Effect of breastfeeding and formula feeding on transmission of HIV-1: a randomized clinical trial.
Effect of breastfeeding and formula feeding on transmission of HIV-1: a randomized clinical trial.
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DOI：
10.1097/00006254-200008000-00010
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发表时间：
2000-03
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影响因子：
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通讯作者：
R. Nduati;G. John;D. Mbori-ngacha;B. Richardson;J. Overbaugh;A. Mwatha;J. Ndinya‐Achola;J. Bwayo;Onyango Fe;J. Hughes;J. Kreiss
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作者：
R. Nduati;G. John;D. Mbori-ngacha;B. Richardson;J. Overbaugh;A. Mwatha;J. Ndinya‐Achola;J. Bwayo;Onyango Fe;J. Hughes;J. Kreiss
1.人类免疫缺陷病毒1型（HIV-1）的传播已知可通过母乳喂养发生，但其危险程度尚未确切界定。在发展中国家，母乳传播HIV-1的风险是否超过配方奶粉相关性肺炎死亡的潜在风险尚不清楚。确定母乳传播HIV-1的频率，并比较母乳喂养和配方奶粉喂养婴儿的死亡率和无HIV-1存活率。随机临床试验于1992年11月至1998年7月在肯尼亚内罗毕的产前诊所进行，中位随访期为24个月。参与者425名HIV-1血清阳性，抗逆转录病毒初治的孕妇入组，401对母婴被纳入试验终点分析。干预母婴对被随机分为母乳喂养组（n = 212）和配方奶粉喂养组（n = 213）。主要结果指标比较2个干预组婴儿出生后头2年内的HIV-1感染和死亡情况。结果：母乳喂养组和配方奶粉喂养组对指定喂养方式的依从性分别为96%和70%（P<0.001）。母乳喂养的中位持续时间为17个月。在纳入分析的401名婴儿中，94%的婴儿随访至HIV-1感染或死亡终点：83%的婴儿随访至HIV-1感染终点，93%的婴儿随访至死亡终点。母乳喂养组24个月时HIV-1感染的累积概率为36.7%（95%置信区间[CI]，29.4%-44.0%），配方奶粉组为20.5%（95% CI，14.0%-27.0%）（P = 0.001）。估计母乳传播率为16.2%（95%CI，6.5%-25.9%）。母乳喂养组中44%的HIV-1感染可归因于母乳。大多数母乳传播发生在早期，两组之间75%的风险差异发生在6个月内，尽管传播在整个暴露期间持续存在。两组的2年死亡率相似（母乳喂养组，24.4% [95% CI，18.2%-30.7%] vs配方奶粉喂养组，20.0% [95% CI，14.4%-25.6%]; P = 0.30）。母乳喂养组的2年无HIV-1生存率显著低于配方奶粉喂养组（分别为58.0%和70.0%; P = 0.02）。结论在本随机临床试验中，HIV-1的母乳传播频率为16.2%，大多数感染发生在母乳喂养早期。母乳替代品的使用预防了44%的婴儿感染，并与显着提高无HIV-1存活率相关。
CONTEXT Transmission of human immunodeficiency virus type 1 (HIV-1) is known to occur through breastfeeding, but the magnitude of risk has not been precisely defined. Whether breast milk HIV-1 transmission risk exceeds the potential risk of formula-associated diarrheal mortality in developing countries is unknown. OBJECTIVES To determine the frequency of breast milk transmission of HIV-1 and to compare mortality rates and HIV-1-free survival in breastfed and formula-fed infants. DESIGN AND SETTING Randomized clinical trial conducted from November 1992 to July 1998 in antenatal clinics in Nairobi, Kenya, with a median follow-up period of 24 months. PARTICIPANTS Of 425 HIV-1-seropositive, antiretroviral-naive pregnant women enrolled, 401 mother-infant pairs were included in the analysis of trial end points. INTERVENTIONS Mother-infant pairs were randomized to breastfeeding (n = 212) vs formula feeding arms (n = 213). MAIN OUTCOME MEASURES Infant HIV-1 infection and death during the first 2 years of life, compared between the 2 intervention groups. RESULTS Compliance with the assigned feeding modality was 96% in the breastfeeding arm and 70% in the formula arm (P<.001). Median duration of breastfeeding was 17 months. Of the 401 infants included in the analysis, 94% were followed up to HIV-1 infection or mortality end points: 83% for the HIV-1 infection end point and 93% to the mortality end point. The cumulative probability of HIV-1 infection at 24 months was 36.7% (95% confidence interval [CI], 29.4%-44.0%) in the breastfeeding arm and 20.5% (95% CI, 14.0%-27.0%) in the formula arm (P = .001). The estimated rate of breast milk transmission was 16.2% (95% CI, 6.5%-25.9%). Forty-four percent of HIV-1 infection in the breastfeeding arm was attributable to breast milk. Most breast milk transmission occurred early, with 75% of the risk difference between the 2 arms occurring by 6 months, although transmission continued throughout the duration of exposure. The 2-year mortality rates in both arms were similar (breastfeeding arm, 24.4% [95% CI, 18.2%-30.7%] vs formula feeding arm, 20.0% [95% CI, 14.4%-25.6%]; P = .30). The rate of HIV-1-free survival at 2 years was significantly lower in the breastfeeding arm than in the formula feeding arm (58.0% vs 70.0%, respectively; P = .02). CONCLUSIONS The frequency of breast milk transmission of HIV-1 was 16.2% in this randomized clinical trial, and the majority of infections occurred early during breastfeeding. The use of breast milk substitutes prevented 44% of infant infections and was associated with significantly improved HIV-1-free survival.