美国加州大学旧金山分校Catherine E. Oldenburg团队研究了阿奇霉素预防婴儿死亡的效果。该研究于2024年1月17日发表在《新英格兰医学杂志》上。

在一些撒哈拉以南非洲地区，向1至59个月大的儿童大规模分发阿奇霉素已被证明可以降低儿童全因死亡率，其中12个月以下的婴儿死亡率下降幅度最大。目前尚不清楚在婴儿常规保健就诊中使用阿奇霉素是否能有效预防死亡。

研究组进行了一项随机安慰剂对照试验，在婴儿期（5至12周龄）服用单剂量阿奇霉素（每公斤体重20毫克）与安慰剂进行比较。主要终点是在6个月大之前死亡。在布基纳法索的三个地区，婴儿通过诊所的常规疫苗接种或其他健康儿童就诊以及社区外展招募。在6个月大时评估生命状态。

在2019年9月至2022年10月登记的32877名婴儿中，共有16416名婴儿被随机分配给阿奇霉素，16461名婴儿被分配给安慰剂。阿奇霉素组82名婴儿和安慰剂组75名婴儿在6个月大之前死亡（危险比1.09；95%置信区间[CI]，0.80-1.49；P=0.58）；死亡率的绝对差异为0.04个百分点（95%CI为-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的不良事件发生率有差异。

研究结果表明，在布基纳法索进行的这项试验中，通过现有的医疗保健系统给婴儿服用阿奇霉素并不能防止死亡。

附：英文原文

Title: Azithromycin during Routine Well-Infant Visits to Prevent Death

Author: Ali Sié, Mamadou Ouattara, Mamadou Bountogo, Valentin Boudo, Thierry Ouedraogo, Guillaume Compaoré, Clarisse Dah, Cheik Bagagnan, Elodie Lebas, Huiyu Hu, Jessica Rice, Travis C. Porco, Benjamin F. Arnold, Thomas M. Lietman, Catherine E. Oldenburg

Issue&Volume: 2024-01-17

Abstract:

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.

DOI: NJ202401183900308

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2309495