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: 6413648
• 负责人: Tasnee Chonmaitree
• 金额: $ 27.93万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-12-01 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6413648
• 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

This study will evaluate in young children the effectiveness of new therapies for acute otitis media (AOM) which, when used in addition to standard antibiotic therapy, may help to control the actions of substances within the middle ear which appear to prolong middle ear disease. Antihistamines and corticosteriods, used separately or together in addition to antibiotic drugs, will be tested in two groups of children with acute otitis media of bacterial and/or viral origin. A group of 72 infants enrolled at the beginning of their first episode of AOM will be evaluated for organisims and substances in their middle ear fluids prior to and 5 days after drug treatment; a larger group of 200 children with histories of recurrent otitis media will be treated with the drugs and evaluated over a six month period for treatment outcome, duration of fluid in the ear, and recurrence of disease. This study should clarify the potential benefits and mechanisms of action of antihistamines and corticosteriods in the treatment of AOM, and may establish their usefulness in the prevention of recurrent or prolonged ear disease in young children. To date we have not completed enrollment of the children, therefore data have not been analyzed. Identification of improved therapies for otitis media is a very high priority because nearly all young children experience this disease, and some suffer from multiple or prolonged episodes of illness which require expensive and invasive treatment, disrupt family life, and may interfere with normal development of language and cognitive skills.

本研究将在幼儿中评估急性中耳炎（AOM）新疗法的有效性，当在标准抗生素治疗之外使用时，可能有助于控制中耳内物质的作用，这些物质似乎会延长中耳疾病。将在两组患有细菌和/或病毒源性急性中耳炎的儿童中测试抗组胺药和皮质类固醇，单独使用或与抗生素药物一起使用。 一组72名在AOM首次发作时入组的婴儿将在药物治疗前和治疗后5天评估中耳液中的有机物和物质;一组200名有复发性中耳炎病史的儿童将接受药物治疗，并在6个月内评估治疗结果、耳内液体持续时间和疾病复发。 本研究应阐明抗组胺药和皮质类固醇在治疗AOM中的潜在益处和作用机制，并可能确定其在预防幼儿耳病复发或延长中的有用性。 迄今为止，我们尚未完成儿童的入组，因此尚未分析数据。 确定中耳炎的改进疗法是一个非常高的优先级，因为几乎所有的幼儿都患有这种疾病，有些患有多次或长期发作的疾病，需要昂贵的侵入性治疗，扰乱家庭生活，并可能干扰语言和认知技能的正常发展。