大规模发放阿奇霉素后儿童死亡率：尼日尔 PRET 集群随机试验的二次分析。
Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of the PRET Cluster-randomized Trial in Niger.
机构信息
From the Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.
Programme FSS/Université Abdou Moumouni de Niamey, Programme National de Santé Oculaire, Niamey, Niger.
出版信息
Pediatr Infect Dis J. 2018 Nov;37(11):1082-1086. doi: 10.1097/INF.0000000000001992.
BACKGROUND
Mass distributions of azithromycin for trachoma have been associated with secondary benefits, including reductions in child mortality.
METHODS
In the Partnership for the Rapid Elimination of Trachoma cluster-randomized trial in Niger, 24 communities were randomized to annual treatment of everyone and 24 communities were randomized to biannual treatment of children under 12 for 3 years (clinicaltrials.gov, NCT00792922). Treatment was a single dose of directly observed oral azithromycin (20 mg/kg up to 1 g in adults). Vital status was assessed during annual census and monitoring visits. In this prespecified secondary analysis, we compared the mortality rate among children 6 months to less than 5 years of age by treatment arm using negative binomial regression.
RESULTS
Among children 6 months to less than 5 years of age, 404 deaths occurred during the study period. The mortality rate was 35.6 deaths per 1000 person-years (231 deaths, 95% CI: 30.9-40.9) in the annual arm and 29.0 deaths per 1000 person-years (173 deaths, 95% CI: 24.8-33.8) in the biannual arm. The mortality rate ratio comparing children in the biannual arm to the annual arm was 0.81 (95% CI: 0.66-1.00, P = 0.07; primary outcome). The mortality rate ratio comparing children who died from infectious causes in the biannual arm to the annual arm was 0.73 (95% CI: 0.57-0.94; P = 0.02). No adverse events were reported.
CONCLUSIONS
This secondary analysis of a cluster-randomized trial found a nonsignificant 19% decrease in mortality among children 6 months to less than 5 years of age who received biannual azithromycin compared with children who received annual azithromycin. This study was conducted in a high mortality, trachoma-endemic area; thus, results may be specific to this environment only. In addition, the trial was neither designed nor powered to detect a mortality effect, and we cannot rule out the possibility that mortality differences resulted from bias.
背景
大规模使用阿奇霉素治疗沙眼与次要益处相关，包括降低儿童死亡率。
方法
在尼日尔的快速消除沙眼伙伴关系集群随机试验中，24 个社区被随机分为每年对所有人进行治疗，24 个社区被随机分为每两年对 12 岁以下儿童进行治疗，持续 3 年（clinicaltrials.gov，NCT00792922）。治疗方法是单次口服阿奇霉素（成人 20mg/kg，最大剂量 1g）。在每年的人口普查和监测访问期间评估生命状态。在这项预先指定的次要分析中，我们使用负二项回归比较了治疗组 6 个月至不到 5 岁儿童的死亡率。
结果
在研究期间，6 个月至不到 5 岁的儿童中发生了 404 例死亡。在每年治疗组中，死亡率为每 1000 人年 35.6 例死亡（231 例死亡，95%CI：30.9-40.9），在每两年治疗组中，死亡率为每 1000 人年 29.0 例死亡（173 例死亡，95%CI：24.8-33.8）。与每年治疗组相比，每两年治疗组儿童的死亡率比值为 0.81（95%CI：0.66-1.00，P=0.07；主要结局）。与每年治疗组相比，每两年治疗组死于感染性疾病的儿童的死亡率比值为 0.73（95%CI：0.57-0.94；P=0.02）。没有报告不良事件。
结论
这项集群随机试验的二次分析发现，与每年接受阿奇霉素治疗的儿童相比，每两年接受阿奇霉素治疗的 6 个月至不到 5 岁儿童的死亡率降低了 19%，但无统计学意义。这项研究是在高死亡率、沙眼流行地区进行的；因此，结果可能仅适用于这种环境。此外，该试验既不是为了检测死亡率效应而设计的，也没有为此提供足够的效力，我们不能排除死亡率差异是由偏倚引起的可能性。
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