本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2309495

摘要内容如下：

背景

在一些撒哈拉以南非洲地区，向1至59个月的儿童大规模分发阿奇霉素已被证明可降低儿童全因死亡率，其中12个月以下婴儿的死亡率降幅最大。目前尚不清楚在婴儿的常规保健访问中给予阿奇霉素是否能有效预防死亡。

方法

我们进行了一项随机、安慰剂对照试验，在婴儿期（5至12周龄）给予单剂量阿奇霉素（每公斤体重20毫克）与安慰剂进行比较。主要终点是6个月前的死亡。在布基纳法索的三个地区，通过常规疫苗接种或诊所的其他健康儿童访问以及社区外展活动招募婴儿。在6个月大时评估生命状态。

结果

在2019年9月至2022年10月登记的32，877名婴儿中，共有16，416名婴儿被随机分配至阿奇霉素组，16，461名婴儿被随机分配至安慰剂组。阿奇霉素组有82名婴儿和安慰剂组有75名婴儿在6个月前死亡（风险比为1.09；95%置信区间[CI]，0.80至1.49；P=0.58）；死亡率的绝对差异为0.04个百分点（95%CI，-0.10至0.21）。没有证据表明阿奇霉素对任何预先指定的亚组（包括根据年龄、性别和基线体重定义的亚组）的死亡率有影响，也没有证据表明两个试验组之间的不良事件发生率存在差异。

结论

在布基纳法索进行的这项试验中，我们发现通过现有的卫生保健系统给婴儿服用阿奇霉素并不能预防死亡。（由比尔和梅琳达·盖茨基金会资助；Chat ClinicalTrials.gov，NCT03676764）。

英文原文如下：

Abstracts

BACKGROUND  Mass distribution of azithromycin to children 1 to 59 months of age has been shown to reduce childhood all-cause mortality in some sub-Saharan African regions, with the largest reduction seen among infants younger than 12 months of age. Whether the administration of azithromycin at routine health care visits for infants would be effective in preventing death is unclear.

METHODS  We conducted a randomized, placebo-controlled trial of a single dose of azithromycin (20 mg per kilogram of body weight) as compared with placebo, administered during infancy (5 to 12 weeks of age). The primary end point was death before 6 months of age. Infants were recruited at routine vaccination or other well-child visits in clinics and through community outreach in three regions of Burkina Faso. Vital status was assessed at 6 months of age.

RESULTS  Of the 32,877 infants enrolled from September 2019 through October 2022, a total of 16,416 infants were randomly assigned to azithromycin and 16,461 to placebo. Eighty-two infants in the azithromycin group and 75 infants in the placebo group died before 6 months of age (hazard ratio, 1.09; 95% confidence interval [CI], 0.80 to 1.49; P = 0.58); the absolute difference in mortality was 0.04 percentage points (95% CI, -0.10 to 0.21). There was no evidence of an effect of azithromycin on mortality in any of the prespecified subgroups, including subgroups defined according to age, sex, and baseline weight, and no evidence of a difference between the two trial groups in the incidence of adverse events.

CONCLUSIONS  In this trial conducted in Burkina Faso, we found that administration of azithromycin to infants through the existing health care system did not prevent death. (Funded by the Bill and Melinda Gates Foundation; CHAT ClinicalTrials.gov number, NCT03676764.).

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