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一项在中国使用移动健康应用程序(Shield 01)对乙肝病毒母婴传播进行的真实世界前瞻性研究。

A Real-world Prospective Study of Mother-to-child Transmission of HBV in China Using a Mobile Health Application (Shield 01).

作者信息

Yin Xueru, Han Guorong, Zhang Hua, Wang Mei, Zhang Wenjun, Gao Yunfei, Zhong Mei, Wang Xiaolan, Zhong Xiaozhu, Shen Guojun, Yang Chuangguo, Liu Huiyuan, Liu Zhihong, Chan Po-Lin, Bulterys Marc, Cui Fuqiang, Zhuang Hui, Liu Zhihua, Hou Jinlin

机构信息

Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.

Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University, Nanjing, Jiangsu, China.

出版信息

J Clin Transl Hepatol. 2020 Mar 28;8(1):1-8. doi: 10.14218/JCTH.2019.00057. Epub 2020 Mar 5.

Abstract

The World Health Organization (WHO) Western Pacific Region set a target of eliminating mother-to-child transmission (MTCT) of hepatitis B virus (HBV) by 2030. To assess the feasibility of this target in China, we carried out an epidemiological study to investigate the status quo of MTCT in the real-world setting. One thousand and eight hepatitis B surface antigen-positive pregnant women were enrolled at 10 hospitals. Immunoprophylaxis was administered to infants. In addition, mothers with HBV DNA level >2,000,000 IU/mL were advised to initiate antiviral therapy during late pregnancy. A health application called SHIELD was used to manage the study. Nine hundred and five of the enrolled mothers, with 924 infants, completed the follow-up. Birth-dose hepatitis B vaccine and hepatitis B immunoglobulin were received by 99.7% and 99.7% of infants, respectively, within 24 h after birth. There were 446 mothers who received antiviral therapy, including 72.3% of the mothers with HBV DNA level >2,000,000 IU/mL and 21.0% of the mothers with HBV DNA level <2,000,000 IU/mL. Eight infants were infected with HBV. The overall rate of MTCT was 0.9%. Birth defects were rare (0.5% among infants with maternal antiviral exposure versus 0.7% among infants without exposure; =1.00). The MTCT rate was lower than the WHO Western Pacific Region elimination MTCT target in this real-world study, indicating that a comprehensive management composed of immunoprophylaxis to infants and antiviral prophylaxis to mothers may be a feasible strategy to achieve the 2030 WHO elimination goal.

摘要

世界卫生组织(WHO)西太平洋区域设定了到2030年消除乙型肝炎病毒(HBV)母婴传播(MTCT)的目标。为评估这一目标在中国的可行性,我们开展了一项流行病学研究,以调查实际环境中MTCT的现状。在10家医院招募了1008名乙型肝炎表面抗原阳性孕妇。对婴儿进行了免疫预防。此外,建议HBV DNA水平>2000000 IU/mL的母亲在妊娠晚期开始抗病毒治疗。使用一款名为SHIELD的健康应用程序来管理该研究。905名登记母亲及其924名婴儿完成了随访。分别有99.7%的婴儿在出生后24小时内接种了首剂乙肝疫苗和乙肝免疫球蛋白。446名母亲接受了抗病毒治疗,其中HBV DNA水平>2000000 IU/mL的母亲占72.3%,HBV DNA水平<2000000 IU/mL的母亲占21.0%。8名婴儿感染了HBV。MTCT的总体发生率为0.9%。出生缺陷很少见(母亲接受抗病毒治疗的婴儿中为0.5%,未接受治疗的婴儿中为0.7%;P = 1.00)。在这项实际研究中,MTCT发生率低于WHO西太平洋区域消除MTCT的目标,这表明由婴儿免疫预防和母亲抗病毒预防组成的综合管理可能是实现WHO 2030年消除目标的可行策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adc8/7132014/1d9a04460daf/JCTH-8-001-g001.jpg

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