Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.
Francis I Proctor Foundation, University of California, San Francisco, California.
Am J Trop Med Hyg. 2022 Nov 7;107(6):1331-1336. doi: 10.4269/ajtmh.22-0245. Print 2022 Dec 14.
Mass azithromycin distribution reduces all-cause childhood mortality in some high-mortality settings in sub-Saharan Africa. Although the greatest benefits have been shown in children 1 to 5 months old living in areas with high mortality rates, no evidence of a benefit was found of neonatal azithromycin in a low-mortality setting on mortality at 6 months. We conducted a 1:1 randomized, placebo-controlled trial evaluating the effect of a single oral 20-mg/kg dose of azithromycin or matching placebo administered during the neonatal period on all-cause and cause-specific infant mortality at 12 months of age in five regions of Burkina Faso. Neonates were eligible if they were between the ages of 8 and 27 days and weighed at least 2,500 g at enrollment. Cause of death was determined via the WHO 2016 verbal autopsy tool. We compared all-cause and cause-specific mortality using binomial regression. Of 21,832 infants enrolled in the study, 116 died by 12 months of age. There was no significant difference in all-cause mortality between the azithromycin and placebo groups (azithromycin: 52 deaths, 0.5%; placebo, 64 deaths, 0.7%; hazard ratio, 0.81; 95% CI, 0.56-1.17; P = 0.30). There was no evidence of a difference in the distribution of causes of death (P = 0.40) and no significant difference in any specific cause of death between groups. Mortality rates were low at 12 months of age, and there was no evidence of an effect of neonatal azithromycin on all-cause or cause-specific mortality.
大规模使用阿奇霉素可以降低撒哈拉以南非洲一些高死亡率地区的儿童全因死亡率。虽然阿奇霉素对 1 至 5 月龄、生活在高死亡率地区的儿童效果最佳，但在低死亡率环境中，对新生儿使用阿奇霉素并未显示对 6 个月时的死亡率有任何益处。我们进行了一项 1:1 随机、安慰剂对照试验，评估在新生儿期给予单口服 20 毫克/公斤剂量的阿奇霉素或匹配的安慰剂对布基纳法索五个地区 12 月龄时全因和病因特异性婴儿死亡率的影响。新生儿如果年龄在 8 至 27 天之间，且在入组时体重至少为 2500 克，则有资格参加。通过世界卫生组织 2016 年的口头尸检工具确定死因。我们使用二项式回归比较全因和病因特异性死亡率。在研究中纳入的 21832 名婴儿中，有 116 名在 12 个月时死亡。阿奇霉素组和安慰剂组之间的全因死亡率没有显著差异（阿奇霉素：52 例死亡，0.5%；安慰剂：64 例死亡，0.7%；风险比，0.81；95%CI，0.56-1.17；P = 0.30）。死因分布无差异（P = 0.40），两组间任何特定死因的死亡率也无显著差异。12 个月时的死亡率较低，且新生儿使用阿奇霉素对全因或病因特异性死亡率没有影响。
