Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.
Department of Ophthalmology, University of California, San Francisco, San Francisco, California, United States of America.
PLoS Negl Trop Dis. 2018 Nov 12;12(11):e0006950. doi: 10.1371/journal.pntd.0006950. eCollection 2018 Nov.
Mass azithromycin distribution reduces under-5 child mortality. Trachoma control programs currently treat infants aged 6 months and older. Here, we report findings from an infant adverse event survey in 1-5 month olds who received azithromycin as part of a large community-randomized trial in Niger.
Active surveillance of infants aged 1-5 months at the time of treatment was conducted in 30 randomly selected communities from within a large cluster randomized trial of biannual mass azithromycin distribution compared to placebo to assess the potential impact on child mortality. We compared the distribution of adverse events reported after treatment among azithromycin-treated versus placebo-treated infants. From January 2015 to February 2018, the caregivers of 1,712 infants were surveyed. Approximately one-third of caregivers reported at least one adverse event (azithromycin: 29.6%, placebo: 34.3%, risk ratio [RR] 0.86, 95% confidence interval [CI] 0.68 to 1.10, P = 0.23). The most commonly reported adverse events included diarrhea (azithromycin: 19.3%, placebo: 28.1%, RR 0.68, 95% CI 0.49 to 0.96, P = 0.03), vomiting (azithromycin: 15.9%, placebo: 21.0%, RR 0.76, 95% CI 0.56 to 1.02, P = 0.07), and skin rash (azithromycin: 12.3%, placebo: 13.6%, RR 0.90, 95% CI 0.59 to 1.37, P = 0.63). No cases of infantile hypertrophic pyloric stenosis were reported.
Azithromycin given to infants aged 1-5 months appeared to be safe. Inclusion of younger infants in larger azithromycin-based child mortality or trachoma control programs could be considered if deemed effective.
ClinicalTrials.gov NCT02048007.
大规模使用阿奇霉素可以降低五岁以下儿童的死亡率。目前，沙眼控制项目针对的是 6 个月及以上的婴儿。在这里，我们报告了在尼日尔进行的一项大规模社区随机试验中，对 1-5 个月大的婴儿使用阿奇霉素进行治疗的不良反应调查结果。
在这项针对 1-5 个月大婴儿的治疗期间进行了主动监测，该监测是在大规模的两年一次大规模阿奇霉素分发与安慰剂对照的随机临床试验中，在 30 个随机选定的社区内进行的，以评估其对儿童死亡率的潜在影响。我们比较了接受阿奇霉素治疗和接受安慰剂治疗的婴儿报告的不良反应分布情况。从 2015 年 1 月至 2018 年 2 月，对 1712 名婴儿的照顾者进行了调查。约有三分之一的照顾者报告了至少一种不良反应（阿奇霉素组：29.6%，安慰剂组：34.3%，风险比 [RR]0.86，95%置信区间 [CI]0.68 至 1.10，P=0.23）。最常见的不良反应包括腹泻（阿奇霉素组：19.3%，安慰剂组：28.1%，RR0.68，95%置信区间 [CI]0.49 至 0.96，P=0.03）、呕吐（阿奇霉素组：15.9%，安慰剂组：21.0%，RR0.76，95%置信区间 [CI]0.56 至 1.02，P=0.07）和皮疹（阿奇霉素组：12.3%，安慰剂组：13.6%，RR0.90，95%置信区间 [CI]0.59 至 1.37，P=0.63）。没有报告婴儿肥厚性幽门狭窄的病例。
给 1-5 个月大的婴儿使用阿奇霉素似乎是安全的。如果认为有效，可以考虑将年龄更小的婴儿纳入更大规模的基于阿奇霉素的儿童死亡率或沙眼控制项目中。
ClinicalTrials.gov NCT02048007。
