ACUTE OTITIS MEDIA--ADJUVANT THERAPY TO IMPROVE OUTCOME

尽管有有效的抗生素可用于治疗急性胰腺炎 中耳炎(AOM)、治疗失败、持续渗出和 反复发作是很常见的。一个与治疗结果不佳有关的因素 是并发病毒感染，我们已经证明这与 中耳(ME)液中炎性介质水平升高。 我们认为炎症介质，特别是组胺和 白三烯在糖尿病的发病机制中起重要作用。 从AOM中恢复，因此将测试辅助治疗是否针对 抗组胺作用(抗组胺)，和/或抑制 白三烯和其他炎性物质的形成 (皮质类固醇)，除抗生素外，还将改善急性和长期- 通过减轻最初炎症的程度来治疗AOM的远期结局。 这些辅助药物的疗效将在两个不同的地方进行测试， 使用随机、双盲、安慰剂的同步研究- 为期4年的受控设计。在研究1中，120名患者将 在AOM开始时注册。鼓室穿刺术将在 并在治疗后5天检测组胺和白三烯水平 记录细菌和病毒病原学。将对这些患者进行跟踪治疗 ME渗出的持续时间。他们之后将进行家访， 鼓室测试和电话联系，直到他们的下一次急性发作，以及 然后分配到治疗组。

Despite the availability of effective antibiotics for treatment of acute otitis media (AOM), treatment failures, persistent effusions and recurrences are common. One factor associated with poor treatment outcome is concurrent viral infection, which we have shown to be associated with increased levels of inflammatory mediators in the middle ear (ME) fluids. We propose that inflammatory mediators, particularly histamine and leukotrienes, play a significant role in both the pathogenesis of and recovery from AOM, and therefore will test whether adjuvant therapy aimed at counteracting histamine actions (antihistamine), and/or inhibiting formation of leukotrienes and other inflammatory substances (corticosteroid), in addition to antibiotic, will improve acute and long- term outcome of AOM by reducing the degree of the initial inflammation. The efficacy of the adjuvant drugs will be tested in 2 separate, simultaneous studies which use a randomized, double-blind, placebo- controlled design over a 4-year period. In Study 1, 120 patients will be enrolled at the onset of AOM. Tympanocentesis will be performed prior to and 5 days into therapy to measure histamine and leukotriene levels and document bacterial and viral etiology. These patients will be followed for the duration of ME effusion. They will be followed by home visits with tympanometry and telephone contacts until their next acute episode, and then assigned to treatment groups.