ACUTE OTITIS MEDIA--ADJUVANT THERAPY TO IMPROVE OUTCOME

这项研究将评估幼儿中急性中耳炎（AOM）新疗法的有效性，当该疗法与标准抗生素疗法一起使用时，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的时间。除了抗生素药物外，还将在两组患有细菌和/或病毒性急性中耳炎的儿童中测试抗组胺药和皮质类固醇，单独或一起使用。 一组 72 名婴儿在第一次 AOM 发作开始时入组，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；更大范围的200名有复发性中耳炎病史的儿童将接受这些药物治疗，并在六个月内评估治疗结果、耳内液体持续时间和疾病复发情况。 这项研究应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耳病方面的作用。 迄今为止，我们尚未完成儿童的登记，因此尚未对数据进行分析。 确定改进的中耳炎治疗方法是当务之急，因为几乎所有幼儿都会经历这种疾病，有些儿童患有多次或长期的疾病发作，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.