Silverman N S, Watts D H, Hitti J, Money D M, Livingston E, Axelrod J, Ernest J M, Robbins D, DiVito M M
Department of Obstetrics and Gynecology, Thomas Jefferson University Hospital, Philadelphia, PA.
Infect Dis Obstet Gynecol. 1998;6(6):237-43. doi: 10.1002/(SICI)1098-0997(1998)6:6<237::AID-IDOG3>3.0.CO;2-E.
To study maternal and neonatal effects of combination nucleoside analog therapy administered to human immunodeficiency virus (HIV)-infected pregnant women for maternal indications.
A multicenter, prospective observational study was undertaken at six perinatal centers in the United States and Canada that supported regional referral programs for the treatment of HIV-infected pregnant women. Demographic, laboratory, and pregnancy outcome data were collected for 39 women whose antiretroviral treatment regimens were expanded to include more than one nucleoside analog for maternal indications. The 40 newborns were monitored at pediatric referral centers through at least three months of age to ascertain their HIV infection status.
For all 39 women, zidovudine (ZDV) therapy was instituted at 13.4 +/- 8.2 weeks, with a second agent (lamivudine [3TC] in 85% of cases) being added at a mean gestational age of 17.6 weeks. Duration of therapy with two agents was 20.6 +/- 10.4 weeks overall, with no women stopping medications because of side effects or toxicity. No significant changes in maternal laboratory values were seen, except for an increase in mean corpuscular volume, over the course of pregnancy. No clinically significant adverse neonatal outcomes were noted, with all but the three preterm newborns leaving hospital with their mothers. Neonatal anemia (hematocrit < 50%) was seen in 62% of newborns, with no children needing transfusion; mild elevations of liver function tests, primarily aspartate aminotransferase, were noted in 58% of newborns tested, though none were clinically jaundiced. Overall rate of neonatal HIV infection was 2.5% (95% confidence interval: 0.1-13.2%).
Combination antiretroviral therapy during pregnancy with two nucleoside analogs was well-tolerated by mothers and newborns, with no significant short-term toxicities or side effects noted. Surveillance of exposed newborns' hematologic and liver function appears warranted.
研究针对有母体指征的人类免疫缺陷病毒（HIV）感染孕妇采用联合核苷类似物疗法对母婴的影响。
在美国和加拿大的六个围产期中心开展了一项多中心前瞻性观察性研究，这些中心为HIV感染孕妇的区域转诊项目提供支持。收集了39名孕妇的人口统计学、实验室检查及妊娠结局数据，她们的抗逆转录病毒治疗方案扩大至包括一种以上用于母体指征的核苷类似物。40名新生儿在儿科转诊中心接受监测，直至至少3月龄，以确定其HIV感染状况。
所有39名孕妇中，齐多夫定（ZDV）治疗于13.4±8.2周开始，第二种药物（85%的病例为拉米夫定[3TC]）于平均孕周17.6周添加。两种药物的治疗总时长为20.6±10.4周，没有孕妇因副作用或毒性而停药。在妊娠过程中，除平均红细胞体积增加外，母体实验室检查值未见显著变化。未观察到具有临床意义的不良新生儿结局，除3名早产新生儿外，所有新生儿均与母亲一同出院。62%的新生儿出现新生儿贫血（血细胞比容<50%），无儿童需要输血；58%接受检测的新生儿肝功能检查轻度升高，主要是天冬氨酸转氨酶升高，不过均无临床黄疸表现。新生儿HIV感染总体发生率为2.5%（95%置信区间：0.1 - 13.2%）。
孕期使用两种核苷类似物进行联合抗逆转录病毒治疗，母亲和新生儿耐受性良好，未观察到显著的短期毒性或副作用。对暴露新生儿的血液学和肝功能进行监测似乎是必要的。
