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系统评价与荟萃分析:替诺福韦预防乙型肝炎病毒母婴传播的疗效和安全性。

Systematic review with meta-analysis: the efficacy and safety of tenofovir to prevent mother-to-child transmission of hepatitis B virus.

机构信息

Department of Internal Medicine, Korea University Medical Center, Seoul, Korea.

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea.

出版信息

Aliment Pharmacol Ther. 2017 Jun;45(12):1493-1505. doi: 10.1111/apt.14068. Epub 2017 Apr 24.

DOI:10.1111/apt.14068
PMID:28436552
Abstract

BACKGROUND

Preventing mother to child transmission of chronic hepatitis B infection in the setting of a high maternal viral load is challenging. The idea has emerged from antepartum tenofovir treatment with combination immunoprophylaxis.

AIMS

To demonstrate the efficacy and safety of tenofovir to prevent mother to child transmission of hepatitis B virus.

METHODS

PubMed, EMBASE, and Cochrane databases were searched through August 16, 2016. Comparative trials of second or third trimester tenofovir administration vs. controls for patients with chronic hepatitis B infection and non-comparative case series assessing mother to child transmission rates and evaluating maternal and foetal safety outcomes were included.

RESULTS

Ten studies (one randomised controlled trial, four non-randomised controlled trials and five case series) that enrolled 733 women were included. The pooled results from comparative trials (599 pregnancies) showed that tenofovir significantly reduced the risk of infant hepatitis B surface antigen seropositivity by 77% (odds ratio=0.23, 95% confidence intervals=0.10-0.52, P=.0004) without heterogeneity (I =0%). In the case series analysis (134 pregnancies), only two cases (1.5%) of mother to child transmission with extremely high maternal viral load and non-compliance to treatment were identified. Maternal and foetal safety parameters including congenital malformation and foetal death were re-assuring.

CONCLUSIONS

For pregnant women with high hepatitis B virus DNA levels, tenofovir administration in the second or third trimester can prevent mother to child transmission when combined with hepatitis B immunoglobulin and the hepatitis B vaccine. Tenofovir is safe and tolerable for both the mother and foetus.

摘要

背景

在母体病毒载量高的情况下,预防慢性乙型肝炎母婴传播具有挑战性。这种想法源于产前替诺福韦联合免疫预防。

目的

证明替诺福韦预防乙型肝炎病毒母婴传播的疗效和安全性。

方法

通过 2016 年 8 月 16 日检索 PubMed、EMBASE 和 Cochrane 数据库。纳入了比较研究,即在第二或第三孕期给予替诺福韦与对照组比较,评估慢性乙型肝炎感染患者;以及评估母婴传播率和评估母婴安全性结局的非比较病例系列。

结果

共纳入 10 项研究(1 项随机对照试验、4 项非随机对照试验和 5 项病例系列),共纳入 733 例女性。来自比较试验的汇总结果(599 例妊娠)显示,替诺福韦可显著降低婴儿乙型肝炎表面抗原阳性的风险,降幅为 77%(比值比=0.23,95%置信区间=0.10-0.52,P=0.0004),无异质性(I =0%)。在病例系列分析(134 例妊娠)中,仅发现 2 例(1.5%)母婴传播,这两例患者的母亲病毒载量极高且不遵医嘱。包括先天性畸形和胎儿死亡在内的母婴安全参数令人放心。

结论

对于乙型肝炎病毒 DNA 水平较高的孕妇,在第二或第三孕期给予替诺福韦,联合乙型肝炎免疫球蛋白和乙型肝炎疫苗,可以预防母婴传播。替诺福韦对母亲和胎儿均安全且耐受良好。

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