Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.
J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.
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.
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.
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 <1.5 kg (MRR = .43 [.21-.85]) who had lower coverage for diphtheria-tetanus-pertussis vaccinations.
Though early BCG did not reduce infant mortality significantly, it may have a beneficial effect in the neonatal period. This could be important for public health because BCG is often delayed in low-income countries.
观察性研究表明，卡介苗可能对生存有非特异性的有益影响。在几内亚比绍，低出生体重（LBW）儿童出生时不接种卡介苗；我们进行了一项出生时接种卡介苗（早期卡介苗）与延迟接种卡介苗的随机试验。
在 2004-2008 年期间，我们在比绍招募了 2320 名 LBW 儿童。这些儿童在 2、6 和 12 个月大时在家中接受访视。根据预先试验的婴儿死亡率为每 1000 人 250 人，我们假设 LBW 儿童的婴儿死亡率降低 25%。
试验期间婴儿死亡率仅为每 1000 人 101 人。在主要分析中，婴儿死亡率降低了 17%（死亡率比 [MRR] =.83 [.63-1.08]），但无统计学意义。在二次分析中，早期卡介苗疫苗在接种后 3 天的 MRR 为.49（.21-1.15），接种后 4 周的 MRR 为.55（.34-0.89），安全性良好。新生儿死亡率的降低主要是由于新生儿败血症、呼吸道感染和发热的病例减少。早期卡介苗对婴儿死亡率的影响在体重<1.5kg 的儿童中更为显著（MRR =.43 [.21-.85]），这些儿童的白喉-破伤风-百日咳疫苗接种覆盖率较低。
虽然早期卡介苗接种并未显著降低婴儿死亡率，但它可能在新生儿期有有益的效果。这对于公共卫生可能很重要，因为卡介苗在低收入国家经常延迟接种。
