本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2023.27393

摘要内容如下：

重要性

在撒哈拉以南非洲，阿奇霉素的反复大规模分发已被证明可将儿童死亡率降低14%。然而，估计的效果因地点而异，这表明干预措施在不同的地理区域、时间段或条件下可能无效。

目的

评估一年两次阿奇霉素在季节性疟疾化学预防中降低儿童死亡率的效果。

设计、设置和参与者

这项评估单剂量阿奇霉素预防全因儿童死亡疗效的随机安慰剂对照试验纳入了布基纳法索西北部农村努纳地区的341个社区。参与者是生活在研究社区的1至59个月的儿童。

干预措施

社区以1:1的比例随机接受口服阿奇霉素或安慰剂分配。从2019年8月至2023年2月，1至59个月的儿童每年接受两次单剂量治疗，为期3年（6次分配）。

主要成果和措施

主要结果是在每年两次的人口普查期间测量的全因儿童死亡率。

结果

阿奇霉素组共纳入34399名儿童（平均[SD]年龄，25.2[18]个月），安慰剂组共纳入33847名儿童（平均[SD]年龄，25.6[18]个月）。平均（SD）90.1%（16.0%）的普查儿童接受了阿奇霉素组的预定研究药物，89.8%（17.1%）的普查儿童接受了安慰剂组的预定研究药物。在阿奇霉素组中，在60592人年中记录了498例死亡（8.2例死亡/1000人年）。在安慰剂组中，在58547人年中记录了588例死亡（10.0例死亡/1000人年）。死亡率的发生率比值为0.82（95%CI，0.67-1.02；与安慰剂组相比，阿奇霉素组P=0.07）。1~11个月的发病率比值为0.99（95%CI，0.72-1.36），12~23个月的发病率比值为0.92（95%CI，0.67-1.27），24~59个月的发病率比值为0.73（95%CI，0.57-0.94）。

结论和相关性

儿童（1-59个月）的死亡率在一年两次的大规模阿奇霉素分发中较低，在季节性疟疾化学预防也在分发的环境中，但差异没有统计学意义。该研究可能在检测临床相关差异方面动力不足。

试用注册

ClinicalTrials.gov标识符：NCT03676764。

英文原文如下：

Abstracts

Importance  Repeated mass distribution of azithromycin has been shown to reduce childhood mortality by 14% in sub-Saharan Africa. However, the estimated effect varied by location, suggesting that the intervention may not be effective in different geographical areas, time periods, or conditions.

Objective  To evaluate the efficacy of twice-yearly azithromycin to reduce mortality in children in the presence of seasonal malaria chemoprevention.

Design, Setting, and Participants  This cluster randomized placebo-controlled trial evaluating the efficacy of single-dose azithromycin for prevention of all-cause childhood mortality included 341 communities in the Nouna district in rural northwestern Burkina Faso. Participants were children aged 1 to 59 months living in the study communities.

Interventions  Communities were randomized in a 1:1 ratio to receive oral azithromycin or placebo distribution. Children aged 1 to 59 months were offered single-dose treatment twice yearly for 3 years (6 distributions) from August 2019 to February 2023.

Main Outcomes and Measures  The primary outcome was all-cause childhood mortality, measured during a twice-yearly enumerative census.

Results  A total of 34 399 children (mean [SD] age, 25.2 [18] months) in the azithromycin group and 33 847 children (mean [SD] age, 25.6 [18] months) in the placebo group were included. A mean (SD) of 90.1% (16.0%) of the censused children received the scheduled study drug in the azithromycin group and 89.8% (17.1%) received the scheduled study drug in the placebo group. In the azithromycin group, 498 deaths were recorded over 60 592 person-years (8.2 deaths/1000 person-years). In the placebo group, 588 deaths were recorded over 58 547 person-years (10.0 deaths/1000 person-years). The incidence rate ratio for mortality was 0.82 (95% CI, 0.67-1.02; P = .07) in the azithromycin group compared with the placebo group. The incidence rate ratio was 0.99 (95% CI, 0.72-1.36) in those aged 1 to 11 months, 0.92 (95% CI, 0.67-1.27) in those aged 12 to 23 months, and 0.73 (95% CI, 0.57-0.94) in those aged 24 to 59 months.

Conclusions and Relevance  Mortality in children (aged 1-59 months) was lower with biannual mass azithromycin distribution in a setting in which seasonal malaria chemoprevention was also being distributed, but the difference was not statistically significant. The study may have been underpowered to detect a clinically relevant difference.

Trial Registration  ClinicalTrials.gov Identifier: NCT03676764.

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