A Placebo-Controlled Trial of Antimicrobial Treatment for Acute Otitis Media
A Placebo-Controlled Trial of Antimicrobial Treatment for Acute Otitis Media
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DOI：
10.1056/nejmoa1007174
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发表时间：
2011-01-13
影响因子：
158.5
通讯作者：
Ruohola, Aino
中科院分区：
文献类型：
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作者：
Tahtinen, Paula A.;Laine, Miia K.;Ruohola, Aino
在这个随机的，双盲试验中，儿童6至35个月的年龄与急性中耳炎，诊断与使用严格的标准，阿莫西林-克拉维酸（161名儿童）或安慰剂（158名儿童）7天的抗菌治疗儿童急性中耳炎的疗效仍然存在争议。主要结局是从首次给药至第8天治疗结束访视的至治疗失败时间。治疗失败的定义是基于儿童的总体状况（包括不良事件）和急性中耳炎的耳镜体征。阿莫西林-克拉维酸治疗失败的发生率为18.6%，而安慰剂组为44.9%（P
BACKGROUNDThe efficacy of antimicrobial treatment in children with acute otitis media remains controversial.METHODSIn this randomized, double-blind trial, children 6 to 35 months of age with acute otitis media, diagnosed with the use of strict criteria, received amoxicillin-clavulanate (161 children) or placebo (158 children) for 7 days. The primary outcome was the time to treatment failure from the first dose until the end-of-treatment visit on day 8. The definition of treatment failure was based on the overall condition of the child (including adverse events) and otoscopic signs of acute otitis media.RESULTSTreatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, as compared with 44.9% of the children who received placebo (P