Breastfeeding plus infant zidovudine prophylaxis for 6 months vs formula feeding plus infant zidovudine for 1 month to reduce mother-to-child HIV transmission in Botswana - A randomized trial: The Mashi study
Breastfeeding plus infant zidovudine prophylaxis for 6 months vs formula feeding plus infant zidovudine for 1 month to reduce mother-to-child HIV transmission in Botswana - A randomized trial: The Mashi study
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DOI：
10.1001/jama.296.7.794
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发表时间：
2006-08-16
影响因子：
120.7
通讯作者：
Essex, Max
中科院分区：
文献类型：
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作者：
Thior, Ibou;Lockman, Shahin;Essex, Max
目的比较两种婴儿喂养策略预防HIV产后母婴传播的有效性和安全性。设计、设置和患者A 2×2因子随机临床试验，包括围产期(单剂量奈韦拉平与安慰剂)和产后婴儿喂养(配方奶与婴儿齐多夫定预防母乳喂养)干预。在博茨瓦纳，2001年3月27日至2003年10月29日期间，从4家地区医院随机抽取了1200名艾滋病毒阳性孕妇。婴儿在出生时进行评估，从7个月到7个月，9个月，然后每3个月到18个月。干预所有母亲从妊娠34周开始每天口服300 mg齐多夫定300 mg，并在分娩期间服用。母亲和婴儿随机接受单剂量奈韦拉平或安慰剂治疗。婴儿随机分为母乳喂养加预防用药组(母乳喂养加用齐多夫定)6个月，配方奶粉喂养加婴儿用齐多夫定1个月(配方奶粉喂养)。主要观察指标对1179名婴儿进行初步疗效(7个月时HIV感染，18个月时无HIV感染)和安全性(7个月时发生婴儿不良事件)终点评估。结果7个月内HIV感染率分别为5.6%(配方奶组32例)和9.0%(母乳喂养+齐多夫定组51例)(P=0.05)。04；差异的95%可信区间，-6.4%至-0.4%)。18个月时婴儿累计死亡率或HIV感染率分别为80例(13.9%，配方奶喂养)和86例(15.1%，母乳喂养加齐多夫定)(P=0.05)。60；差值的95%可信区间为-5.3%至2.9%)。配方奶粉喂养组婴儿7个月累计死亡率显著高于母乳喂养+齐多夫定组(9.3%vs4.9%；P=0.05)。003)，但这种差异在7个月以后逐渐缩小，因此18个月的死亡时间分布没有显著差异(P=。结论使用齐多夫定预防母乳喂养在预防HIV产后传播方面不如配方奶喂养有效，但7个月时的死亡率较低。这两种策略在18个月内都有类似的无艾滋病毒生存。这些结果表明，在撒哈拉以南非洲，配方奶喂养婴儿的风险很大，需要研究替代战略。
Context Postnatal transmission of human immunodeficiency virus-1 (HIV) via breast-feeding reverses gains achieved by perinatal antiretroviral interventions.Objective To compare the efficacy and safety of 2 infant feeding strategies for the prevention of postnatal mother-to-child HIV transmission.Design, Setting, and Patients A 2 x 2 factorial randomized clinical trial with peripartum (single-dose nevirapine vs placebo) and postpartum infant feeding ( formula vs breastfeeding with infant zidovudine prophylaxis) interventions. In Botswana between March 27, 2001, and October 29, 2003, 1200 HIV-positive pregnant women were randomized from 4 district hospitals. Infants were evaluated at birth, monthly until age 7 months, at age 9 months, then every third month through age 18 months.Intervention All of the mothers received zidovudine 300 mg orally twice daily from 34 weeks' gestation and during labor. Mothers and infants were randomized to receive single-dose nevirapine or placebo. Infants were randomized to 6 months of breastfeeding plus prophylactic infant zidovudine (breastfed plus zidovudine), or formula feeding plus 1 month of infant zidovudine ( formula fed).Main Outcome Measures Primary efficacy ( HIV infection by age 7 months and HIV-free survival by age 18 months) and safety ( occurrence of infant adverse events by 7 months of age) end points were evaluated in 1179 infants.Results The 7-month HIV infection rates were 5.6% ( 32 infants in the formula-fed group) vs 9.0% ( 51 infants in the breastfed plus zidovudine group) (P=. 04; 95% confidence interval for difference, - 6.4% to - 0.4%). Cumulative mortality or HIV infection rates at 18 months were 80 infants ( 13.9%, formula fed) vs 86 infants (15.1% breastfed plus zidovudine) ( P=. 60; 95% confidence interval for difference, - 5.3% to 2.9%). Cumulative infant mortality at 7 months was significantly higher for the formula-fed group than for the breastfed plus zidovudine group (9.3% vs 4.9%; P=. 003), but this difference diminished beyond month 7 such that the time-to-mortality distributions through age 18 months were not significantly different ( P=. 21).Conclusions Breastfeeding with zidovudine prophylaxis was not as effective as formula feeding in preventing postnatal HIV transmission, but was associated with a lower mortality rate at 7 months. Both strategies had comparable HIV-free survival at 18 months. These results demonstrate the risk of formula feeding to infants in sub-Saharan Africa, and the need for studies of alternative strategies.