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抗生素与外用消毒剂治疗慢性化脓性中耳炎的比较

Antibiotics versus topical antiseptics for chronic suppurative otitis media.

作者信息

Head Karen, Chong Lee Yee, Bhutta Mahmood F, Daw Jessica, Veselinović Tamara, Morris Peter S, Vijayasekaran Shyan, Schilder Anne Gm, Brennan-Jones Christopher G

机构信息

Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.

Department of Global Health and Infection, Brighton & Sussex Medical School, Brighton, UK.

出版信息

Cochrane Database Syst Rev. 2025 Jun 9;6(6):CD013056. doi: 10.1002/14651858.CD013056.pub3.


DOI:10.1002/14651858.CD013056.pub3
PMID:40484400
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12145958/
Abstract

BACKGROUND: Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media, is a chronic inflammation and often polymicrobial infection of the middle ear and mastoid cavity. It is characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Antibiotics and antiseptics kill or inhibit the micro-organisms that may be responsible for the infection. Antibiotics can be applied topically or administered systemically via the oral or injection route. Antiseptics are always directly applied to the ear (topically). OBJECTIVES: To assess the benefits and harms of antibiotics versus antiseptics for people with chronic suppurative otitis media (CSOM). SEARCH METHODS: We searched the Cochrane ENT Register, CENTRAL, Ovid MEDLINE, Ovid Embase, and five other databases. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (ICTRP). The latest search date was 15 June 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) with at least a one-week follow-up involving adults and children who had chronic ear discharge of unknown cause or CSOM, where ear discharge had continued for more than two weeks. The intervention was any single, or combination of, antibiotic agent, whether applied topically (without steroids) or systemically. The comparison was any single, or combination of, topical antiseptic agent, applied as ear drops, powders, or irrigations, or as part of an aural toileting procedure. The comparisons were 1. topical antiseptics compared to topical antibiotics, and 2. topical antiseptics compared to systemic antibiotics. We further separated these comparisons into those in which a. both groups of participants received aural toileting in addition to the intervention, or b. both groups received some other add-on therapy treatment (such as systemic antibiotics) to both arms. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. Our primary outcomes were resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks; health-related quality of life using a validated instrument; and ear pain (otalgia) or discomfort or local irritation. Secondary outcomes were hearing, serious complications, and ototoxicity. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This updated review included eight new studies. Overall, we identified 15 studies (2371 participants) across seven comparisons with antibiotics compared to acetic acid, aluminium acetate, boric acid, and povidone-iodine. None of the included studies reported health-related quality of life or serious complications. 1. Topical antibiotics (quinolones or aminoglycosides) versus topical antiseptic (acetic acid) We included seven studies (835 participants). Acetic acid may increase resolution of ear discharge when compared to aminoglycoside at one to two weeks (low-certainty evidence). It is very uncertain whether acetic acid may increase resolution of ear discharge at one to two weeks when compared to topical quinolone. Results after four weeks were only presented narratively. It is very uncertain whether acetic acid may cause more ear pain, discomfort, local irritation, or combinations of these compared to topical antibiotics (aminoglycosides and quinolones) (risk ratio (RR) 0.20, 95% confidence interval (CI) 0.03 to 1.12; I = 0%; 3 studies, 277 participants; very low-certainty evidence). An additional two studies (350 participants) provided narrative results. There may be little to no difference in hearing between groups reported narratively (quinolones; low-certainty evidence). The evidence is very uncertain for serious complications (aminoglycosides) or suspected ototoxicity (aminoglycosides) (very low-certainty evidence). 2. Topical antibiotics (quinolones) versus topical antiseptic (boric acid) We included two studies (532 participants). Topical quinolones are likely to increase resolution of ear discharge at one to two weeks compared with boric acid ear drops (RR 1.86, 95% CI 1.48 to 2.35; 1 study, 411 participants; moderate-certainty evidence). This means that one additional person will have resolution of ear discharge for every four people receiving topical antibiotics (compared with boric acid) at two weeks. No study reported results for ear discharge after four weeks. There may be less ear pain, discomfort, or irritation with quinolones compared with boric acid (RR 0.56, 95% CI 0.32 to 0.98; 2 studies, 510 participants; low-certainty evidence). Suspected ototoxicity and serious complications were not reported. Topical quinolones may result in a greater improvement in mean hearing from baseline compared to topical boric acid (mean difference (MD) 2.79 decibels, 95% CI 0.48 to 5.10; 1 study, 390 participants; low-certainty evidence), but this difference may not be clinically significant. 3. Topical antibiotics (quinolones) versus topical antiseptic (povidone-iodine) We included one study (40 participants). It is very uncertain if there is a difference between quinolones and povidone-iodine with respect to resolution of ear discharge at one to two weeks (RR 1.02, 95% CI 0.82 to 1.26; 1 RCT, 39 participants; very low-certainty evidence). The study reported qualitatively that there were no differences between the groups for hearing and no participants developed ototoxic effects (very low-certainty evidence). There were no results reported for resolution of ear discharge beyond four weeks; ear pain, discomfort, or irritation; or serious complications. 4. Topical antibiotics versus topical antiseptic (aluminium acetate) We included one study (51 participants; 60 ears) that presented results for resolution of ear discharge at two to four weeks results narratively. No other results were reported. 5. Other comparisons Five studies (966 participants) were assessed over an additional three comparisons; however, these results have not been included in the abstract. AUTHORS' CONCLUSIONS: Treatment of CSOM with topical antibiotics (quinolones) likely results in an increase in resolution of ear discharge compared with boric acid at up to two weeks. There was limited evidence for the efficacy of other topical antibiotics or topical antiseptics and so we are unable to draw conclusions. Harmful effects were not well reported. Limitations of the review include lack of recent data, limitations in the quality of included studies, and limited information on certain population groups or interventions.

摘要

背景:慢性化脓性中耳炎(CSOM),有时也被称为慢性中耳炎,是一种中耳和乳突腔的慢性炎症,通常为多微生物感染。其特征是通过鼓膜穿孔出现耳漏(耳溢液)。CSOM的主要症状是耳漏和听力损失。抗生素和防腐剂可杀死或抑制可能导致感染的微生物。抗生素可局部应用,也可通过口服或注射途径全身给药。防腐剂总是直接用于耳部(局部)。 目的:评估抗生素与防腐剂治疗慢性化脓性中耳炎(CSOM)患者的利弊。 检索方法:我们检索了Cochrane耳鼻喉科注册库、CENTRAL、Ovid MEDLINE、Ovid Embase以及其他五个数据库。我们还检索了ClinicalTrials.gov和世界卫生组织国际临床试验注册平台(ICTRP)。最新检索日期为2022年6月15日。 选择标准:我们纳入了至少为期一周随访的随机对照试验(RCT),受试者为有不明原因慢性耳漏或CSOM的成人和儿童,耳漏持续时间超过两周。干预措施为任何单一抗生素或抗生素组合,无论是局部应用(不含类固醇)还是全身应用。对照为任何单一局部防腐剂或防腐剂组合,以滴耳液、粉剂或冲洗液形式应用,或作为耳道清理程序的一部分。比较内容为:1. 局部防腐剂与局部抗生素;2. 局部防腐剂与全身抗生素。我们进一步将这些比较分为:a. 两组参与者在干预之外均接受耳道清理;b. 两组均接受其他附加治疗(如全身抗生素)。 数据收集与分析:我们采用标准的Cochrane方法。我们的主要结局指标为耳漏消失或“干耳”(无论是否经耳镜证实),在1周至2周、2周至4周以及4周后进行测量;使用经过验证的工具评估与健康相关的生活质量;以及耳痛(耳内疼痛)或不适或局部刺激。次要结局指标为听力、严重并发症和耳毒性。我们使用GRADE评估每个结局指标证据的确定性。 主要结果:本次更新的综述纳入了八项新研究。总体而言,我们共识别出15项研究(2371名参与者),涉及抗生素与醋酸、醋酸铝、硼酸和聚维酮碘的七项比较。纳入的研究均未报告与健康相关的生活质量或严重并发症。1. 局部抗生素(喹诺酮类或氨基糖苷类)与局部防腐剂(醋酸) 我们纳入了七项研究(835名参与者)。与氨基糖苷类相比,醋酸在1至2周时可能会增加耳漏的消失率(低确定性证据)。与局部喹诺酮类相比,醋酸在1至2周时是否会增加耳漏的消失率非常不确定。四周后的结果仅以描述性方式呈现。与局部抗生素(氨基糖苷类和喹诺酮类)相比,醋酸是否会引起更多耳痛、不适、局部刺激或这些情况的组合非常不确定(风险比(RR)0.20,95%置信区间(CI)0.03至1.12;I² = 0%;3项研究,277名参与者;极低确定性证据)。另外两项研究(350名参与者)提供了描述性结果。描述性报告的组间听力可能几乎没有差异(喹诺酮类;低确定性证据)。关于严重并发症(氨基糖苷类)或疑似耳毒性(氨基糖苷类)的证据非常不确定(极低确定性证据)。2. 局部抗生素(喹诺酮类)与局部防腐剂(硼酸) 我们纳入了两项研究(共532名参与者)。与硼酸滴耳液相比,局部喹诺酮类在1至2周时可能会提高耳漏的消失率(RR 1.86,95% CI 1.48至2.35;1项研究,411名参与者;中等确定性证据)。这意味着在两周时,每四名接受局部抗生素(与硼酸相比)治疗的人中,会多一人耳漏消失。没有研究报告四周后耳漏的结果。与硼酸相比,喹诺酮类引起的耳痛、不适或刺激可能更少(RR 0.56,95% CI 0.32至0.98;2项研究,510名参与者;低确定性证据)。未报告疑似耳毒性和严重并发症。与局部硼酸相比,局部喹诺酮类可能会使平均听力较基线有更大改善(平均差值(MD)2.79分贝,95% CI 0.48至5.10;1项研究,390名参与者;低确定性证据),但这种差异可能没有临床意义。3. 局部抗生素(喹诺酮类)与局部防腐剂(聚维酮碘) 我们纳入了一项研究(40名参与者)。关于喹诺酮类和聚维酮碘在1至2周时耳漏消失率方面是否存在差异非常不确定(RR 1.02,95% CI 0.82至1.26;1项随机对照试验,39名参与者;极低确定性证据)。该研究定性报告两组在听力方面无差异,且无参与者出现耳毒性作用(极低确定性证据)。未报告四周后耳漏消失、耳痛、不适或刺激以及严重并发症的结果。4. 局部抗生素与局部防腐剂(醋酸铝) 我们纳入了一项研究(51名参与者;60只耳),该研究以描述性方式呈现了2至4周时耳漏消失的结果。未报告其他结果。5. 其他比较 另外三项比较评估了五项研究(966名参与者);然而,这些结果未包含在摘要中。 作者结论:与硼酸相比,局部使用抗生素(喹诺酮类)治疗CSOM在长达两周的时间内可能会提高耳漏的消失率。关于其他局部抗生素或局部防腐剂疗效的证据有限,因此我们无法得出结论。有害影响的报告也不充分。本综述的局限性包括缺乏近期数据、纳入研究质量的局限性以及关于某些人群组或干预措施的信息有限

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[1]
Chronic suppurative otitis media.

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[2]
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[6]
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Cochrane Database Syst Rev. 2021-2-9

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Aural toilet (ear cleaning) for chronic suppurative otitis media.

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