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Interventions for ear discharge associated with grommets (ventilation tubes)

  • Review
  • Intervention

Authors


Abstract

Background

The insertion of grommets (also known as ventilation or tympanostomy tubes) is one of the most common surgical procedures performed on children. Postoperative otorrhoea (discharge) is the most common complication with a reported incidence ranging from 10% to 50%. In the UK, many ENT surgeons treat with topical antibiotics/steroid combinations, but general practitioners, mainly through fears of ototoxicity, are unlikely to prescribe these and choose systemic broad-spectrum antibiotics.

Objectives

1. To identify the most effective non-surgical management of discharge from ears with grommets in place.
2. To identify the risks of non-surgical management for this condition (e.g. ototoxicity), and to set benefits of treatment against these risks.

Search methods

We searched the Cochrane Ear, Nose and Throat Disorders Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2005), MEDLINE (1966 to 2005) and EMBASE (1974 to 2005). We also searched the CINAHL, AMED, LILACS, ISI WEB OF KNOWLEDGE, ISI PROCEEDINGS, mRCT, NNR, ZETOC, KOREAMED, CSA, MEDCARIB, INDMED and SAMED databases. The date of the last search was February 2005.

Selection criteria

Randomised controlled trials of adults or children, with any type of grommet and an ear with discharge were included. The trials compared treatment with placebo or one treatment with another. The primary outcome measure was the duration of the discharge.

Data collection and analysis

The trials were selected independently according to the above criteria by the four reviewers. Differences in opinion over the inclusion of studies were resolved by discussion. The studies were graded using the CASP critical appraisal tool. Analyses were based on the presence of discharge seven days from the onset of treatment.

Main results

There was very little good quality evidence. Four studies were included, all of them investigating different interventions and therefore a meta-analysis was not possible.

Only one study demonstrated a significant difference. Oral amoxicillin clavulanate was compared to placebo in 79 patients. The odds of having a discharge persisting eight days after starting treatment was 0.19 (95% CI 0.07 to 0.49) . The number needed to treat to achieve that benefit is 2.5. Participants in both arms of this study also received daily aural toilet. The results will therefore not be applicable to most settings including primary care.

No significant benefit was shown in the two studies investigating steroids (oral prednisolone with oral amoxicillin clavulanate and topical dexamethasone with topical ciprofloxacin ear drops), or the one study comparing an antibiotic-steroid combination (Otosporin®) drops versus spray (Otomize®) (although more patients preferred the spray form).

Authors' conclusions

The authors of this review have been unable to identify the most effective intervention or to assess the associated risks. Research is urgently needed into the effectiveness of oral versus topical antibiotics in this group of patients. Clinicians considering antibiotic treatment need to balance any potential benefit against the risks of side effects and antibiotic resistance.

摘要

背景

與中耳通氣管(grommet, vetilation tube)相關之耳漏的處置

置入中耳通氣管是兒童最常見的手術之ㄧ,而術後耳漏是最常見的併發症,發生率約10%到50%。在英國,許多耳鼻喉科醫師用抗生素/類固醇複方耳滴劑治療,但由於擔心其耳毒性,一般醫師捨棄此種耳滴劑而選擇全身性的廣效抗生素

目標

1.確認最有效的非手術方式來治療中耳通氣管所引起的耳漏。2.找出用非手術方式治療此種情況所造成的風險(例如:耳毒性),並且確認其治療的優點多於其風險

搜尋策略

搜尋了Cochrane Ear,Nose and Throat Disorders Group Specialised Register,Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library,Issue 1, 2005),MEDLINE (1966 to 2005)及EMBASE (1974 to 2005).也搜尋了CINAHL,AMED,LILACS,ISI WEB OF KNOWLEDGE,ISI PROCEEDINGS,mRCT,NNR,ZETOC,KOREAMED,CSA,MEDCARIB,INDMED及SAMED資料庫。最後搜尋日期為2005年2月

選擇標準

收集了大人或小孩裝有任何種類之中耳通氣管且一耳有耳漏之隨機對照試驗,這些試驗比較了用安慰劑治療及其他方式治療,主要的結果評量標準為耳漏的時間

資料收集與分析

這些研究分別由四位評論者依上述標準所選出,對於這些研究的不同意見已在討論後解決。這些研究用CASP評價方法來分級。分析出現耳漏而開始治療後,症狀仍持續7天者

主要結論

收集的研究中有優質的證據性者很少。收集的4個研究分別探討不同的處理方式,於是無法作統合分析。只有一個研究顯示有明顯差異,其在79個病人中比較口服amoxicillin clavulanate與安慰劑,開始治療後耳漏仍持續8天的勝算(odds)為0.19(95% CI 0.07 to 0.49),要達到此種明顯治療效果的治療次數為2.5次,因為此研究的所有病患都接受了每天一次的局部治療,於是大部分醫療單位,包含基層醫療,不一定能適用此研究的結果。兩個研究比較類固醇(口服prednisolone 對口服amoxicillin clavulanate,及局部dexamethasone耳滴劑對局部ciprofloxacin耳滴劑),一個研究比較抗生素/類固醇複方耳滴劑(Otosporin?) 對噴劑 (Otomize?)(多數病患偏好噴劑)皆顯示無明顯治療效果

作者結論

此篇評論的作者們無法確認最有效的處置方式或評估其相關風險。我們急需要比較用口服或局部抗生素治療此類病患的效果的研究。考慮用抗生素治療的醫師須平衡其潛在利益及副作用的風險,及抗生素抗藥性問題

翻譯人

本摘要由國泰綜合醫院方德詠翻譯

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

總結

針對置入中耳通氣管後耳漏的病患,需有更多研究來找出最有效的治療方法。置入中耳通氣管於鼓膜上主要用在膠狀中耳積液或反覆中耳炎的兒童(及成人),耳漏是中耳通氣管常見的併發症,會造成兒童不舒適及再次降低聽力。兩個主要處理為口服抗生素或抗生素耳滴劑,但沒有足夠的證據顯示何者最有效或其副作用。到目前只有一個研究顯示口服抗生素有效

Plain language summary

Interventions for ear discharge associated with grommets (ventilation tubes)

More research is needed to find the most effective treatment for discharge from ears in patients who have had grommets fitted.

Inserting grommets (ventilation or tympanostomy tubes) into the ear drum is commonly used for children (and adults) with glue ear or recurrent ear infections. Ear discharge is a common complication of having grommets in the ear. This is unpleasant for the child and reduces their hearing again.

The two main interventions are antibiotics given by mouth or as ear drops. There is not enough evidence about which is most effective or about side effects. Only one antibiotic given by mouth has so far been shown to be effective.

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