ACUTE OTITIS MEDIA--ADJUVANT THERAPY TO IMPROVE OUTCOME

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，这些物质似乎延长了中耳疾病。将在两组细菌性和/或病毒性急性中耳炎患儿中试验抗组胺药和皮质类固醇，除抗生素药物外，可单独或联合使用。在首次急性中耳炎发作开始时招募的72名婴儿将在药物治疗前和药物治疗后5天对其中耳液中的微生物和物质进行评估；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、耳内积液持续时间和疾病复发情况。本研究旨在阐明抗组胺药和皮质类固醇治疗AOM的潜在益处和作用机制，并可能确定它们在预防幼儿复发性或长期性耳部疾病方面的有效性。到目前为止，我们还没有完成儿童的入组，因此没有对数据进行分析。确定中耳炎的改进疗法是一项非常重要的优先事项，因为几乎所有幼儿都患有这种疾病，有些儿童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。

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.