富马酸丙酚替诺福韦与替诺福韦二吡呋酯阻断HBV母婴传播有效性和安全性研究*

doi:10.3969/j.issn.1672-5069.2025.02.006

实用肝脏病杂志 ›› 2025, Vol. 28 ›› Issue (2): 182-185.doi: 10.3969/j.issn.1672-5069.2025.02.006

富马酸丙酚替诺福韦与替诺福韦二吡呋酯阻断HBV母婴传播有效性和安全性研究^*

熊霞鹂, 周鑫, 朱云霞, 魏宏, 赵志强, 李华, 邹怀宾, 段钟平

100069 北京市首都医科大学附属北京佑安医院产科(熊霞鹂,周鑫,朱云霞,魏宏,赵志强);肝病内科(邹怀宾,段钟平);附属北京朝阳医院妇产科(熊霞鹂,李华)

收稿日期:2024-04-07 出版日期:2025-03-10 发布日期:2025-03-11
通讯作者: 段钟平,E-mail: duan@ccmu.edu.cn
作者简介:熊霞鹂,女,38岁,博士研究生,副主任医师。主要从事妊娠合并肝病的诊断与治疗学研究。E-mail:xiongxiali2009@163.com
基金资助:
^*国家科技重大专项“艾滋病和病毒性肝炎等重大传染病防治”基金资助项目(编号:2017ZX10201201-001-001/2017ZX10201201-002-002/2017ZX10201201-002-009);北京市属医院科研培育计划项目(编号:PX2020067);北京市丰台区卫生健康系统科研项目(编号:2023-66);北京佑安医院院长基金资助课题(编号:2020-114)

Comparison of tenofovir alafenamide fumarate and tenofovir disoproxil fumarate in terminating mother to child transmission of hepatitis B viral infection

Xiong Xiali, Zhou Xin, Zhu Yunxia, et al

Department of Obstetrics and Liver Diseases, You'an Hospital;Department of Obstetrics and Gynecology, Beijing Chaoyang Hospital,Affiliated to Capital Medical University, Beijing 100069, China

Received:2024-04-07 Online:2025-03-10 Published:2025-03-11

摘要/Abstract

摘要： 目的评估HBV感染孕妇在孕期接受核苷酸类抗病毒治疗阻断母婴传播的有效性和安全性。方法 2021年7月～2022年8月首都医科大学附属北京佑安医院诊治的112例HBeAg阳性HBV携带孕妇,于孕26～28周开始口服富马酸丙酚替诺福韦(TAF,n=57)或替诺福韦二吡呋酯(TDF,n=55)阻断治疗,至分娩后停用。常规给予新生儿预防接种,记录孕妇妊娠并发症,于新生儿出生后7～9月龄时检测血清HBV标记物和HBV DNA载量。结果分娩前,TAF阻断组早产、妊娠期肝内胆汁淤积症(ICP)、妊娠期高血压病(HDCP)、胎膜早破(PROM)、羊水少和羊水过少发生率分别为7.0%、8.8%、7.0%、12.3%、7.0%和3.5%,与TDF阻断组的5.5%、9.1%、5.5%、10.9%、3.6%和0.0%比,差异无统计学意义(均P>0.05);TAF组血清ALP水平为(146.1±44.3)U/L,显著低于TDF组【(166.9±52.5)U/L,P＜0.05】;TAF组尿蛋白(uPRO)阳性率为7.0%,显著低于TDF组的23.6%(P＜0.05);两组血清ALT、AST、TBIL、sCr、P、Ca和肾小球滤过率(GFR)比较,差异无统计学意义(P>0.05);TAF组血清HBV DNA载量为(3.4±0.7)lg IU/ml,显著高于TDF组【(2.9±0.8)lg IU/ml,P＜0.05】;两组新生儿均未发生母婴传播。结论对于HBeAg阳性HBV携带孕妇,在孕期应用TAF行抗病毒阻断治疗,阻断效果好,对肾功能的影响更小。

关键词: 乙型肝炎病毒携带者, 富马酸丙酚替诺福韦, 孕妇, 胎儿, 肾毒性, 母婴传播

Abstract: Objective The aim of this study was to compare efficacy and safety of tenofovir alafenamide fumarate (TAF) and tenofovir disoproxil fumarate (TDF) in terminating mother to child transmission (MTCT) of hepatitis B viral infection. Methods 112 pregnant hepatitis B virus carriers with serum HBeAg positive were encountered in Beijing You'an Hospital, Capital Medical University between July 2021 and August 2022, and all received TAF (n=57) or TDF (n=55) antiviral therapy for blocking viral transmission, which discontinued before giving birth. All infants received standardized immune inoculation and were evaluated for serum HBV markers and HBV DNA loads at seven to nine month ages. Results Before delivery, incidence rates of premature birth, intrahepatic cholestasis of pregnancy, hypertensive disorder complicating pregnancy, premature rupture of membranes, slightly less amniotic fluid and oligohydramnios in the TAF-treated group were 7.0%, 8.8%, 7.0%, 12.3%, 7.0% and 3.5%, all not much different compared to 5.5%, 9.1%, 5.5%, 10.9%, 3.6% and 0.0% in TDF-treated group (all P>0.05); serum ALP level in TAF group was (146.1±44.3)U/L, much lower than [(166.9±52.5)U/L, P＜0.05] in TDF group; urine protein positive rate in TAF group was 7.0%, much lower than 23.6%(P＜0.05) in TDF group; there were no significant differences as respect to serum ALT, AST, bilirubin, serum creatinine, phosphorus, calcium and glomerular filtration rates in the two groups (P>0.05); serum HBV DNA load in the TAF group was (3.4±0.7)lg IU/ml, much higher than [(2.9±0.8)lg IU/ml, P＜0.05] in TDF group; no MTCT occurred in the two group. Conclusion Antiviral therapy with TAF during pregnancy could efficaciously block MTCT of HBV infection in pregnant women with chronic HBV carriers, with higher renal safety.

Key words: Hepatitis B viral carriers, Tenofovir alafenamide fumarate, Pregnancy, Fetus, Renal toxicity, Maternal to child transmission

熊霞鹂, 周鑫, 朱云霞, 魏宏, 赵志强, 李华, 邹怀宾, 段钟平. 富马酸丙酚替诺福韦与替诺福韦二吡呋酯阻断HBV母婴传播有效性和安全性研究^*[J]. 实用肝脏病杂志, 2025, 28(2): 182-185.

Xiong Xiali, Zhou Xin, Zhu Yunxia, et al. Comparison of tenofovir alafenamide fumarate and tenofovir disoproxil fumarate in terminating mother to child transmission of hepatitis B viral infection[J]. Journal of Practical Hepatology, 2025, 28(2): 182-185.

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富马酸丙酚替诺福韦与替诺福韦二吡呋酯阻断HBV母婴传播有效性和安全性研究^*

Comparison of tenofovir alafenamide fumarate and tenofovir disoproxil fumarate in terminating mother to child transmission of hepatitis B viral infection

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