Moodley J, Moodley D, Pillay K, Coovadia H, Saba J, van Leeuwen R, Goodwin C, Harrigan P R, Moore K H, Stone C, Plumb R, Johnson M A
Department of Obstetrics and Paediatrics, University of Natal, Durban, South Africa.
J Infect Dis. 1998 Nov;178(5):1327-33. doi: 10.1086/314431.
The safety, pharmacokinetics, and antiretroviral activity of lamivudine alone and in combination with zidovudine was studied in pregnant women infected with human immunodeficiency virus type 1 (HIV-1) and their neonates. Women received the drugs orally from week 38 of pregnancy to 1 week after delivery. Neonate therapy began 12 h after delivery and continued for 1 week. Both treatment regimens were well-tolerated in women and newborns. Lamivudine and zidovudine pharmacokinetics in pregnant women were similar to those in nonpregnant adults. Lamivudine and zidovudine freely crossed the placenta and were secreted in breast milk. Neonatal lamivudine clearance was about half that in pediatric patients; zidovudine clearance was consistent with previous reports. HIV-1 RNA could be quantified in 17 of the 20 women. At the onset of labor/delivery, mean virus load had decreased by approximately 1.5 log10 copies/mL in both treatment cohorts. Although not definitive for HIV-1 infection status, all neonates had HIV-1 RNA levels below the limit of quantification at birth and at ages 1 and 2 weeks.
对感染1型人类免疫缺陷病毒（HIV-1）的孕妇及其新生儿，研究了拉米夫定单独使用及与齐多夫定联合使用时的安全性、药代动力学和抗逆转录病毒活性。孕妇从妊娠38周开始口服药物，直至产后1周。新生儿治疗在出生后12小时开始，持续1周。两种治疗方案在孕妇和新生儿中耐受性良好。拉米夫定和齐多夫定在孕妇中的药代动力学与非妊娠成年人相似。拉米夫定和齐多夫定可自由通过胎盘并分泌到母乳中。新生儿拉米夫定清除率约为儿科患者的一半；齐多夫定清除率与先前报告一致。20名女性中有17名可对HIV-1 RNA进行定量。在分娩开始时，两个治疗组的平均病毒载量均下降了约1.5 log10拷贝/mL。尽管对于HIV-1感染状态并不确定，但所有新生儿在出生时以及1周和2周龄时的HIV-1 RNA水平均低于定量下限。
