Topical antibiotics without steroids for chronically discharging ears with underlying eardrum perforations

  • Review
  • Intervention

Authors


Abstract

Background

Chronic suppurative otitis media (CSOM) causes ear discharge and impairs hearing.

Objectives

Assess topical antibiotics (excluding steroids) for treating chronically discharging ears with underlying eardrum perforations (CSOM).

Search methods

The Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 1, 2005), MEDLINE (January 1951 to March 2005), EMBASE (January 1974 to March 2005), LILACS (January 1982 to March 2005), AMED (1985 to March 2005), CINAHL (January 1982 to March 2005), OLDMEDLINE (January 1958 to December 1965), PREMEDLINE, metaRegister of Controlled Trials (mRCT), and article references.

Selection criteria

Randomised controlled trials; any topical antibiotic without steroids, versus no drug treatment, aural toilet, topical antiseptics, or other topical antibiotics excluding steroids; participants with CSOM.

Data collection and analysis

One author assessed eligibility and quality, extracted data, entered data onto RevMan; two authors inputted where there was ambiguity. We contacted investigators for clarifications.

Main results

Fourteen trials (1,724 analysed participants or ears). CSOM definitions and severity varied; some included otitis externa, mastoid cavity infections and other diagnoses. Methodological quality varied; generally poorly reported, follow-up usually short, handling of bilateral disease inconsistent. Topical quinolone antibiotics were better than no drug treatment at clearing discharge at one week: relative risk (RR) was 0.45 (95% confidence interval (CI) 0.34 to 0.59) (two trials, N = 197). No statistically significant difference was found between quinolone and non-quinolone antibiotics (without steroids) at weeks one or three: pooled RR were 0.89 (95% CI 0.59 to 1.32) (three trials, N = 402), and 0.97 (0.54 to 1.72) (two trials, N = 77), respectively. A positive trend in favour of quinolones seen at two weeks was largely due to one trial and not significant after accounting for heterogeneity: pooled RR 0.65 (0.46 to 0.92) (four trials, N = 276) using the fixed-effect model, and 0.64 (95% CI 0.35 to 1.17) accounting for heterogeneity with the random-effects model. Topical quinolones were significantly better at curing CSOM than antiseptics: RR 0.52 (95% CI 0.41 to 0.67) at one week (three trials, N = 263), and 0.58 (0.47 to 0.72) at two to four weeks (four trials, N = 519). Meanwhile, non-quinolone antibiotics (without steroids) compared to antiseptics were more mixed, changing over time (four trials, N = 254). Evidence regarding safety was generally weak.

Authors' conclusions

Topical quinolone antibiotics can clear aural discharge better than no drug treatment or topical antiseptics; non-quinolone antibiotic effects (without steroids) versus no drug or antiseptics are less clear. Studies were also inconclusive regarding any differences between quinolone and non-quinolone antibiotics, although indirect comparisons suggest a benefit of topical quinolones cannot be ruled out. Further trials should clarify non-quinolone antibiotic effects, assess longer-term outcomes (for resolution, healing, hearing, or complications) and include further safety assessments, particularly to clarify the risks of ototoxicity and whether quinolones may result in fewer adverse events than other topical treatments.

摘要

背景

不含類固醇之局部抗生素耳滴劑治療鼓膜穿孔之慢性耳漏

慢性化膿性中耳炎(CSOM)造成耳漏及聽力受損

目標

評估局部抗生素耳滴劑(不含類固醇)治療鼓膜穿孔之慢性耳漏(CSOM)

搜尋策略

搜尋Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 1, 2005), MEDLINE (January 1951 to March 2005), EMBASE (January 1974 to March 2005), LILACS (January 1982 to March 2005), AMED (1985 to March 2005), CINAHL (January 1982 to March 2005), OLDMEDLINE (January 1958 to December 1965), PREMEDLINE, metaRegister of Controlled Trials (mRCT),及文章之參考文獻

選擇標準

隨機對照試驗,比較所有不含類固醇之局部抗生素耳滴劑與無藥物治療、耳部清理、局部抗菌劑、或其他種類之不含類固醇的局部抗生素耳滴劑,參與者是慢性化膿性中耳炎患者

資料收集與分析

一位作者評估研究的資格及品質,摘選資料並輸入至RevMan,對於不明確的資料,由兩位作者輸入。我們聯繫實驗作者以得清楚的資訊

主要結論

共14個試驗(分析1724位參與者或耳朵)。研究中慢性化膿性中耳炎定義及嚴重度各不相同,有些包括外耳炎、乳突腔感染、及其他診斷。研究的設計方法品質也不同,多數屬於設計不良、追蹤期通常很短、處理雙耳疾病方式不統一。在治療一星期後耳漏被清乾淨的情形,局部quinolone類抗生素比無藥物治療好,相對風險(RR)為0.45 (95%信賴區間(CI) 0.34 – 0.59) (兩個試驗, N = 197)。在治療一星期或三星期後的情形,用局部quinolone類抗生素或非quinolone類抗生素(不含類固醇)之間無統計學上明顯差異:整合資料之相對風險分別為0.89 (95% CI 0.59 – 1.32)(三個試驗, N = 402)及0.97 (0.54 – 1.72)(兩個試驗, N = 77)。在治療兩週後的偏向quinolones效果較好是來自於一個試驗的結果,如果根據異質性分析後則無明顯差別:整合資料用固定效應模式分析的相對風險為0.65 (0.46 – 0.92)(四個試驗, N = 276),用隨機效應模式分析其異質性則為0.64 (95% CI 0.35 – 1.17)。在治癒慢性化膿性中耳炎方面,局部quinolones明顯優於抗菌劑:相對風險在治療一周後為0.52 (95% CI 0.41 – 0.67)(三個試驗, N = 263),治療二至四周後為0.58 (0.47 – 0.72)(四個試驗, N = 519)。非quinolone類抗生素(不含類固醇)與抗菌劑比較的結果則較不一致,會隨時間改變(四個試驗, N = 254)。關於安全性的證據較弱

作者結論

局部quinolone類抗生素耳滴劑比無藥物治療或局部抗菌劑較能清除耳部分泌物;而比較非quinolone類抗生素(不含類固醇)的作用對無藥物或抗菌劑,效果較不明確。關於比較quinolone類與非quinolone類抗生素之間的研究,結論也不明確,但間接的比較顯示不能否定局部quinolone之利益。將來的試驗需要說明非quinolone類抗生素之效果,評估長期結果(關於緩解、癒合、聽力、或併發症),並包括之後的安全性評估,尤其需闡明耳毒性的風險,及是否quinolone的不良作用會比其他局部治療要少

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

這是一篇 Cochrane系統性回顧,在任何年紀之參與者中評估不含類固醇之局部抗生素耳滴劑來治療鼓膜穿孔之慢性耳漏。慢性化膿性中耳炎(CSOM)是中耳腔有化膿性感染且鼓膜有持續性穿孔,這是個可預防的聽力受損常見原因,尤其在中低收入之鄉村。這篇回顧在評估局部抗生素(不含類固醇)耳滴劑,來闡明其是否優於無治療或耳部清理(清除耳分泌物)、或局部抗菌劑治療,並確認何類抗生素最佳。共14個隨機對照試驗(分析1724位參與者或耳朵),多數屬於設計不良,且有些研究包含的診斷很廣泛。在使耳部乾燥方面,Quinolone類抗生素耳滴劑(被認為是局部抗生素之“黃金標準”)優於無藥物治療或抗菌劑。至於非Quinolone類抗生素耳滴劑(不含類固醇)與抗菌劑比較時,其效果較不明顯。關於比較quinolone類與非quinolone類抗生素之間的研究,也無明確結論,但間接證據顯示不能否定局部quinolone之利益。長期追蹤的結果(長期保有乾耳、預防併發症、使鼓膜癒合、及改善聽力)或關於治療有併發症的慢性化膿性中耳炎這兩方面訊息較少。這些試驗中關於安全性的證據也較弱。須要更多研究來評估是否局部quinolone所造成的不良作用會比其他局部治療少

Plain language summary

A Cochrane systematic review assessing topical antibiotics without steroids for treating chronically discharging ears with underlying eardrum perforations, in participants of any age

Chronic suppurative otitis media (CSOM) is an infection of the middle ear with pus and a persistent perforation in the eardrum. It is a common cause of preventable hearing impairment, particularly in low and middle-income countries. This review assesses topical antibiotics (without steroids), to clarify whether they are better than no treatment or aural toilet (cleaning of the ear discharge), or treatment with topical antiseptics and to identify which antibiotic is best. Fourteen randomised controlled trials were included (1,724 analysed participants or ears); most were poorly reported, and some included a range of diagnoses.

Quinolone antibiotic drops (considered to be the 'gold standard' topical antibiotics) are better than no drug treatment or antiseptics at drying the ear. The effects of non-quinolone antibiotics (without steroids) when compared to antiseptics are less clear. Studies were also inconclusive regarding any differences between quinolone and non-quinolone antibiotics, although indirect evidence suggests a benefit of quinolones cannot be ruled out. Less is known about longer-term outcomes (producing a dry ear in the long term, preventing complications, healing the eardrum, and improving hearing), or about treating complicated CSOM. The evidence in these trials about safety is also weak. More research is needed to assess whether there may be fewer adverse events with topical quinolones than with alternative topical treatments.

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