Eunice Kennedy Shriver National Institute for Child Health and Human Development, Bethesda, MD, USA.
J Perinat Med. 2011 Mar;39(2):163-70. doi: 10.1515/jpm.2010.139. Epub 2010 Dec 13.
To determine rate of and risk factors for birth defects in infants born to HIV-infected women receiving nucleoside and protease inhibitor antiretroviral (ARV) therapy.
Birth defects were evaluated among infants on the Pediatric AIDS Clinical Trials Group 316 trial that studied addition of peripartum nevirapine to established ARV regimen for prevention of mother-to-child transmission. Maternal therapy was categorized by trimester of earliest exposure. Birth defects were coded using conventions of the Antiretroviral Pregnancy Registry.
Birth defects were detected in 60/1414 (4.2%; 95% CI 3.3-5.4%) infants including 30/636 (4.7%; 95% CI 3.2-6.7%) with first trimester ARV exposure and 30/778 (3.9%; 95% CI 2.6-5.5%) with exposure only after the first trimester (P=0.51). Rates of classes of defects were similar between first trimester compared to later exposure groups except heart defects which occurred in 16 (2.5%; 95% CI 1.4-4.1%) with first trimester ARV exposure and in six (0.8%; 95% CI 0.3-1.7%) infants with later exposure (P=0.02). Exposure to ARV was not associated with specific types of heart defects. Two cases of cardiomyopathy were noted.
ARV use in early pregnancy was not associated with an increased risk of birth defects overall. The possible association of ARV exposure with heart defects requires further surveillance.
确定接受核苷类和蛋白酶抑制剂抗逆转录病毒（ARV）治疗的 HIV 感染妇女所生婴儿的出生缺陷发生率和危险因素。
在儿科艾滋病临床试验组 316 试验中评估了婴儿的出生缺陷，该试验研究了在已建立的 ARV 方案中添加围产期奈韦拉平，以预防母婴传播。将母体治疗按最早暴露的妊娠三季分类。出生缺陷使用抗逆转录病毒妊娠登记处的约定进行编码。
在 1414 名婴儿中发现了 60 例（4.2%；95%CI 3.3-5.4%）出生缺陷，其中 30 例（4.7%；95%CI 3.2-6.7%）在妊娠早期接受 ARV 暴露，30 例（3.9%；95%CI 2.6-5.5%）仅在妊娠第一季度后暴露（P=0.51）。在妊娠早期暴露组与后期暴露组之间，各缺陷类别的发生率相似，除了心脏缺陷，在妊娠早期 ARV 暴露的婴儿中有 16 例（2.5%；95%CI 1.4-4.1%），在后期暴露的婴儿中有 6 例（0.8%；95%CI 0.3-1.7%）（P=0.02）。ARV 暴露与特定类型的心脏缺陷无关。注意到 2 例心肌病。
妊娠早期使用 ARV 与出生缺陷总体风险增加无关。ARV 暴露与心脏缺陷的可能关联需要进一步监测。
