长期安全性和功效的替比夫定在婴儿出生的母亲在怀孕的第

StephenW

J Viral Hepat. 2016 Dec 31. doi: 10.1111/jvh.12670. [Epub ahead of print]
Long-term safety and efficacy of telbivudine in infants born to mothers treated during the second or third trimesters of pregnancy.Han GR1, Jiang HX1, Wang CM1, Ding Y1, Wang GJ1, Yue X1, Zhou L2, Zhao W3.
Author information

• 1Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University, Nanjing, China.
• 2Department of Gynecology and Obstetrics, School of Medicine, Southeast University, Nanjing, China.
• 3Department of Infectious Diseases, The Second Affiliated Hospital of the Southeast University, Nanjing, China.
  

AbstractTelbivudine, an FDA pregnancy category B drug, has been found to reduce hepatitis B virus (HBV) perinatal transmission with no safety concerns in infants aged up to 1 year. This study evaluated the long-term efficacy and safety of telbivudine in 214 infants born to 210 pregnant women with chronic hepatitis B infection who were treated with telbivudine during pregnancy (weeks 20-32 of gestation). The infants were followed for up to 5 years after birth. The efficacy endpoint was the rate of perinatal transmission, which was established by HBsAg and HBV DNA levels at 7 and 12 months. Safety endpoints included head circumference, weight, height, and congenital abnormality and hospitalization rates. In addition, the Denver Developmental Screening Test was performed in 92 randomly selected infants. None of the 214 infants born to these women were infected with HBV, and all had effective serum hepatitis B surface antibody (HBsAb) levels. Compared with Chinese standard values, there were few differences in the infants' mean head circumference, weight, and height values. No birth defects were diagnosed, and the congenital abnormality rate was 0.934%. Serious adverse events requiring hospitalization occurred in 20 infants (9.35%). The qualified Denver Developmental Screening Test rate in 92 infants was 97.82%, which was comparable to a rate of 92% in normal Chinese children. Thus, treatment with telbivudine during the second or third trimesters of pregnancy safely blocked perinatal transmission of HBV. Infants born to telbivudine-treated mothers showed normal growth and development during long-term follow-up of up to 5 years. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

KEYWORDS: Denver Developmental Screening Test; chronic hepatitis B; hepatitis B virus; mother-to-child transmission; perinatal transmission

PMID:28039902DOI:10.1111/jvh.12670

StephenW

J病毒Hepat。 2016 12月31日。doi：10.1111 / jvh.12670。 [打印前的电子版]
长期安全性和功效的替比夫定在婴儿出生的母亲在怀孕的第二个或第三个三个月期间治疗。
Han GR1，Jiang HX1，Wang CM1，Ding Y1，Wang GJ1，Yue X1，Zhou L2，Zhao W3。
作者信息

    1.东南大学第二附属医院妇产科，南京。
    2东南大学医学院妇产科，南京。
    东南大学第二附属医院传染病研究室，南京。

抽象

已经发现替比夫定（一种FDA怀孕B类药物）可以减少乙型肝炎病毒（HBV）围产期传播，对于1岁以下的婴儿没有安全问题。本研究评估了长期效力和安全性的替比夫定在214名婴儿出生的210名怀孕妇女慢性乙型肝炎感染谁在怀孕期间（怀孕20-32周）治疗telbivudine。婴儿出生后随访5年。疗效终点是围产期传播的速率，其由HBsAg和HBV DNA水平在7个月和12个月建立。安全终点包括头围，体重，身高，先天性异常和住院率。此外，丹佛发育筛选试验在92个随机选择的婴儿中进行。这些妇女出生的214名婴儿中没有一人感染HBV，并且都具有有效的血清乙型肝炎表面抗体（HBsAb）水平。与中国标准值相比，婴儿的平均头围，体重和身高值差异不大。没有诊断出生缺陷，先天性异常率为0.934％。在20名婴儿中发生需要住院治疗的严重不良事件（9.35％）。 92个婴儿的合格丹佛发育筛查试验率为97.82％，与正常中国儿童的92％相当。因此，在怀孕的第二或第三个三个月期间用替比夫定治疗安全地阻断了围产期HBV的传播。替比夫定治疗的母亲出生的婴儿在长达5年的长期随访期间显示正常的生长和发育。本文受版权保护。版权所有。

本文受版权保护。版权所有。
关键词：

丹佛发展筛选试验;慢性乙型肝炎;乙型肝炎病毒;母婴传播;围产期传播

PMID：
    28039902
DOI：
    10.1111 / jvh.12670