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替诺福韦用于孕期预防高病毒血症女性乙肝垂直传播的前瞻性干预研究。

Prospective interventional study of tenofovir in pregnancy to prevent vertical transmission of hepatitis B in highly viremic women.

作者信息

Sellier Pierre O, Maylin Sarah, Berçot Béatrice, Chopin Dorothée, Lopes Amanda, Simoneau Guy, Evans John, Delcey Véronique, Bénifla Jean-Louis, Simon François, Bergmann Jean-François

机构信息

aInternal Medicine Department bMicrobiology Department cObstetrics Department, Saint-Louis/Lariboisiere-Fernand Widal Hospital, Paris, France.

出版信息

Eur J Gastroenterol Hepatol. 2017 Mar;29(3):259-263. doi: 10.1097/MEG.0000000000000793.

DOI:10.1097/MEG.0000000000000793
PMID:27879486
Abstract

BACKGROUND

The risk of vertical transmission of hepatitis B virus (HBV) increases as maternal HBV DNA increase, despite serovaccination to newborns.

METHODS

From 1 July 2012 to 1 January 2016, all pregnant women in Lariboisiere Hospital, Paris, France, with HBV DNA of 5 log10 IU/ml and above were administered tenofovir from week 28 of pregnancy until delivery. HBV DNA was measured at months 1, 2 of tenofovir and at delivery. The newborns were serovaccinated, tested for hepatitis B surface antigen, hepatitis B core antibody (HBcAb)±HBV DNA, and hepatitis B surface antibody (HBsAb) when aged 9 months, and then 24 months. This study was registered in http://www.ClinicalTrials.gov (NCT02039362).

RESULTS

Thirty-one women gave birth to 37 newborns. Maternal HBV DNA at baseline was 8.23 log10 IU/ml and above in 12 pregnancies. The mean (median) HBV DNA were 4.4±1.2 (4.8), 3.3±1.7 (3.8), and 2.1±1.9 (2.0) log10 IU/ml at months 1, 2 of tenofovir and at delivery, respectively. Twenty-seven newborns were followed up: none of the 19 children aged 9 months or older was positive for hepatitis B surface antigen when aged 9 months; 14 children tested positive for HBcAb (probably transferred maternal antibodies, not found when aged 24 months) and for HBsAb without HBV DNA. Four of the 19 children showed HBsAb without HBcAb, the last being doubtful for HBcAb and HBsAb without HBV DNA. Eight newborns aged less than 9 months were not tested.

CONCLUSION

Tenofovir from week 28 of pregnancy to highly viremic HBV women plus serovaccination to newborns could prevent chronic and past infection.

摘要

背景

尽管对新生儿进行了血清疫苗接种,但随着母亲乙肝病毒(HBV)DNA水平的升高,HBV垂直传播的风险也会增加。

方法

2012年7月1日至2016年1月1日,法国巴黎拉里博瓦西埃医院所有HBV DNA达到5 log10 IU/ml及以上的孕妇,从妊娠第28周开始至分娩期间接受替诺福韦治疗。在服用替诺福韦1个月、2个月时以及分娩时检测HBV DNA。新生儿进行血清疫苗接种,在9个月龄时检测乙肝表面抗原、乙肝核心抗体(HBcAb)±HBV DNA以及乙肝表面抗体(HBsAb),然后在24个月龄时再次检测。本研究已在http://www.ClinicalTrials.gov注册(NCT02039362)。

结果

31名女性分娩了37名新生儿。12例妊娠中,基线时母亲的HBV DNA为8.23 log10 IU/ml及以上。服用替诺福韦1个月、2个月时以及分娩时,HBV DNA的平均(中位数)水平分别为4.4±1.2(4.8)、3.3±1.7(3.8)和2.1±1.9(2.0)log10 IU/ml。对27名新生儿进行了随访:19名9个月龄及以上儿童在9个月龄时乙肝表面抗原均为阴性;14名儿童HBcAb检测呈阳性(可能是母传抗体,在24个月龄时未检测到),且HBsAb呈阳性但无HBV DNA。19名儿童中有4名仅显示HBsAb阳性而无HBcAb,最后一名儿童HBcAb和HBsAb检测结果存疑且无HBV DNA。8名年龄小于9个月的新生儿未进行检测。

结论

对高病毒血症的HBV感染女性,从妊娠第28周开始使用替诺福韦并对新生儿进行血清疫苗接种,可预防慢性感染和既往感染。

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Efficacy and safety of tenofovir in preventing mother-to-infant transmission of hepatitis B virus: a meta-analysis based on 6 studies from China and 3 studies from other countries.替诺福韦预防乙型肝炎病毒母婴传播的疗效与安全性:一项基于6项中国研究和3项其他国家研究的荟萃分析
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