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Antibiotics for acute otitis media in children

  • Review
  • Intervention




Acute otitis media (AOM) is one of the most common diseases in early infancy and childhood. Antibiotic use for AOM varies from 56% in the Netherlands to 95% in the USA and Australia.


To assess the effects of antibiotics for children with AOM.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2008, issue 2) which contains the Acute Respiratory Infections (ARI) Group's Specialized Register; MEDLINE (1966 to June week 4 2008); OLDMEDLINE (1958 to 1965); EMBASE (January 1990 to July 2008); and Current Contents (1966 to July 2008).

Selection criteria

Randomised controlled trials comparing 1) antimicrobial drugs with placebo 2) immediate antibiotic treatment with observational treatment approaches in children with AOM.

Data collection and analysis

Three review authors independently assessed trial quality and extracted data.

Main results

We found 10 trials (2928 children) from high income countries with low risk of bias. Pain was not reduced by antibiotics at 24 hours, but was at two to seven days, (relative risk (RR) 0.72; 95% confidence interval 0.62 to 0.83). However four trials (1271 children) comparing antibiotics prescribed immediately rather than initial observation found no difference at three to seven days. Antibiotics did not reduce tympanometry, perforation or recurrence. The only case of mastoiditis was in an antibiotic treated child. Vomiting, diarrhoea or rash was higher in children taking antibiotics (RR 1.37; 95% CI 1.09 to 1.76). Individual patient data meta-analysis of a subset of the included trials found antibiotics to be most beneficial in children: aged less than two; with bilateral AOM and with both AOM and otorrhoea.

Authors' conclusions

Antibiotics slightly reduce the number of children with acute middle ear infection experiencing pain after a few days. However, most (78%) settle spontaneously in this time, meaning 16 children must be treated to prevent one suffering ear pain. This benefit must be weighed against the possible harms: 1 in 24 children experience symptoms caused by antibiotics. Antibiotics are most useful in children under two years of age, with bilateral AOM, and with both AOM and discharging ears. For most other children with mild disease, an expectant observational approach seems justified. We have no data on populations with higher risks of complications.



抗生素治療兒童急性中耳炎(acute otitis media)





我們檢索了Cochrane Central Register of Controlled Trials (CENTRAL)(Cochrane圖書館2008年第2期),其中包括Acute Respiratory Infection Group's Specialized Registe、MEDLINE(1966年至2008年6月第4週)、OLDMEDLINE(1958年至1965年)、EMBASE(1990年1月至2008年7月),以及Current Contents(1966年至2008年7月)。






我們找到了10個試驗、共2928位兒童,他們皆來自由高收入國家,以減少任何可能的實驗偏差。結果顯示,使用抗生素的前24小時內並無法減少疼痛的情形,但在第2至7天後能有所改善(RR 0.72,95%CI 0.70 �0.74);而其中4個試驗(共1271位兒童)比較了在發病後立即使用抗生素、或是採取觀察等這兩種方式,發現在第3至7天之間結果並無差別。抗生素並不能降低鼓室聽力檢查的需求性、耳膜穿孔或是疾病的復發的機率。唯一發生乳突炎(mastoiditis)的案例是一名使用抗生素治療的兒童。服用抗生素的兒童有較高的比例會產生嘔吐、腹瀉,以及皮疹(RR1.37,95%CI 1.34 �1.39)。根據病人個別資料所進行的Metaanalysis分析試驗發現,抗生素對於年齡小於兩歲、雙側急性中耳炎,以及急性中耳炎合併耳漏(otorrhoea)的病人較有幫助。





此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。


急性中耳炎在兒童相當常見,並會造成疼痛甚或耳聾。雖然急性中耳炎通常可不經治療而自行痊癒,但抗生素治療的使用仍相當普遍。這次的回顧研究發現,抗生素治療對大多數兒童急性中耳炎的幫助不大。抗生素的使用可稍微減少前24小時 (此時大多數兒童都已好轉)、以及後續幾天的疼痛,但無法減少聽力損失(可持續數週)的人數。然而,抗生素似乎對於年齡不到兩歲、雙側急性中耳炎,以及急性中耳炎合併耳漏的病人較有幫助。沒有足夠的證據顯示抗生素是否能減少其他罕見的併發症,如乳突炎。有些治療準則建議對病人採取觀察的方式,除非在經過數日的觀察後發現症狀仍持續進展時,才採用抗生素。此外,立即使用抗生素及採取觀察的兩組病人,在發病後第3至7天之間並沒有差別。在這次的回顧研究當中,所有研究對象都來自於高收入國家,而缺乏了有較高急性中耳炎及乳突炎發病率的族群資料。抗生素亦會同時造成有害的影響,如腹瀉、胃痛、皮疹,以及抗藥性的產生等等。對於大多數兒童而言,該如何衡量抗生素所帶來的小利與小害是個困難的議題。

Plain language summary

Antibiotics for reducing the pain of middle ear infection (acute otitis media) in children

Acute otitis media (AOM) is common in children, causing pain and deafness. Though AOM usually resolves without treatment, it is often treated with antibiotics. This review found that antibiotics are not very useful for most children with AOM. Antibiotics marginally decreased the number of children with pain at 24 hours (when most children were better), only slightly reduced the number of children with pain in the few days following and did not reduce the number of children with hearing loss (that can last several weeks). However, antibiotics seem to be most beneficial in children younger than two years of age with bilateral AOM (infection in both ears), and in children with both AOM and otorrhoea (discharge from the ear). There was not enough information to know if antibiotics reduced rare complications such as mastoiditis (an infection of the bones around the ear). Some guidelines have recommended a management approach in which certain children are observed and antibiotics taken only if symptoms remain or have worsened after a few days. This review found no difference between immediate antibiotics and observational treatment approaches in the number of children with pain three to seven days after assessment. All of the studies included in this review were from high-income countries. Data from populations in which the incidence of AOM and risk of progression to mastoiditis is much higher are lacking. Antibiotics caused unwanted effects such as diarrhoea, stomach pain and rash, and may also increase resistance to antibiotics in the community. It is difficult to balance the small benefits against the small harms of antibiotics for most children.