Chong Lee Yee, Head Karen, Webster Katie E, Daw Jessica, Strobel Natalie A, Richmond Peter C, Snelling Tom, Bhutta Mahmood F, Schilder Anne Gm, Brennan-Jones Christopher G
Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Population Health Sciences, University of Bristol, Bristol, UK.
Cochrane Database Syst Rev. 2025 Jun 9;6(6):CD013053. doi: 10.1002/14651858.CD013053.pub3.
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, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Antibiotics are the most common treatment for CSOM, and aim to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be administered both topically and systemically, and can be used alone or in addition to other treatments for CSOM, such as ear cleaning (aural toileting). This is the first update of a review published in 2021. The update found no new studies. It is one of a suite of seven Cochrane reviews evaluating the effects of non-surgical interventions for CSOM. OBJECTIVES: To assess the benefits and harms of topical versus systemic antibiotics for people with 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 the ear discharge had continued for more than two weeks. The studies compared topical antibiotics versus systemic (oral, injection) antibiotics. The two main comparisons were the same type of antibiotic in both treatment groups and different types of antibiotics in each group. Within each comparison, we separated studies into 1. those in which both groups of participants had received aural toileting in addition to the antibiotics, and those where neither group had received aural toileting, and 2. those in which both groups received some other concomitant treatment (such as topical antiseptics) and those with no such concomitant treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. 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 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 update did not find any new studies. We included six studies (445 participants), all with high risk of bias. Three studies included participants with confirmed CSOM, where perforation of the ear drum was clearly documented. None of the studies reported results for resolution of ear discharge after four weeks or health-related quality of life. 1. Topical quinolone versus systemic quinolone Four studies (325 participants) compared topical versus systemic (oral) administration of ciprofloxacin. Topical administration may slightly increase resolution of ear discharge at one to less than two weeks (risk ratio (RR) 1.50, 95% confidence interval (CI) 1.22 to 1.84; 2 studies, 210 participants; low-certainty evidence). These studies either did not mention aural toileting or limited it to the first visit. Three studies (265 participants) reported that they did not suspect ototoxicity in any participants, but it is unclear how this was measured (very low-certainty evidence). No studies reported the outcomes of resolution after four weeks, health-related quality of life, ear pain, or serious complications. No studies reported results for hearing, despite it being measured in three studies. 2. Topical quinolone versus systemic aminoglycosides One study (60 participants) compared topical ciprofloxacin versus gentamicin injected intramuscularly. No aural toileting was reported. Resolution of ear discharge was not measured at one to two weeks. The study did not report any "side effects" from which we assumed that no ear pain, suspected ototoxicity, or serious complications occurred (very low-certainty evidence). The study stated that "no worsening of the audiometric function related to local or parenteral therapy was observed." 3. Topical quinolone versus systemic penicillin plus beta-lactamase inhibitor One study (60 participants) compared topical ofloxacin versus oral amoxicillin-clavulanic acid with all participants receiving suction ear cleaning at the first visit. Oral amoxicillin-clavulanic acid may increase the resolution of ear discharge at one to less than two weeks compared to topical ofloxacin, but the evidence is very uncertain. The evidence is also very uncertain about the effects of topical ofloxacin compared with oral amoxicillin-clavulanic acid on ear pain, hearing, or suspected ototoxicity (all very low-certainty evidence). No studies reported the outcomes of resolution after four weeks, health-related quality of life, and serious complications. AUTHORS' CONCLUSIONS: There was a limited amount of low- or very low-quality evidence available, from studies completed over 15 years ago, to determine whether topical or systemic antibiotics are more effective in achieving resolution of ear discharge for people with CSOM. This was mostly due to high risk of bias in the studies and imprecision. However, amongst this uncertainty, there is some evidence to suggest that the topical administration of quinolone antibiotics may be slightly more effective than systemic administration of antibiotics in achieving resolution of ear discharge (dry ear). There is limited evidence available regarding different types of topical antibiotics. It is not possible to determine with any certainty whether topical quinolones are better or worse than systemic aminoglycosides. These two groups of compounds have different adverse effect profiles, but there is insufficient evidence from the included studies to make any comment about these. In general, harmful effects were poorly reported. Limitations of the review include lack of recency in data, and limited information on certain population groups or interventions.
背景:慢性化脓性中耳炎(CSOM),有时也被称为慢性中耳炎,是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。抗生素是CSOM最常见的治疗方法,旨在杀死或抑制可能导致感染的微生物生长。抗生素可局部和全身给药,可单独使用或作为CSOM其他治疗方法(如耳部清洁(耳道冲洗))的辅助用药。这是2021年发表的一篇综述的首次更新。此次更新未发现新的研究。这是评估CSOM非手术干预效果的七篇Cochrane综述之一。 目的:评估局部使用抗生素与全身使用抗生素对CSOM患者的益处和危害。 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。 入选标准:我们纳入了至少为期一周随访的随机对照试验(RCT),试验对象为患有原因不明的慢性耳漏或CSOM的成人和儿童,耳漏持续时间超过两周。研究比较了局部使用抗生素与全身(口服、注射)使用抗生素。两个主要比较为:两个治疗组使用相同类型抗生素,以及每组使用不同类型抗生素。在每个比较中,我们将研究分为:1. 两组参与者除抗生素外均接受了耳道冲洗的研究,以及两组均未接受耳道冲洗的研究;2. 两组均接受了其他伴随治疗(如局部防腐剂)的研究,以及未接受此类伴随治疗的研究。 数据收集与分析:我们采用标准的Cochrane方法学程序。我们的主要结局为:耳漏消失或“干耳”(无论耳镜检查是否确认,在1周至不到2周、2周至4周以及4周后测量)、使用经过验证的工具评估的健康相关生活质量,以及耳痛(耳胀痛)或不适或局部刺激。次要结局为听力、严重并发症和耳毒性。我们使用GRADE评估每个结局证据的确定性。 主要结果:此次更新未发现任何新的研究。我们纳入了六项研究(445名参与者),所有研究的偏倚风险均较高。三项研究纳入了确诊为CSOM的参与者,其中鼓膜穿孔有明确记录。没有研究报告四周后耳漏消失或健康相关生活质量的结果。1. 局部使用喹诺酮类药物与全身使用喹诺酮类药物 四项研究(325名参与者)比较了环丙沙星的局部给药与全身(口服)给药。局部给药可能会在1周至不到2周时略微提高耳漏消失率(风险比(RR)1.50,95%置信区间(CI)1.22至1.84;2项研究,210名参与者;低确定性证据)。这些研究要么未提及耳道冲洗,要么将其限制在首次就诊时。三项研究(265名参与者)报告称,他们未怀疑任何参与者出现耳毒性,但不清楚这是如何测量的(极低确定性证据)。没有研究报告四周后的结局、健康相关生活质量、耳痛或严重并发症。尽管三项研究测量了听力,但没有研究报告听力结果。2. 局部使用喹诺酮类药物与全身使用氨基糖苷类药物 一项研究(60名参与者)比较了局部使用环丙沙星与肌肉注射庆大霉素。未报告耳道冲洗情况。未测量1至2周时耳漏的消失情况。该研究未报告任何“副作用”,由此我们假设未发生耳痛、疑似耳毒性或严重并发症(极低确定性证据)。该研究称“未观察到与局部或胃肠外治疗相关的听力功能恶化”。3. 局部使用喹诺酮类药物与全身使用青霉素加β-内酰胺酶抑制剂 一项研究(60名参与者)比较了局部使用氧氟沙星与口服阿莫西林-克拉维酸,所有参与者在首次就诊时均接受了耳部吸引清洁。与局部使用氧氟沙星相比,口服阿莫西林-克拉维酸可能会在1周至不到2周时提高耳漏消失率,但证据非常不确定。关于局部使用氧氟沙星与口服阿莫西林-克拉维酸对耳痛、听力或疑似耳毒性的影响,证据也非常不确定(均为极低确定性证据)。没有研究报告四周后的结局、健康相关生活质量和严重并发症。 作者结论:现有证据有限且质量低或极低,这些证据来自15年前完成的研究,难以确定局部使用抗生素还是全身使用抗生素对CSOM患者耳漏消失更有效。这主要是由于研究中的偏倚风险高且结果不精确。然而,在这种不确定性中,有一些证据表明,局部使用喹诺酮类抗生素在实现耳漏消失(干耳)方面可能比全身使用抗生素略有效。关于不同类型局部抗生素的证据有限。无法确定局部喹诺酮类药物比全身使用氨基糖苷类药物更好还是更差。这两类化合物有不同的不良反应,但纳入研究中的证据不足,无法对此发表任何评论。总体而言,有害影响的报告较少。该综述的局限性包括数据缺乏时效性,以及关于某些人群组或干预措施的信息有限。
Cochrane Database Syst Rev. 2025-6-9
Cochrane Database Syst Rev. 2025-6-9
Cochrane Database Syst Rev. 2025-6-9
Cochrane Database Syst Rev. 2025-6-9
Cochrane Database Syst Rev. 2025-6-9
Cochrane Database Syst Rev. 2025-6-9
Cochrane Database Syst Rev. 2021-2-4
Cochrane Database Syst Rev. 2025-6-9
Cochrane Database Syst Rev. 2021-2-9
Cochrane Database Syst Rev. 2020-1-2
Lancet. 2024-5-25
Int J Pediatr Otorhinolaryngol. 2023-11
Cochrane Database Syst Rev. 2023-2-27
Cochrane Database Syst Rev. 2021-2-4
Cochrane Database Syst Rev. 2020-8-27
Glob Public Health. 2022-12
Cochrane Database Syst Rev. 2021-2-9
Can Fam Physician. 2020-9