ACUTE OTITIS MEDIA--ADJUVANT THERAPY TO IMPROVE OUTCOME

急性中耳炎——改善疗效的辅助治疗

• 批准号: 6276429
• 负责人: Tasnee Chonmaitree
• 金额: $ 2.69万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6276429
• 关键词: acute disease /disorder; antihistamines; bacteria infection mechanism; chemoprevention; clinical research; clinical trial phase I; combination chemotherapy; corticosteroids; disease /disorder etiology; drug screening /evaluation; ear disorder chemotherapy; ear disorder diagnosis; exudate /transudate; human subject; human therapy evaluation; immunomodulators; infant human (0-1 year); leukotrienes; otitis media; outcomes research; relapse /recurrence; respiratory infections; tympanum

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.

尽管有有效的抗生素治疗急性 中耳炎（AOM）、治疗失败、持续性积液和 复发是常见的。 一个与不良治疗结果相关的因素 是并发病毒感染，我们已经证明这与 中耳（ME）液中炎症介质水平升高。 我们认为炎症介质，特别是组胺和 白细胞三烯，发挥重要作用，在发病机制和 从AOM中恢复，因此将测试辅助治疗是否旨在 对抗组胺作用（抗组胺剂），和/或抑制 白三烯和其他炎症物质的形成 （皮质类固醇），除了抗生素，将改善急性和长期- 通过降低初始炎症的程度来改善AOM的长期结局。 辅助药物的功效将在2个单独的， 使用随机、双盲、安慰剂的同步研究- 在四年的时间里进行控制设计。 在研究1中，将有120名患者 在AOM发作时登记。鼓室穿刺术将在 治疗5天后测量组胺和白三烯水平， 记录细菌和病毒病因。这些患者将接受随访， ME积液的持续时间。 随后将进行家访， 鼓室压测定和电话联系，直到下次急性发作，以及 然后分配到治疗组。