Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
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DOI：
10.1093/infdis/jir240
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发表时间：
2011-07-15
影响因子：
6.4
通讯作者：
Benn, Christine Stabell
中科院分区：
文献类型：
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作者：
Aaby, Peter;Roth, Adam;Benn, Christine Stabell
背景观察性研究表明，BCG可能对生存有非特异性的有益作用。在几内亚比绍，低出生体重（LBW）儿童在出生时没有给予卡介苗;我们进行了一项出生时卡介苗（早期卡介苗）与延迟卡介苗的随机试验。2004-2008年期间，我们在比绍招募了2 320名出生体重不足儿童。这些孩子在2、6和12个月大的时候被送到家里。试验前婴儿死亡率为250/1000，我们假设LBW儿童的婴儿死亡率降低25%。在试验期间，婴儿死亡率仅为101/1000。在初步分析中，婴儿死亡率降低了17%（死亡率比[MRR] = 0.83 [0.63 -1.08]）。在二次分析中，早期卡介苗是安全的，3天后的MRR为0.49（0.21 -1.15），4周后为0.55（0.34 - 0.89）。新生儿死亡率的下降主要是由于新生儿败血症、呼吸道感染和发热病例减少。早期接种卡介苗对婴儿死亡率的影响，
Background. Observational studies have suggested that BCG may have nonspecific beneficial effects on survival. Low-birth-weight (LBW) children are not given BCG at birth in Guinea-Bissau; we conducted a randomized trial of BCG at birth (early BCG) vs delayed BCG.Methods. In the period 2004-2008 we recruited 2320 LBW children in Bissau. The children were visited at home at 2, 6, and 12 months of age. With a pretrial infant mortality of 250 per 1000, we hypothesized a 25% reduction in infant mortality for LBW children.Results. Infant mortality was only 101 per 1000 during the trial. In the primary analysis, infant mortality was reduced insignificantly by 17% (mortality rate ratio [MRR] = .83 [.63-1.08]). In secondary analyses, early BCG vaccine was safe with an MRR of .49 (.21-1.15) after 3 days and .55 (.34-.89) after 4 weeks. The reduction in neonatal mortality was mainly due to fewer cases of neonatal sepsis, respiratory infection, and fever. The impact of early BCG on infant mortality was marked for children weighing