MMWR Recomm Rep. 1994 Aug 5;43(RR-11):1-20.
These recommendations update the interim guidelines (1) developed by the U.S. Public Health Service for the use of zidovudine (ZDV) to reduce the risk for perinatal transmission of human immunodeficiency virus (HIV) infection. The recently reported results of AIDS Clinical Trials Group Protocol 076 demonstrated that ZDV administered to a selected group of HIV-infected pregnant women and their infants can reduce the risk for perinatal HIV transmission by approximately two-thirds. The regimen used in this trial included antenatal oral administration of ZDV beginning at 14-34 weeks of gestation and continuing throughout pregnancy, followed by intrapartum intravenous ZDV and postnatal oral administration of ZDV to the infant for 6 weeks after delivery. This document summarizes the results of the trial, discusses limitations in the interpretation of the results, reviews the potential long-term adverse effects of this ZDV regimen for infants and women, and provides recommendations for the use of ZDV to reduce perinatal transmission and for medical monitoring of pregnant women and infants receiving this therapy. Because the clinical status of many HIV-infected women may differ from that of the women in this trial, the recommendations should be tailored to each woman's clinical situation. The potential benefits, unknown long-term effects, and gaps in knowledge about her specific clinical situation must be discussed with the woman. This information is intended to provide a basis for discussion between the woman and her healthcare provider so that the woman can weigh the risks and benefits of such therapy and make informed decisions about her treatment.
这些建议更新了美国公共卫生服务部制定的关于使用齐多夫定(ZDV)以降低人类免疫缺陷病毒(HIV)感染围产期传播风险的临时指南。艾滋病临床试验组方案076最近报告的结果表明,对一组选定的感染HIV的孕妇及其婴儿给予ZDV可将围产期HIV传播风险降低约三分之二。该试验中使用的方案包括在妊娠14 - 34周开始产前口服ZDV并持续整个孕期,随后在分娩期静脉注射ZDV,并在婴儿出生后口服ZDV 6周。本文总结了该试验的结果,讨论了结果解读中的局限性,回顾了此ZDV方案对婴儿和妇女潜在的长期不良影响,并提供了关于使用ZDV降低围产期传播以及对接受该治疗的孕妇和婴儿进行医学监测的建议。由于许多感染HIV的妇女的临床状况可能与该试验中的妇女不同,建议应根据每位妇女的临床情况进行调整。必须与该妇女讨论潜在的益处、未知的长期影响以及关于其具体临床情况的知识空白。此信息旨在为该妇女与其医疗服务提供者之间的讨论提供基础,以便该妇女能够权衡此类治疗的风险和益处,并就其治疗做出明智的决定。