Kaushik Vivek, Malik Tass, Saeed Shakeel R
Department of Otolaryngology, Head & Neck Surgery, Stockport NHS Foundation Trust, Stepping Hill Hospital, Poplar Grove, Hazel Grove, Stockport, UK, SK2 7JE.
Cochrane Database Syst Rev. 2010 Jan 20(1):CD004740. doi: 10.1002/14651858.CD004740.pub2.
Acute otitis externa is an inflammatory condition of the ear canal, with or without infection. Symptoms include ear discomfort, itchiness, discharge and impaired hearing. It is also known as 'swimmer's ear' and can usually be treated successfully with a course of ear drops.
To assess the effectiveness of interventions for acute otitis externa.
Our search for published and unpublished trials included the Cochrane Ear, Nose and Throat Disorders Group Trials Register; CENTRAL; PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; mRCT and additional sources. The date of the most recent search was 6 January 2009.
Randomised controlled trials evaluating ear cleaning, topical medication or systemic therapy in the treatment of acute otitis externa were eligible.We excluded complicated acute otitis externa; otitis externa secondary to otitis media or chronic suppurative otitis media; chronic otitis externa; fungal otitis externa (otomycosis); eczematous otitis externa; viral otitis externa and furunculosis.
Two authors assessed eligibility and quality.
Nineteen randomised controlled trials with a total of 3382 participants were included. Three meta-analyses were possible. The overall quality of studies was low.Topical antimicrobials containing steroids were significantly more effective than placebo drops: OR 11 (95% CI 2.00 to 60.57; one trial).In general, no clinically meaningful differences were noted in clinical cure rates between the various topical interventions reviewed. One notable exception involved a trial of high quality which showed that acetic acid was significantly less effective when compared with antibiotic/steroid drops in terms of cure rate at two and three weeks (OR 0.29 (95% CI 0.13 to 0.62) and OR 0.25 (95% CI 0.11 to 0.58) respectively).One trial of low quality comparing quinolone with non-quinolone antibiotics did not find any difference in clinical cure rate.No trials evaluated the effectiveness of ear cleaning.Only two trials evaluated steroid-only drops. One trial of low quality suggested no significant difference between steroid and antibiotic/steroid but did not report the magnitude or precision of the result. Another trial of moderate quality comparing an oral antihistamine with topical steroid against topical steroid alone found that cure rates in both groups were high and comparable (100% (15/15) and 94% (14/15) respectively at three weeks).
AUTHORS' CONCLUSIONS: There is a paucity of high quality trials evaluating interventions for acute otitis externa. The results of this systematic review are largely based on odds ratios calculated from single trials, most of which have very broad 95% confidence intervals because of small to modest sample sizes. The findings may not be wholly generalisable to primary care for a variety of reasons; only two of the 19 trials included in the review were conducted in a primary care population setting, and in 11 of the 19 trials ear cleaning formed part of the treatment (an intervention unlikely to be available in primary care). Despite these reservations, some meaningful conclusions can be drawn from the evidence available:Topical treatments alone, as distinct from systemic ones, are effective for uncomplicated acute otitis externa. In most cases the choice of topical intervention does not appear to influence the therapeutic outcome significantly. Any observed differences in efficacy were usually minor and not consistently present at each follow-up visit. Acetic acid was effective and comparable to antibiotic/steroid at week 1. However, when treatment needed to be extended beyond this point it was less effective. In addition, patient symptoms lasted two days longer in the acetic acid group compared to antibiotic/steroid.The evidence for steroid-only drops is very limited and as yet not robust enough to allow us to reach a conclusion or provide recommendations. Further investigation is needed.Given that most topical treatments are equally effective, it would appear that in most cases the preferred choice of topical treatment may be determined by other factors, such as risk of ototoxicity, risk of contact sensitivity, risk of developing resistance, availability, cost and dosing schedule. Factors such as speed of healing and pain relief are yet to be determined for many topical treatments and may also influence this decision.Patients prescribed antibiotic/steroid drops can expect their symptoms to last for approximately six days after treatment has begun. Although patients are usually treated with topical medication for seven to 10 days it is apparent that this will undertreat some patients and overtreat others. It may be more useful when prescribing ear drops to instruct patients to use them for at least a week. If they have symptoms beyond the first week they should continue the drops until their symptoms resolve (and possibly for a few days after), for a maximum of a further seven days. Patients with persisting symptoms beyond two weeks should be considered treatment failures and alternative management initiated.
急性外耳道炎是一种耳道炎症性疾病，可伴有或不伴有感染。症状包括耳部不适、瘙痒、分泌物增多及听力受损。它也被称为“游泳者耳炎”，通常使用一个疗程的滴耳液即可成功治愈。
评估急性外耳道炎干预措施的有效性。
我们检索了已发表和未发表的试验，包括Cochrane耳鼻喉疾病组试验注册库、CENTRAL、PubMed、EMBASE、CINAHL、科学引文索引、BIOSIS预评文摘、剑桥科学文摘、mRCT及其他来源。最近一次检索日期为2009年1月6日。
评估耳部清洁、局部用药或全身治疗急性外耳道炎的随机对照试验符合要求。我们排除了复杂性急性外耳道炎；继发于中耳炎或慢性化脓性中耳炎的外耳道炎；慢性外耳道炎；真菌性外耳道炎（耳霉菌病）；湿疹性外耳道炎；病毒性外耳道炎及外耳道疖肿。
两位作者评估了入选资格和质量。
纳入了19项随机对照试验，共3382名参与者。可进行三项荟萃分析。研究的总体质量较低。含类固醇的局部抗菌药物比安慰剂滴耳液显著更有效：比值比11（95%可信区间2.00至60.57；一项试验）。总体而言，在所审查的各种局部干预措施之间，临床治愈率未发现有临床意义的差异。一个显著的例外是一项高质量试验，该试验表明，在两周和三周时，与抗生素/类固醇滴耳液相比，醋酸在治愈率方面显著较低（分别为比值比0.29（95%可信区间0.13至0.62）和比值比0.25（95%可信区间0.11至0.58））。一项低质量试验比较了喹诺酮类与非喹诺酮类抗生素，未发现临床治愈率有差异。没有试验评估耳部清洁的有效性。只有两项试验评估了仅含类固醇的滴耳液。一项低质量试验表明类固醇与抗生素/类固醇之间无显著差异，但未报告结果的大小或精确度。另一项中等质量试验比较了口服抗组胺药与局部类固醇联合使用与单独使用局部类固醇，发现两组的治愈率都很高且相当（三周时分别为100%（15/15）和94%（14/15））。
评估急性外耳道炎干预措施的高质量试验较少。本系统评价的结果主要基于单个试验计算的比值比，由于样本量小至中等，其中大多数试验的95%可信区间非常宽。由于多种原因，这些结果可能无法完全推广到初级保健；纳入评价的19项试验中只有两项是在初级保健人群中进行的，并且在19项试验中的11项中，耳部清洁是治疗的一部分（这是初级保健中不太可能有的干预措施）。尽管有这些保留意见，但从现有证据中仍可得出一些有意义的结论：与全身治疗不同，单独的局部治疗对非复杂性急性外耳道炎有效。在大多数情况下，局部干预措施的选择似乎对治疗结果没有显著影响。观察到的任何疗效差异通常较小，且在每次随访时并不一致出现。醋酸在第1周时有效且与抗生素/类固醇相当。然而，当治疗需要延长超过此时，其效果较差。此外，与抗生素/类固醇组相比，醋酸组患者症状持续时间长两天。仅含类固醇滴耳液的证据非常有限，目前还不够有力，无法让我们得出结论或提供建议。需要进一步研究。鉴于大多数局部治疗同样有效，在大多数情况下，局部治疗的首选可能由其他因素决定，如耳毒性风险、接触敏感性风险、产生耐药性的风险、可获得性、成本和给药方案。许多局部治疗的愈合速度和疼痛缓解等因素尚未确定，也可能影响这一决定。开了抗生素/类固醇滴耳液的患者预计治疗开始后症状将持续约六天。尽管患者通常接受局部用药治疗7至10天，但显然这会对一些患者治疗不足，而对另一些患者治疗过度。开滴耳液时，指导患者至少使用一周可能更有用。如果他们在第一周后仍有症状，应继续使用滴耳液，直到症状缓解（可能在症状缓解后再使用几天），最长再使用七天。症状持续超过两周的患者应被视为治疗失败，并开始采取替代治疗措施。
