NEJM:替诺福韦可预防高病毒载量孕妇乙型肝炎传播

2016-06-17 Seven L 译 MedSci原创

目前关于孕期使用替诺福韦酯(TDF)预防乙型肝炎病毒(HBV)母婴传播的数据几乎没有。因此有研究者对200名乙型肝炎病毒e抗原(HBeAg)阳性和HBV DNA水平高于200,000 IU/ml的孕妇进行了一项研究。参与者按1:1随机分为接受常规的无抗病毒治疗的护理或TDF(每天口服300 mg),从妊娠32-34周直到产后4周。对参与者随访直产后28周。所有的婴儿接受免疫预防。主要结果是母婴传播

目前关于孕期使用替诺福韦酯(TDF)预防乙型肝炎病毒(HBV)母婴传播的数据几乎没有。

因此有研究者对200名乙型肝炎病毒e抗原(HBeAg)阳性和HBV DNA水平高于200,000 IU/ml的孕妇进行了一项研究。参与者按1:1随机分为接受常规的无抗病毒治疗的护理或TDF(每天口服300 mg),从妊娠32-34周直到产后4周。对参与者随访直产后28周。所有的婴儿接受免疫预防。主要结果是母婴传播和出生缺陷的发生率。次要终点为TDF的安全、分娩时HBV DNA水平低于200,000 IU/ml的比例、产后28周HBeAg转阴或乙型肝炎表面抗原血清转换。

数据显示,分娩时HBV DNA水平低于200,000 IU/ml的比例在TDF组和对照组分别为68%(66/97)和2%(2/100)。产后28周,TDF组的母婴传播率显著低于对照组(ITT分析:5% [5/97] vs. 18% [18/100], P=0.007;PP分析:0 vs. 7% [6/88], P=0.01 )。TDF组的母婴安全性与对照组相似,包括出生缺陷(2% [2/95] and 1% [1/88]; P=1.00),不过TDF组母亲的肌酸激酶水平增加的比例更高。停止TDF药物后,TDF组母亲谷丙转氨酶升高超过正常范围的比例更高(45% [44/97] vs. 30% [30/100], P=0.03)。孕产妇HBV血清学结果在组间没有明显差异。

研究结果表明,对孕晚期HBeAg阳性和HBV DNA水平超过200,000 IU/ml的孕妇使用TDF治疗,可显著降低HBV的母婴传播率。

原始出处:

Calvin Q. Pan, Zhongping Duan,et al.Tenofovir to Prevent Hepatitis B Transmission in Mothers with High Viral Load.N Engl J Med 2016; 374:2324-2334June 16, 2016DOI: 10.1056/NEJMoa1508660


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    2016-06-30 吴教授

    一篇不错的文章。

    0

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    2016-06-18 沉心多思

    好文章,值得学习

    0

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    2016-06-17 xyfg98

    要这么做

    0

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