维生素E治疗儿科e抗原阳性慢性乙型肝炎：一项随机二期对照

StephenW

Vitamin e for the treatment of e-antigen positive chronic hepatitis b in pediatric patients: results of a randomized phase 2 controlled study

    Sirio Fiorino1,2, Elisabetta Loggi1, Gabriella Verucchi1, Donatella Comparcola3, Ranka Vukotic1, Michele Pavoni1, Elena Grandini1, Carmela Cursaro1, Silvia Maselli4, Maria Letizia Bacchi Reggiani5, Cristina Puggioli4, Lorenzo Badia1, Silvia Galli6, Pierluigi Viale1, Mauro Bernardi1 andPietro Andreone1,*

DOI: 10.1111/liv.13192

This article is protected by copyright. All rights reserved.

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Cover image for Vol. 36 Issue 7
Liver International


    1    Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy
    2    Unità Operativa di Medicina Interna, Ospedale Maggiore, AUSL Bologna, Bologna, Italy
    3    Unità Operativa Malattie Epatometaboliche, Ospedale Pediatrico del Bambin Gesù, Rome, Italy
    4    Unità Operativa di Farmacia Clinica, Azienda Ospedaliero Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy
    5    Unità Operativa Malattie Cardiovascolari, Università di Bologna, Bologna, Italy
    6    Unità Operativa di Microbiologia e Virologia, Azienda Ospedaliero Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy

* Contact name:
Pietro Andreone MD
Dipartimento di Scienze Mediche e Chirurgiche, Università degli Studi di Bologna
Via Massarenti 9, 40138 Bologna, Italy
Tel: 00390512143618; Fax: 0039051345806
Email: [email protected]

    This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/liv.13192


Keywords:

    Chronic Hepatitis Bediatric Infection;Vitamin E;Treatment

Abstract
Background & Aims

The treatment of chronic hepatitis B infection (CHB) in children is still an area of great uncertainty. Vitamin E is an immunostimulating/antioxidant compound proven to be safe and effective for the treatment of adult CHB. The aim of this phase 2 controlled study was to evaluate the safety and efficacy of vitamin E for the treatment of pediatric HBeAg-positive CHB.
Methods

Forty-six children were randomized in a 1:1 ratio to receive vitamin E at a dose of 15 mg/kg/day (in galenic preparation) or no treatment for 12 months and were monitored for the subsequent 12 months. Clinical, biochemical, hematological and sero-virological evaluations were carried out every 3 months.
Results

No significant side effects were associated with the vitamin E treatment. At the end of the study, anti-HBe seroconversion were obtained in 7/23 (30.4%) of vitamin E-treated versus 1/23 (4.3%) of the control patients (p=0.05), while a virological response (≥2 log decrease in HBV-DNA from baseline) was observed in 9/23 (39.1%) versus 2/23 (8.7%), respectively (p=0.035). Conclusions: Vitamin E administration for the treatment of pediatric CHB at the tested dosage has no significant side effects and may induce anti-HBe seroconversion. Vitamin E could represent a tool for the treatment of pediatric CHB.

This article is protected by copyright. All rights reserved.

StephenW

在儿科患者的治疗e抗原阳性慢性乙型肝炎的维生素E：一项随机二期对照研究结果
在儿科患者的维生素E治疗儿科e抗原阳性慢性乙型肝炎的维生素E：一项随机二期对照研究结果
    西里奥Fiorino1,2，伊丽莎白Loggi1，加布里埃拉Verucchi1，多纳泰拉Comparcola3，Ranka Vukotic1，米歇尔Pavoni1，埃琳娜Grandini1，卡梅拉Cursaro1，西尔维娅Maselli4，玛丽亚·莱蒂齐亚Bacchi Reggiani5，克里斯蒂娜Puggioli4，洛伦佐Badia1，西尔维娅Galli6，皮耶路易吉Viale1，毛罗Bernardi1 andPietro Andreone1 *

DOI：10.1111 / liv.13192

本文由版权保护。版权所有。

问题
封面图片的卷。 36问题7
肝国际


    1 Dipartimento迪Scienze MedicheêChirurgiche，博洛尼亚大学，意大利博洛尼亚
    2Unità广场Operativa迪MEDICINA INTERNA，Ospedale马焦雷，AUSL博洛尼亚，博洛尼亚，意大利
    3Unità广场Operativa Malattie Epatometaboliche，Ospedale Pediatrico德尔Bambin隔宿，罗马，意大利
    4Unità广场Operativa迪FARMACIACLÍNICA，Azienda与Ospedaliero Universitaria博洛尼亚，位于Policlinico Sant'Orsola-马尔皮基，意大利博洛尼亚
    5Unità广场Operativa Malattie Cardiovascolari，博洛尼亚大学，意大利博洛尼亚
    6Unità广场Operativa迪MicrobiologiaêVirologia，Azienda与Ospedaliero Universitaria博洛尼亚，位于Policlinico Sant'Orsola-马尔皮基，意大利博洛尼亚

* 联系人姓名：
彼得Andreone MD
Dipartimento迪Scienze MedicheêChirurgiche，UNIVERSITA阿布鲁Studi住宅博洛尼亚
通过Massarenti 9，40138意大利博洛尼亚
联系电话：00390512143618;传真：0039051345806
电子邮件：[email protected]

    这篇文章已被接受发表，并接受全面的同行评审，但经过审稿，排版，分页和校对过程中，这可能会导致这个版本和记录的版本之间的差异一直没有。请引用这篇文章的DOI：10.1111 / liv.13192


关键词：

    慢性乙型肝炎;小儿感染;维生素E;治疗

抽象
背景和目的

慢性乙型肝炎病毒感染的治疗儿童（CHB）仍存在很大不确定性的领域。维生素E是被证明是安全和有效的用于成人CHB的治疗的免疫刺激/抗氧化剂化合物。这一阶段2对照研究的目的是评估儿科HBeAg阳性慢性乙型肝炎治疗的安全性和维生素E的功效。
方法

四十六个儿童在1随机：1的比例以剂量15毫克/千克/天的（在盖伦制剂）或不处理为12个月接受维生素E和用于随后的12个月监测。临床，生化，血液学和血清病毒学评价进行了每3个月。
结果

无显著副作用与维生素E治疗有关。在研究结束时，在7/23（30.4％），得到抗HBe血清转换的维生素E处理的对照患者（p值= 0.05）与1/23（4.3％），而一个病毒学应答（≥在9/23（39.1％）与2/23（8.7％），分别为（p值= 0.035）观察从基线HBV-DNA）2日志减少。结论：在测试的剂量治疗小儿慢性乙型肝炎的维生素E给药没有显著的副作用，并可能诱发抗HBe血清学转换。维生素E可以表示为儿科慢性乙型肝炎的治疗的工具。

本文由版权保护。版权所有。