Abelardo E, Pope L, Rajkumar K, Greenwood R, Nunez D A
Academic Department of Otolaryngology, North Bristol NHS Trust, Southmead Hospital, Bristol, BS10 5NB, UK.
Eur Arch Otorhinolaryngol. 2009 Jan;266(1):41-5. doi: 10.1007/s00405-008-0712-y. Epub 2008 Jun 17.
The objective of the study was to determine if the addition of topical antibiotic increases the efficacy of topical steroid in controlling otitis externa. A double-blind randomised controlled trial was performed from February 2003 to April 2005 in an otolaryngology emergency clinic (acute urban teaching hospital) in the United Kingdom. Patients were followed up for 2 weeks. Forty-five adults with otitis externa based on the presence of oedema, discharge or debris in the outer ear canal were recruited. The patients were randomised to one of the two treatment groups, namely using betamethasone sodium phosphate 0.1% (Vista-Methasone) or betamethasone sodium phosphate 0.1% with neomycin sulphate 0.5% (Vista-Methasone N), and were instructed to use the trial medication at three drops three times a day for 2 weeks. Subjects' visual analogue symptom scores (blockage, pain, discharge, and itching) for otitis externa pre-treatment (day 0) and post-treatment (day 15), percentage changes in visual analogue symptom scores as a result of treatment, proportion of patients whose symptom scores failed to improve or deteriorated on treatment were analysed. The two experimental arms demonstrated statistically similar presenting symptom scores at recruitment (mean symptom scores of 19.2 for betamethasone group and 28.7 for betamethasone-neomycin group). The mean symptom score change in response to treatment was 82.8 and 47.8% in the betamethasone-neomycin and betamethasone-alone groups, respectively. There was no statistically significant difference between the groups in median percentage symptom score change in response to treatment. All patients in the betamethasone-neomycin group showed symptom improvement but in the betamethasone alone group, five patients got worse (Fishers exact, P = 0.05). Topical antibiotic-steroid combination therapy is superior to steroid-alone treatment for symptomatic control of otitis externa.
本研究的目的是确定添加外用抗生素是否能提高外用类固醇治疗外耳道炎的疗效。2003年2月至2005年4月在英国一家耳鼻喉科急诊诊所（城市急性教学医院）进行了一项双盲随机对照试验。对患者进行了2周的随访。招募了45名基于外耳道存在水肿、分泌物或碎屑诊断为外耳道炎的成年人。患者被随机分为两个治疗组之一，即使用0.1%倍他米松磷酸钠（Vista-Methasone）或0.1%倍他米松磷酸钠与0.5%硫酸新霉素（Vista-Methasone N），并被指示每天滴三次，每次三滴，持续2周。分析了受试者治疗前（第0天）和治疗后（第15天）外耳道炎的视觉模拟症状评分（堵塞、疼痛、分泌物和瘙痒）、治疗后视觉模拟症状评分的百分比变化、症状评分在治疗后未改善或恶化的患者比例。两个试验组在招募时表现出统计学上相似的症状评分（倍他米松组的平均症状评分为19.2，倍他米松-新霉素组为28.7）。倍他米松-新霉素组和单用倍他米松组治疗后平均症状评分变化分别为82.8%和47.8%。两组治疗后症状评分中位数百分比变化无统计学显著差异。倍他米松-新霉素组的所有患者症状均有改善，但单用倍他米松组有5名患者病情恶化（Fisher精确检验，P = 0.05）。外用抗生素-类固醇联合治疗在外耳道炎的症状控制方面优于单用类固醇治疗。
