two groups.Results There were not drop-outs, and no patient experienced serious adverse reactions.One patient in the sequential group experienced viral rebound after 24 weeks of treatment without any clinical symptoms and had normal liver function parameters.At the end of treatment, the sequential group and the combination group had a significantly higher absolute value of the reduction in HBsAg than the control group (both P < 0.001) .Two patients each in the sequential group and the combination group achieved HBsAg clearance, resulting in a clearance rate of 22%.No patient in the control group achieved HBsAg clearance.Conclusion IFN-α given additionally or sequentially after effective inhibition by ETV is safe and may achieve a significantly greater reduction in HBsAg than ETV alone.A few patients even achieve clinical cure.
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Key words:
- hepatitis B, chronic /
- hepatitis B surface antigens /
- entecavir /
- interferon-alpha /
- therapy
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