Division of Otorhinolaryngology, Faculty of Health Sciences, University of Stellenbosch/Tygerberg Hospital, Cape Town, South Africa.
Clin Otolaryngol. 2012 Aug;37(4):261-70. doi: 10.1111/j.1749-4486.2012.02532.x.
Primary: to compare one-off administration of boric acid powder with courses of 1% acetic acid and ciprofloxacin eardrops in treating active chronic otitis media. Secondary: to evaluate the effectiveness of Quadriderm® cream in resistant active chronic otitis media; and to document side effects of these treatments, especially hearing loss.
Randomised controlled trial.
Outpatient department of a tertiary ENT unit.
Hundred and fifty-nine patients over 6 years old with active chronic mucosal (without cholesteatoma) otitis media randomised to receive one of the three primary agents.
All techniques employed were suitable for primary healthcare givers as well as specialists. After confirming eligibility, patients were randomly allocated to treatment. All ears underwent toilet with irrigation using clean water, a syringe and ambient light, with or without dry mopping, until the perforation was visible. The randomised solution was flushed through the middle ear and eustachian tube using a 'tragal pump' technique: saline was used as the solution for flushing in the boric acid powder arm. Patients allocated topical ear medication were given a bottle of eardrops to administer (six drops twice daily, 'pumped in') until finished. Those allocated boric acid powder had the external ear canals filled as a one-off treatment. Patients were followed up monthly thereafter.
Primary: Dry (inactive) middle ears as assessed by the doctor. Secondary: Patient assessment of success; microbiologic culture and sensitivity; audiologic changes because of treatment; complications of treatment; costs of therapies.
Ciprofloxacin eardrops and boric acid powder were statistically superior to 1% acetic acid eardrops in rendering active chronic otitis media inactive (73% dry ears for ciprofloxacin; 67% for boric acid powder; and 24% for acetic acid). There was no difference between the success rates of ciprofloxacin eardrops and boric acid powder. Quadriderm cream was effective in 85% of patients failing first-line therapy. No agent caused significant complications and specifically no hearing loss.
This study showed a single application of boric acid powder following external auditory canal irrigation until the perforation was visible to be as effective as the current best practice of topical quinolone eardrops in active chronic otitis media. Boric acid powder is inexpensive and does not require patient compliance. Boric acid powder is a viable, less costly alternative to topical antibiotic/steroid ear drops in the developing world for active chronic otitis media. Acetic acid eardrops 1% are ineffective. Quadriderm cream, given as a one-off therapy, also appears to be effective.
主要目的：比较硼酸粉单次给药与 1%醋酸和环丙沙星滴耳液治疗活动性慢性中耳炎的疗效。次要目的：评估 Quadriderm®乳膏在难治性活动性慢性中耳炎中的疗效；记录这些治疗方法的副作用，特别是听力损失。
随机对照试验。
三级耳鼻喉科门诊。
159 名 6 岁以上患有活动性慢性黏膜（无胆脂瘤）中耳炎的患者，随机接受三种主要药物之一的治疗。
所有采用的技术均适合初级保健提供者和专家。在确认合格后，患者被随机分配到治疗组。所有耳朵均采用清水、注射器和自然光进行冲洗，辅以或不辅以干法清洁，直至穿孔可见。将随机溶液通过“耳屏泵”技术冲洗中耳和咽鼓管：硼酸粉组使用生理盐水冲洗。局部耳部用药组患者给予一瓶滴耳液，每天滴耳 6 次（“泵入”），直至用完。接受硼酸粉治疗的患者一次性将外耳道填满。此后，患者每月随访一次。
主要结果：医生评估的干性（非活动性）中耳。次要结果：患者对治疗效果的评估；微生物培养和药敏；治疗引起的听力变化；治疗并发症；治疗费用。
环丙沙星滴耳液和硼酸粉在治疗活动性慢性中耳炎方面均优于 1%醋酸滴耳液，使中耳炎转为非活动性（环丙沙星组 73%的耳朵干燥；硼酸粉组 67%；醋酸组 24%）。环丙沙星滴耳液和硼酸粉的成功率无差异。一线治疗失败的 85%患者使用 Quadriderm 乳膏有效。没有一种药物引起明显的并发症，特别是没有听力损失。
本研究表明，在冲洗外耳道直至穿孔可见后，单次应用硼酸粉与目前治疗活动性慢性中耳炎的最佳局部喹诺酮滴耳液疗效相同。硼酸粉价格低廉，不需要患者依从性。硼酸粉是发展中国家治疗活动性慢性中耳炎的一种可行的、成本较低的替代局部抗生素/类固醇滴耳液。1%醋酸滴耳液无效。一次性使用 Quadriderm 乳膏也似乎有效。
