Department of Otorhinolaryngology-Head and Neck Surgery, Aarhus University Hospital, Aarhus, Denmark.
Laryngoscope. 2010 Dec;120(12):2516-20. doi: 10.1002/lary.21015.
OBJECTIVES/HYPOTHESIS: To compare the clinical failure rates among children with otorrhea through tympanostomy tubes treated with topical or systemic antibiotics versus topical saline.
Randomized, double-blind, controlled patient study.
A three-armed randomized clinical trial using topical ciprofloxacin or oral amoxicillin or topical saline. The primary outcome was treatment failure defined as presence of otorrhea in at least one ear after 7 days of treatment.
The treatment failure rates were 23% and 70% in the group treated with topical ciprofloxacin and oral amoxicillin, respectively. Treatment failures were seen in 58% of children treated with topical saline. Thus, topical ciprofloxacin significantly reduced treatment failures compared to both oral amoxicillin and topical saline. The most frequent bacteria isolated from treatment failures in general were streptococci and Moraxella catarrhalis.
The significant effect of topical ciprofloxacin is probably related to a higher local concentration of antibiotics in the middle ear rather than the result of mechanical rinsing and dissolution of the bacterial load.
目的/假设：比较鼓膜置管术治疗耳漏的儿童局部或全身使用抗生素与局部生理盐水的临床失败率。
随机、双盲、对照患者研究。
采用三臂随机临床试验，使用局部环丙沙星或口服阿莫西林或局部生理盐水。主要结局为治疗失败，定义为治疗 7 天后至少一只耳朵仍有耳漏。
局部使用环丙沙星和口服阿莫西林的治疗失败率分别为 23%和 70%。局部使用生理盐水的患儿中，有 58%治疗失败。因此，与口服阿莫西林和局部生理盐水相比，局部使用环丙沙星显著降低了治疗失败率。一般来说，治疗失败时最常分离出的细菌是链球菌和卡他莫拉菌。
局部使用环丙沙星的显著效果可能与中耳中抗生素的局部浓度较高有关，而不是机械冲洗和溶解细菌负荷的结果。
