Proximal tubular dysfunction in pregnant women receiving tenofovir disoproxil fumarate to prevent mother-to-child transmission of hepatitis B virus.
Proximal tubular dysfunction in pregnant women receiving tenofovir disoproxil fumarate to prevent mother-to-child transmission of hepatitis B virus.
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接受富马酸替诺福韦酯预防乙型肝炎病毒母婴传播的孕妇的近端肾小管功能障碍。
DOI：
10.1093/jac/dkab490
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发表时间：
2022
期刊：
影响因子：
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通讯作者：
YvesMary,Jea
中科院分区：
文献类型：
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作者：
Liegeon,Geoffroy;Ngo-Giang-Huong,Nicole;Salvadori,Nicolas;Bunpo,Piyawan;Cressey,Ratchada;Achalapong,Jullapong;Kanjanavikai,Prateep;PatamasinghNaAyudhaya,Orada;Prommas,Sinart;Siriwachirachai,Thitiporn;Sabsanong,Prapan;YvesMary,Jea
背景资料评价的风险近端肾小管功能障碍的妇女接受替诺福韦二异戊醇富马酸盐预防母婴传播（PMTCT）的HBV是稀缺的。一项双盲、安慰剂对照的临床试验，在泰国评估从孕龄28周（28-wk-GA）至产后2个月（2-month-PP）的富马酸替诺福韦酯短程治疗HBV的PMTCT。在28周和32周GA和2个月PP访视时测定肾小管功能障碍标志物，包括视黄醇结合蛋白、肾损伤分子-1、α1-微球蛋白和β2-微球蛋白。近端肾小管病变的定义为存在≥2以下：肾小管蛋白尿，正常血糖糖尿和尿磷酸盐增加。ResultsA共291名妇女参加了这项研究。没有严重的肾脏相关不良事件，也没有导致富马酸替诺福韦酯停药。在2个月PP时，富马酸替诺福韦酯组120名评估女性中有3名（3%）发生近端肾小管病变，而安慰剂组125名中有3名（2%）发生近端肾小管病变（P= 1.00）。在12个月PP时，6名女性中没有一名符合近端小管病变的标准，但其中3名患者持续存在蛋白尿。未发现生长异常，在1岁的婴儿出生的母亲与近端肾小管病变在2个月-PP。ConclusionsIn这些HBV感染的孕妇和哺乳期妇女，替诺福韦酯富马酸盐管理从28周-GA至2个月-PP与近端肾小管病变的风险较高。
BackgroundData evaluating the risk of proximal tubular dysfunction in women receiving tenofovir disoproxil fumarate for the prevention of mother-to-child transmission (PMTCT) of HBV are scarce.ObjectivesTo assess the risk of proximal tubulopathy in pregnant women receiving tenofovir disoproxil fumarate for PMTCT of HBV.Patients and methodsWe used urine samples collected from HBV monoinfected pregnant women who participated in a Phase III, multicentre, randomized, double-blind, placebo-controlled clinical trial assessing a tenofovir disoproxil fumarate short course from 28 weeks gestational age (28-wk-GA) to 2 months post-partum (2-months-PP) for PMTCT of HBV in Thailand. Markers of tubular dysfunction, including retinol binding protein, kidney injury molecule-1, α1-microglobuin and β2-microglobulin, were assayed at 28- and 32-wk-GA and 2-months-PP visits. Proximal tubulopathy was defined as the presence of ≥2 of the following: tubular proteinuria, euglycaemic glycosuria and increased urinary phosphate.ResultsA total of 291 women participated in the study. No kidney-related adverse events were severe, and none led to tenofovir disoproxil fumarate discontinuation. At 2-months-PP, 3 of the 120 (3%) evaluated women in the tenofovir disoproxil fumarate group experienced proximal tubulopathy versus 3 of 125 (2%) in the placebo group (P= 1.00). None of the six women met the criteria for proximal tubulopathy at 12-months-PP but proteinuria persisted in three of them. No growth abnormalities were found at 1 year of age in infants born to mothers with proximal tubulopathy at 2-months-PP.ConclusionsIn these HBV-infected pregnant and breastfeeding women, tenofovir disoproxil fumarate administered from 28-wk-GA to 2-months-PP was not associated with a higher risk of proximal tubulopathy.