Lancet. 2002 Apr 6;359(9313):1178-86. doi: 10.1016/S0140-6736(02)08214-4.
Large reductions in transmission of HIV-1 from mother to child have been achieved in more-developed countries due to the use of antiretrovirals. Short-course regimens, suitable for resource-poor countries, have also been shown to significantly reduce peripartum HIV-1 transmission. We assessed the efficacy of short-course regimens with zidovudine and lamivudine in a predominantly breastfeeding population.
We did a randomised, double-blind, placebo-controlled trial in South Africa, Uganda, and Tanzania. Between June, 1996, and January, 2000, HIV-1-infected mothers were randomised to one of four regimens: A, zidovudine plus lamivudine starting at 36 weeks' gestation, followed by oral intrapartum dosing and by 7 days' postpartum dosing of mothers and infants; B, as regimen A, but without the prepartum component; C, intrapartum zidovudine and lamivudine only; or placebo. From Feb 18, 1998, onward, women were only randomised to one of the active treatment groups. Primary outcomes were HIV-1 infection and child mortality at week 6 and month 18 after birth. Analysis was by intention to treat of those randomised before Feb 18, 1998.
1797 HIV-1-infected women were identified. Week 6 HIV-1 transmission rates were 5.7% for group A, 8.9% for group B, 14.2% for group C, and 15.3% for the placebo group. Respective relative risks for HIV-1 transmission in the treatment groups compared with placebo were 0.37 (95% CI 0.21-0.65), 0.58 (0.36-0.94), and 0.93 (0.62-1.40). For the combined endpoint of HIV-1 infection and infant mortality at week 6 rates were 7.0%, 11.6%, 17.5%, and 18.1%, respectively, with relative risks of 0.39 (0.24-0.64), 0.64 (0.42-0.97), and 0.97 (0.68-1.38). 1081 (74%) of the women analysed initiated breastfeeding. Based on an interval-censored survival analysis, HIV-1 infection rates at month 18 were 15% (95% CI 9-23), 18% (12-26), 20% (13-30) and 22% (16-30), respectively.
Although at week 6 after birth, regimens A and B were effective in reducing HIV-1 transmission, benefits have diminished considerably after 18 months of follow-up. Introduction of short-course regimens to prevent mother-to-child transmission of HIV-1 in less-developed countries should be accompanied by interventions to minimise the risk of subsequent transmission via breastfeeding.
在较为发达国家，由于使用抗逆转录病毒药物，已实现了HIV-1母婴传播的大幅减少。适用于资源匮乏国家的短程治疗方案也已显示能显著降低围产期HIV-1传播。我们评估了齐多夫定和拉米夫定短程治疗方案在以母乳喂养为主的人群中的疗效。
我们在南非、乌干达和坦桑尼亚进行了一项随机、双盲、安慰剂对照试验。1996年6月至2000年1月期间，将感染HIV-1的母亲随机分为四种治疗方案之一：A组，从妊娠36周开始使用齐多夫定加拉米夫定，随后进行口服分娩期给药以及母亲和婴儿产后7天给药；B组，同A组方案，但无产前用药部分；C组，仅在分娩期使用齐多夫定和拉米夫定；或安慰剂组。从1998年2月18日起，女性仅被随机分配至活性治疗组之一。主要结局为出生后第6周和第18个月时的HIV-1感染及儿童死亡率。对1998年2月18日前随机分组的患者按意向性治疗进行分析。
共识别出1797名感染HIV-1的女性。A组第6周时HIV-1传播率为5.7%，B组为8.9%，C组为14.2%，安慰剂组为15.3%。与安慰剂组相比，各治疗组HIV-1传播的相对风险分别为0.37（95%CI 0.21 - 0.65）、0.58（0.36 - 0.94）和0.93（0.62 - 1.40）。对于第6周时HIV-1感染和婴儿死亡的综合终点，发生率分别为7.0%、11.6%、17.5%和18.1%，相对风险分别为0.39（0.24 - 0.64）、0.64（0.42 - 0.97）和0.97（0.68 - 1.38）。分析的女性中有1081名（7见%）开始母乳喂养。基于区间删失生存分析，第18个月时HIV-1感染率分别为15%（95%CI 9 - 23）、18%（12 - 26）、20%（13 - 30）和22%（16 - 30）。
尽管出生后第6周时，A组和B组方案在降低HIV-1传播方面有效，但在18个月的随访后益处已大幅减少。在欠发达国家引入预防HIV-1母婴传播的短程治疗方案时，应同时采取干预措施以尽量降低随后通过母乳喂养传播的风险。
