Instituto de Atención Pediátrica, PO Box 607-1150, La Uruca, San José, Costa Rica.
Int J Infect Dis. 2011 Apr;15(4):e240-8. doi: 10.1016/j.ijid.2010.12.003. Epub 2011 Jan 26.
A randomized, double-blind, double-dummy, multicenter international study was conducted to assess the clinical and bacteriologic response, safety, and compliance of a single 60-mg/kg dose of azithromycin extended-release (ER) versus a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in children with acute otitis media at high risk of persistent or recurrent middle ear infection.
Children aged 3 to 48 months were enrolled and stratified into two age groups (≤ 24 months and >24 months). Pretreatment tympanocentesis was performed at all sites and was repeated during treatment at selected sites.
The primary endpoint, clinical response at the test-of-cure visit in the bacteriologic eligible population, was achieved in 80.5% of children in the azithromycin ER group and 84.5% of children in the amoxicillin/clavulanate group (difference-3.9%; 95% confidence interval-10.4, 2.6). Bacteriologic eradication was 82.6% in the azithromycin ER group and 92% in the amoxicillin/clavulanate group (p=0.050). Children who received amoxicillin/clavulanate had significantly higher rates of dermatitis and diarrhea, a greater burden of adverse events, and a lower rate of compliance to study drug compared to those who received azithromycin ER.
A single 60-mg/kg dose of azithromycin ER provides near equivalent effectiveness to a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in the treatment of children with acute otitis media.
一项随机、双盲、双模拟、多中心国际研究旨在评估阿奇霉素缓释（ER）单次 60mg/kg 剂量与阿莫西林/克拉维酸 90/6.4mg/kg 每日 10 天方案在高风险持续性或复发性中耳炎的儿童中的临床和细菌学反应、安全性和依从性。
招募年龄为 3 至 48 个月的儿童，并分为两个年龄组（≤24 个月和>24 个月）。所有部位均进行治疗前鼓膜穿刺术，并在选定部位的治疗期间重复进行。
主要终点，细菌学合格人群的治愈期临床反应，阿奇霉素 ER 组 80.5%的儿童和阿莫西林/克拉维酸组 84.5%的儿童达到（差异-3.9%；95%置信区间-10.4，2.6）。阿奇霉素 ER 组的细菌清除率为 82.6%，阿莫西林/克拉维酸组为 92%（p=0.050）。与接受阿奇霉素 ER 的儿童相比，接受阿莫西林/克拉维酸的儿童的皮疹和腹泻发生率更高，不良事件负担更大，以及对研究药物的依从性较低。
单次 60mg/kg 剂量的阿奇霉素 ER 与阿莫西林/克拉维酸 90/6.4mg/kg 每日 10 天方案在治疗儿童急性中耳炎方面具有相当的疗效。
