ACUTE OTITIS MEDIA--ADJUVANT THERAPY TO IMPROVE OUTCOME

尽管有有效的抗生素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，60名患者将被 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 在ME渗出的过程中。将对组进行比较以 细菌学和病毒学病原学，ME组胺和 白三烯水平和临床结果。研究2是一项大型临床研究 对2000名1岁以下儿童进行试验，其中有2名记录在案 以前有过OM发作，但没有表现为ME渗出。他们会被跟踪 通过家访，鼓室导纳和电话联系，直到他们的下一次 急性发作，并分成治疗组。治疗结果 将比较不同组的治疗失败率、持续时间 渗出，OM复发超过9个月。对治疗的反应也会 与OM危险因素、诊断时症状的严重程度有关，以及 呼吸道并发病毒感染的证据。 这些研究应该澄清抗组胺药的潜在益处。 和/或皮质类固醇治疗，用于治疗急性和可能的 预防婴儿复发和/或慢性OM，并阐明 辅助治疗、病毒感染、炎症之间的关系 调解人。如果这些药物被证明是有效的，它们的使用将使 对医疗保健产生重大影响。如果他们是无效的， 停止使用它们将降低成本和不便 父母。

Despite the availability for 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, 60 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. Groups will be compared for bacteriologic and virologic etiology, changes in ME histamine and leukotriene levels, and clinical outcomes. Study 2 is a large clinical trial of 2000 children, enrolled under 1 year of age with 2 documented prior episodes of OM but not present ME effusion. They will be followed by home visits with tympanometry and telephone contacts until their next acute episode, and the assigned to treatment groups. Results of treatment will be compared among groups for rate of treatment failure, duration of effusion, and recurrences of OM over 9 mo. Response to therapy will also be related to OM risk factors, severity of symptoms at diagnosis, and evidence of concurrent viral infection of the respiratory tract. These studies should clarify the potential benefits of antihistamine and/or corticosteroid therapy, both for treatment of acute and possible prevention of recurrent and/or chronic OM in infants, and shed light on associations between adjuvant treatment, viral infection, inflammatory mediators. If the drugs are proven efficacious, their use would make a significant impact on health care. If they are inefficacious, discontinuation of their use will reduce costs and inconvenience to parents.