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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

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.

作者信息

Li Wenhui, Jia Li, Zhao Xin, Wu Xiaoyuan, Tang Hongxia

机构信息

Department of Infectious Disease, Children's Hospital of Hebei Province, 133 South Jianhua Street, Shijiazhuang, 050031, Hebei, China.

Department of Neurology, Children's Hospital of Hebei Province, 133 South Jianhua Street, Shijiazhuang, 050031, Hebei, China.

出版信息

BMC Gastroenterol. 2018 Aug 2;18(1):121. doi: 10.1186/s12876-018-0847-2.

Abstract

BACKGROUND

The vertical transmission of HBV from mothers to their infants at birth or in early infancy has a significant role in the endemicity of HBV infection. Tenofovir is one of the most potent anti-HBV agents with a high genetic barrier to resistance. The study is to evaluate the efficacy of tenofovir in preventing perinatal HBV transmission, as well as monitoring safety for mothers and infants.

METHODS

PubMed, Embase, Web of Science, and CNKI (National Knowledge Infrastructure, China) database were systematically reviewed for studies that compared the efficacy and safety of tenofovir with other treatments. Pooled estimates were expressed with weight mean difference (WMD) with 95% confidence intervals (95% CIs) and risk ratio (RR) with 95% CIs.

RESULTS

Nine studies involving 1046 pregnant patients met the inclusion criteria and were included in this meta-analysis. Compared with other treatments, tenofovir significantly reduced maternal HBV DNA levels (WMD = 2.33 log IU/mL, 95% CI: 1.01, 3.64; P < 0.001), infant HBsAg positivity rate (RR = 0.25, 95% CI: 0.16, 0.38; P < 0.001), infant HBeAg positivity rate (RR = 0.26, 95% CI: 0.14, 0.48; P < 0.001), infant HBV DNA positivity rate (RR = 0.15, 95% CI: 0.07, 0.31; P < 0.001), and immunoprophylaxis failure rate (RR = 0.31, 95% CI: 0.13, 0.73; P = 0.008). Moreover, maternal and infant safety profiles, including ALT, CK, and Cr were comparable between tenofovir and other treatment groups.

CONCLUSION

Based on the current evidence, our study suggested that tenofovir significantly reduced the rate of vertical transmission of HBV, as well as the HBV DNA levels in HBV-infected mothers. Moreover, tenofovir was safe and tolerable for both mothers and their infants.

摘要

背景

乙肝病毒(HBV)在出生时或婴儿早期由母亲垂直传播给婴儿,在HBV感染的地方性流行中起重要作用。替诺福韦是最有效的抗HBV药物之一,对耐药具有较高的基因屏障。本研究旨在评估替诺福韦预防围产期HBV传播的疗效,以及监测其对母婴的安全性。

方法

系统检索PubMed、Embase、Web of Science和中国知网(CNKI)数据库,查找比较替诺福韦与其他治疗方法疗效和安全性的研究。合并估计值用加权均数差(WMD)及95%置信区间(95%CI)和风险比(RR)及95%CI表示。

结果

9项涉及1046例孕妇的研究符合纳入标准,被纳入本荟萃分析。与其他治疗方法相比,替诺福韦显著降低了母亲的HBV DNA水平(WMD = 2.33 log IU/mL,95%CI:1.01,3.64;P < 0.001)、婴儿HBsAg阳性率(RR = 0.25,95%CI:0.16,0.38;P < 0.001)、婴儿HBeAg阳性率(RR = 0.26,95%CI:0.14,0.48;P < 0.001)、婴儿HBV DNA阳性率(RR = 0.15,95%CI:0.07,0.31;P < 0.001)和免疫预防失败率(RR = 0.31,95%CI:0.13,0.73;P = 0.008)。此外,替诺福韦组与其他治疗组之间的母婴安全性指标,包括ALT、CK和Cr相当。

结论

基于目前的证据,我们的研究表明,替诺福韦显著降低了HBV的垂直传播率以及HBV感染母亲的HBV DNA水平。此外,替诺福韦对母亲及其婴儿安全且耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ea4/6090972/de75c1d1e5db/12876_2018_847_Fig1_HTML.jpg

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