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在坦桑尼亚 MORDOR 试验中,对学龄前儿童进行单剂量阿奇霉素每半年治疗以降低死亡率:对阿奇霉素耐药性的影响。

Biannual Treatment of Preschool Children with Single Dose Azithromycin to Reduce Mortality: Impact on Azithromycin Resistance in the MORDOR Trial in Tanzania.

机构信息

Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland.

Infectious Disease Clinical Research Program, Uniformed University of the Health Sciences, Bethesda, Maryland.

出版信息

Am J Trop Med Hyg. 2020 Sep;103(3):1301-1307. doi: 10.4269/ajtmh.19-0086.

DOI:10.4269/ajtmh.19-0086
PMID:32067633
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7470586/
Abstract

The study showed that administration of biannual, single-dose azithromycin to preschool children reduces mortality. We sought to evaluate its impact on azithromycin resistance. Thirty randomly selected communities in Kilosa district, Tanzania, were randomized to receive 6-monthly single-dose azithromycin (∼20 mg/kg) versus placebo treatment of children aged 1-59 months. From each community, 40 children (aged 1-59 months) were randomly selected at baseline, 12 and 24 months. Isolation and resistance testing of and were evaluated using nasopharyngeal and rectal swabs, respectively. The carriage prevalence and the proportion of azithromycin-resistant isolates were determined using disk diffusion. At baseline, the characteristics of the randomly selected children were similar by treatment arms. Both at baseline and in annual cross-sectional surveys, rates of and isolation between treatment arms were similar. The proportions of azithromycin-resistant isolates in the children in communities treated with azithromycin versus placebo at baseline, 12 months, and 24 months were 26.5% (18.1%; = 0.26), 26.8% (16.5%; = 0.29), and 13.4% (17.0%; = 0.57), respectively. The proportions of azithromycin-resistant isolates at baseline, 12 months, and 24 months in the azithromycin (versus placebo) arms were 14.9% (18.9%; = 0.16), 21.5% (16.6%; = 0.10), and 14.9% (14.7%; = 0.95), respectively. Over the 24 months, the mean treatment coverage for the azithromycin and placebo was 76.9% and 74.8%, respectively ( = 0.49). Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in and isolates over 24 months of follow-up.

摘要

该研究表明,给学龄前儿童每半年使用一次单剂量阿奇霉素可以降低死亡率。我们试图评估其对阿奇霉素耐药性的影响。在坦桑尼亚基利萨区的 30 个随机选择的社区中,将这些社区随机分为接受每 6 个月一次的单剂量阿奇霉素(约 20mg/kg)治疗或安慰剂治疗的两组,两组的治疗对象为 1-59 月龄的儿童。从每个社区中,以基线、12 个月和 24 个月为时间点,分别随机选择 40 名(1-59 月龄)儿童。使用鼻咽和直肠拭子分别分离和检测 和 ,并使用圆盘扩散法评估其耐药性。使用圆盘扩散法评估阿奇霉素耐药分离株的携带率和比例。在基线时,随机选择的儿童的治疗组之间的特征相似。在基线和年度横断面研究中,两组之间的治疗对象的 和 分离率相似。在基线、12 个月和 24 个月时,阿奇霉素治疗组和安慰剂治疗组儿童的阿奇霉素耐药 分离株比例分别为 26.5%(18.1%; = 0.26)、26.8%(16.5%; = 0.29)和 13.4%(17.0%; = 0.57)。阿奇霉素治疗组和安慰剂治疗组的基线、12 个月和 24 个月的阿奇霉素耐药 分离株比例分别为 14.9%(18.9%; = 0.16)、21.5%(16.6%; = 0.10)和 14.9%(14.7%; = 0.95)。在 24 个月期间,阿奇霉素和安慰剂的平均治疗覆盖率分别为 76.9%和 74.8%( = 0.49)。在 24 个月的随访中,每半年给儿童使用一次单剂量阿奇霉素,似乎并未导致 和 分离株产生过多的阿奇霉素耐药性。

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