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单剂量阿奇霉素治疗布基纳法索儿童生长迟缓:一项随机对照试验。

Single-dose azithromycin for child growth in Burkina Faso: a randomized controlled trial.

机构信息

Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.

Francis I Proctor Foundation, University of California, 513 Parnassus Ave, Box 0412, San Francisco, CA, 94143, USA.

出版信息

BMC Pediatr. 2021 Mar 17;21(1):130. doi: 10.1186/s12887-021-02601-7.

DOI:10.1186/s12887-021-02601-7
PMID:33731058
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7967941/
Abstract

BACKGROUND

In lower resource settings, previous randomized controlled trials have demonstrated evidence of increased weight gain following antibiotic administration in children with acute illness. We conducted an individually randomized trial to assess whether single dose azithromycin treatment causes weight gain in a general population sample of children in Burkina Faso.

METHODS

Children aged 8 days to 59 months were enrolled in November 2019 and followed through June 2020 in Nouna Town, Burkina Faso. Participants were randomly assigned to a single oral dose of azithromycin (20 mg/kg) or matching placebo. Anthropometric measurements were collected at baseline and 14 days and 6 months after enrollment. The primary anthropometric outcome was weight gain velocity in g/kg/day from baseline to 14 days and 6 months in separate linear regression models.

RESULTS

Of 450 enrolled children, 230 were randomly assigned to azithromycin and 220 to placebo. Median age was 26 months (IQR 16 to 38 months) and 51% were female. At 14 days, children in the azithromycin arm gained a mean difference of 0.9 g/kg/day (95% CI 0.2 to 1.6 g/kg/day, P = 0.01) more than children in the placebo arm. There was no difference in weight gain velocity in children receiving azithromycin compared to placebo at 6 months (mean difference 0.04 g/kg/day, 95% CI - 0.05 to 0.13 g/kg/day, P = 0.46). There were no significant differences in other anthropometric outcomes.

CONCLUSIONS

Transient increases in weight gain were observed after oral azithromycin treatment, which may provide short-term benefits.

CLINICAL TRIALS REGISTRATION

ClinicalTrials.gov NCT03676751 . Registered 19/09/2018.

摘要

背景

在资源较少的环境下,先前的随机对照试验已经证明,在急性疾病的儿童中使用抗生素后会导致体重增加。我们进行了一项个体随机试验,以评估单剂量阿奇霉素治疗是否会导致布基纳法索普通人群样本中的儿童体重增加。

方法

2019 年 11 月在布基纳法索努纳镇招募了 8 天至 59 个月大的儿童,并在 2020 年 6 月进行了随访。参与者被随机分配接受单次口服阿奇霉素(20mg/kg)或匹配的安慰剂。在基线和入组后 14 天和 6 个月时采集人体测量学测量值。主要人体测量学结局是从基线到 14 天和 6 个月的体重增加速度,分别在单独的线性回归模型中进行评估。

结果

450 名入组的儿童中,230 名被随机分配至阿奇霉素组,220 名被分配至安慰剂组。中位年龄为 26 个月(IQR 16 至 38 个月),51%为女性。在 14 天时,阿奇霉素组的儿童体重增加速度比安慰剂组平均快 0.9g/kg/天(95%CI 0.2 至 1.6 g/kg/天,P=0.01)。在 6 个月时,接受阿奇霉素治疗的儿童与安慰剂相比,体重增加速度没有差异(平均差异 0.04g/kg/天,95%CI -0.05 至 0.13 g/kg/天,P=0.46)。其他人体测量学结局也没有显著差异。

结论

口服阿奇霉素治疗后体重出现短暂增加,这可能带来短期获益。

临床试验注册

ClinicalTrials.gov NCT03676751。注册于 2018 年 9 月 19 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f712/7967941/0576bf40c4bd/12887_2021_2601_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f712/7967941/0576bf40c4bd/12887_2021_2601_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f712/7967941/0576bf40c4bd/12887_2021_2601_Fig1_HTML.jpg

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