临床试验PEG干扰素alpha-2a治疗慢性乙肝的有效性和耐受性

肝胆速递

Efficacy and tolerability of pegylated interferon-α-2a in chronic hepatitis B: A multicenter clinical experience
多临床中心试验PEG干扰素alpha-2a治疗慢性乙肝的有效性和耐受性

肝胆速递：PEG干扰素可耐受每日使用且有效


Journal of Gastroenterology and Hepatology  Vol 27 Issue 9

Efficacy and tolerability of pegylated interferon-α-2a in chronic hepatitis B: A multicenter clinical experience

    Dilip Ratnam1,2,*,
    Anouk Dev1,2,
    Tin Nguyen3,
    Vijaya Sundararajan2,
    Hugh Harley4,
    Wendy Cheng5,
    Alice Lee6,
    Ferry Rusli1,
    Robert Chen3,
    Sally Bell3,
    Stephen Pianko1,
    William Sievert1,2

Article first published online: 21 AUG 2012

DOI: 10.1111/j.1440-1746.2011.07051.x
Author Information

    1    Gastroenterology and Hepatology Unit, Monash Medical Centre, Australia
    2    Department of Medicine, Monash University, Clayton, Australia
    3    Department of Gastroenterology, St Vincent's Hospital, Fitzroy, Victoria, Australia
    4    Department of Gastroenterology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
    5    Department of Gastroenterology and Hepatology, Royal Perth Hospital, Perth, Western Australia, Australia
    6    Department of Gastroenterology and Hepatology, Concord Repatriation Hospital, Sydney, New South Wales, Australia

*Dr Dilip Ratnam, Department of Gastroenterology and Hepatology, Monash Medical Centre, 246 Clayton Road, Clayton, Vic. 3168, Australia. E-mail: [email protected]


Abstract

Background and Aim:  Pegylated interferon-α (PEG-IFN) provides potential advantages over nucleos(t)ide analogues in the treatment of chronic hepatitis B (CHB) given its finite course, durability and lack of drug resistance. Much of the evidence is derived from controlled studies and it is unclear whether these results can be replicated in an everyday, non-controlled setting. The aim of this study was to examine the efficacy and tolerability of PEG-IFN-α2A in CHB patients in a clinical setting.

Methods:  Chronic hepatitis B patients treated with PEG-IFN-α2A (180 µg/week, 48 weeks) at five tertiary hospitals were retrospectively identified. Baseline demographic and clinical data, on-treatment virological and serological responses and adverse events (AE) were recorded. Treatment outcomes were defined as alanine aminotransferase (ALT) normalization, hepatitis B virus DNA < 351 IU/mL and hepatitis B e antigen (HBeAg) seroconversion.

Results:  Sixty three HBeAg positive patients were identified (65% male, 80% born in Asia, 84% with viral loads > 6log IU/mL, 9.5% advanced fibrosis). Six months after therapy 46% achieved normalization of ALT, 16% had viral loads < 351 IU/mL and 32% achieved HBeAg seroconversion. 29 HBeAg negative patients were treated (75% male, 86% born in Asia, 48% had viral loads > 6log IU/mL, 24% advanced fibrosis). Six months post-treatment, 55% and 36% maintained a normalized ALT and HBV DNA < 351 IU/mL, respectively. Optimal viral suppression was maintained in 50–75% of patients over 2 years of follow up. 6.5% of all patients discontinued therapy due to AEs.

Conclusion:  In everyday clinical practice PEG-IFN therapy in CHB is well tolerated and can achieve a similar efficacy to that seen in large controlled trials.

肝胆速递

胃肠病学和肝病学杂志 第27卷第9期

聚乙二醇化干扰素α-2a在慢性乙型肝炎的疗效和耐受性的多中心临床经验

    迪利普Ratnam1，2，*，
    阿努克DEV1，2，
    天Nguyen3，
    维贾雅Sundararajan2，
    休Harley4，
    温迪Cheng5，
    爱丽丝Lee6，
    渡轮Rusli1，
    罗伯特Chen3，
    莎莉Bell3，
    斯蒂芬Pianko1，
    了威廉Sievert1，2

在网上公布：2012年8月21日

DOI：10.1111/j.1440-1746.2011.07051.x
作者信息

    1 胃肠病学和肝病学组，澳大利亚Monash医学中心，
    2 克莱顿，澳大利亚莫纳什大学，医学系，
    3 消化内科，圣云仙医院，菲茨罗伊，维多利亚，澳大利亚
    4 澳大利亚，南澳大利亚阿德莱德皇家阿德雷德医院，消化内科
    5 胃肠病学和肝病学系，珀斯皇家医院，珀斯，西澳大利亚，澳大利亚
    6 胃肠病学和肝病学杂志，协和遣返医院，悉尼，新南威尔士州，澳大利亚

迪利普·拉特纳姆博士，胃肠病学和肝病学系，Monash医学中心，246克莱顿，克莱顿，维克。 3168，澳大利亚。电子邮件：dilip.ratnam monash.edu


抽象

背景和目的：聚乙二醇化α-干扰素（PEG-IFN）提供了潜在的优势核苷（酸）类似物治疗慢性乙型肝炎（CHB）由于其有限的课程，耐用​​性和耐药性缺乏。大部分的证据来自对照研究，目前还不清楚是否这些结果可以被复制在我们的日常生活中，非控制设定。本研究的目的是探讨慢性乙型肝炎患者，在临床上的疗效和耐受性的PEG-IFN-α2A。

方法：PEG-IFN-α2A（180微克/周，48周），5个三级医院治疗的慢性乙肝患者进行回顾性分析。基线人口统计学和临床​​资料，对治疗的病毒学和血清学反应和不良事件（AE）的记录。治疗结果被定义为丙氨酸氨基转移酶（ALT）正常化，乙肝病毒DNA <351 IU / mL和B型肝炎e抗原（HBeAg）血清转换。

结果：63例HBeAg阳性患者（65％为男性，80％出生在亚洲，84％的病毒载量> 6log IU /毫升，9.5％的晚期肝纤维化）。治疗6个月后，有46％的ALT恢复正常，16％的病毒载量<351 IU / mL和32％的HBeAg血清学转换。 29治疗HBeAg阴性患者（75％为男性，86％出生在亚洲，48％的病毒载量> 6log IU / mL时，24％的晚期肝纤维化）。六个月后处理，保持了55％和36％，ALT复常和HBV DNA <351 IU /毫升，分别。最佳的病毒抑制维持在50％至75％的患者超过2年的随访。 6.5％的患者停止治疗，由于不良事件。

结论：在日常临床实践中，PEG-IFN治疗慢性乙型肝炎的耐受性良好，可以实现类似的效果在大型对照试验中所看到的。

咬牙硬挺

还是不够好，啥时能毕其功于一役啊。