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针对沙眼的靶向抗生素:一项集群随机试验。

Targeted Antibiotics for Trachoma: A Cluster-Randomized Trial.

机构信息

Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.

The Carter Center Ethiopia, Addis Ababa, Ethiopia.

出版信息

Clin Infect Dis. 2021 Sep 15;73(6):979-986. doi: 10.1093/cid/ciab193.

Abstract

BACKGROUND

Current guidelines recommend community-wide mass azithromycin for trachoma, but a targeted treatment strategy could reduce the volume of antibiotics required.

METHODS

In total, 48 Ethiopian communities were randomized to mass, targeted, or delayed azithromycin distributions. In the targeted arm, only children aged 6 months to 5 years with evidence of ocular chlamydia received azithromycin, distributed thrice over the following year. The primary outcome was ocular chlamydia at months 12 and 24, comparing the targeted and delayed arms (0-5 year-olds, superiority analysis) and the targeted and mass azithromycin arms (8-12 year-olds, noninferiority analysis, 10% noninferiority margin).

RESULTS

At baseline, the mean prevalence of ocular chlamydia in the 3 arms ranged from 7% to 9% among 0-5 year-olds and from 3% to 9% among 8-12 year-olds. Averaged across months 12-24, the mean prevalence of ocular chlamydia among 0-5 year-olds was 16.7% (95% confidence interval [CI]: 9.0%-24.4%) in the targeted arm and 22.3% (95% CI: 11.1%-33.6%) in the delayed arm (P = .61). The final mean prevalence of ocular chlamydia among 8-12 year-olds was 13.5% (95% CI: 7.9%-19.1%) in the targeted arm and 5.5% (95% CI: 0.3%-10.7%) in the mass treatment arm (adjusted risk difference 8.5 percentage points [pp] higher in the targeted arm, 95% CI: 0.9 pp-16.1 pp higher).

CONCLUSIONS

Antibiotic treatments targeted to infected preschool children did not result in significantly less ocular chlamydia infections compared with untreated communities and did not meet noninferiority criteria relative to mass azithromycin distributions. Targeted approaches may require treatment of a broader segment of the population in areas with hyperendemic trachoma.

摘要

背景

目前的指南建议在社区范围内大规模使用阿奇霉素治疗沙眼,但靶向治疗策略可以减少所需抗生素的数量。

方法

共有 48 个埃塞俄比亚社区被随机分为大规模、靶向或延迟阿奇霉素分布组。在靶向组中,只有 6 个月至 5 岁有眼部衣原体感染证据的儿童接受阿奇霉素治疗,在接下来的一年中分三次给药。主要结局是比较靶向和延迟组(0-5 岁儿童,优效性分析)以及靶向和大规模阿奇霉素组(8-12 岁儿童,非劣效性分析,10%非劣效性边界)在 12 个月和 24 个月时的眼部衣原体。

结果

在基线时,3 个组中 0-5 岁儿童的眼部衣原体平均患病率在 7%至 9%之间,8-12 岁儿童的眼部衣原体平均患病率在 3%至 9%之间。在 12-24 个月期间,0-5 岁儿童的眼部衣原体平均患病率在靶向组中为 16.7%(95%置信区间[CI]:9.0%-24.4%),在延迟组中为 22.3%(95% CI:11.1%-33.6%)(P=0.61)。在靶向组中,8-12 岁儿童的最终眼部衣原体平均患病率为 13.5%(95% CI:7.9%-19.1%),在大规模治疗组中为 5.5%(95% CI:0.3%-10.7%)(调整后的风险差异为靶向组高 8.5 个百分点[95%CI:0.9 个百分点至 16.1 个百分点])。

结论

针对感染学龄前儿童的抗生素治疗并未导致眼部衣原体感染明显减少,与未治疗社区相比,也未达到非劣效性标准,与大规模阿奇霉素分布相比。在沙眼高度流行地区,靶向方法可能需要对更广泛的人群进行治疗。

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