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.
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.
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.
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.
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).
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.
與中耳通氣管(grommet, vetilation tube)相關之耳漏的處置
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
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
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌