White A, Eldridge R, Andrews E
Worldwide Epidemiology Department, Glaxo Wellcome Inc., Research Triangle Park, NC 27709, USA.
Acta Paediatr Suppl. 1997 Jun;421:86-8. doi: 10.1111/j.1651-2227.1997.tb18327.x.
Potential risk of adverse birth outcomes associated with the use of antiretrovirals in human immunodeficiency virus (HIV)-infected women during pregnancy must be assessed. Data through June 1995 are reported from the worldwide Antiretroviral Pregnancy Registry on the incidence of structural birth defects following prenatal exposure to zidovudine. Healthcare professionals register pregnant women anonymously. Follow-up is at time of delivery. Results are reviewed semi-annually by an advisory committee, which follows the Centers for Disease Control and Prevention (CDC) guidelines for definitions of birth defects. From 1989 through to 30 June, 1995, 198 outcomes involving exposure to zidovudine were reported. Of 73 first-trimester exposures, outcomes included one infant with a birth defect. Of 125 exposures in the second and third trimesters, six infants were reported with birth defects. Data on other antiretrovirals are insufficient for analysis. The Registry findings to date do not show an increase in the number of birth defects (1/63 in the first trimester, or 1.59%, 95% CI 0.083%, 9.69%) following prenatal zidovudine exposure when compared with that expected in the general population; however, the number of outcomes to date represents a sample of insufficient size for developing precise estimates regarding the teratogenic risk of zidovudine.
必须评估人类免疫缺陷病毒（HIV）感染女性在孕期使用抗逆转录病毒药物与不良分娩结局相关的潜在风险。全球抗逆转录病毒药物妊娠登记处报告了截至1995年6月的关于产前暴露于齐多夫定后结构性出生缺陷发生率的数据。医疗保健专业人员对孕妇进行匿名登记。随访在分娩时进行。咨询委员会每半年对结果进行审查，该委员会遵循疾病控制与预防中心（CDC）关于出生缺陷定义的指南。从1989年到1995年6月30日，报告了198例涉及暴露于齐多夫定的结局。在73例孕早期暴露中，结局包括1例有出生缺陷的婴儿。在125例孕中期和孕晚期暴露中，报告有6例婴儿有出生缺陷。关于其他抗逆转录病毒药物的数据不足以进行分析。登记处目前的研究结果并未显示产前暴露于齐多夫定后出生缺陷数量增加（孕早期为1/63，即1.59%，95%可信区间为0.083%，9.69%），与一般人群预期的相比；然而，目前的结局数量代表的样本规模不足以就齐多夫定的致畸风险得出精确估计。
