Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years
Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years
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DOI：
10.1136/bmj.320.7231.350
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发表时间：
2000-02-05
影响因子：
--
通讯作者：
de Melker, RA
中科院分区：
文献类型：
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作者：
Damoiseaux, RAMJ;van Balen, FAM;de Melker, RA
目的探讨抗生素治疗6个月~2岁儿童急性中耳炎的疗效。设计基于临床实践的双盲、随机、安慰剂对照试验。在荷兰设立53个全科医生。240名6个月~2岁的急性中耳炎患儿接受阿莫西林40 mg/kg/d 3种剂量的干预治疗。主要结果是在第4天持续症状和/或发热、疼痛或哭闹的持续时间。结果阿莫西林组在第4天的持续性症状较少见(风险差异为13%；95%可信区间为1%至25%)。阿莫西林组的中位发热持续时间为2天，而安慰剂组为3天(P=0.004)。在疼痛和哭闹持续时间方面，安慰剂组差异无统计学意义，但前10天安慰剂组的止痛药用量较高(4.1v2.3剂，P=0.004)。此外，两组在第4天和第11天的耳镜检查结果没有差异，6周时两组的鼓室导纳结果相似。结论7~8名6~24个月的儿童急性中耳炎需要在第4天使用抗生素治疗，以改善症状转归。这种温和的效果不能证明在第一次就诊时开抗生素是合理的，前提是可以保证进行密切的监测。
Objective To determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age.Design Practice based, double blind, randomised, placebo controlled trial.Setting 53 general practices in the Netherlands.Subjects 240 children aged 6 months to 2 years with the diagnosis of acute otitis media.Intervention Amoxicillin 40 mg/kg/day in three doses.Main outcome measures Persistent symptoms at day four and duration of fever and pain or crying, or both. Otoscopy at days four and 11, tympanometry at six weeks, and use of analgesic.Results Persistent symptoms at day four were less common in the amoxicillin group (risk difference 13%; 95% confidence interval 1% to 25%). The median duration of fever was two days in the amoxicillin group versus three in die placebo group (P = 0.004). No significant difference was observed in duration of pain or crying, but analgesic consumption was higher in the placebo group during the first 10 days (4.1 v 2.3 doses, P = 0.004). In addition, no otoscopic differences were observed at days four and 11, and tympanometric findings at six weeks were similar in both groups.Conclusions Seven to eight children aged 6 to 24 months with acute otitis media needed to be treated with antibiotics to improve symptomatic outcome at day four in one child. This modest effect does not justify prescription of antibiotics at the first visit, provided close surveillance can be guaranteed.