SYSTEMIC STEROID FOR CHRONIC OTITIS MEDIA WITH EFFUSION

全身类固醇治疗慢性渗出性中耳炎

• 批准号: 2126719
• 负责人: ELLEN M MANDEL
• 金额: $ 17.94万
• 依托单位: CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-04-01 至 1997-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2126719
• 关键词: audiometry; auditory reflex; child (0-11); chronic disease /disorder; clinical chemistry; clinical trials; combination chemotherapy; ear disorder chemotherapy; exo alpha sialidase; free fatty acids; human subject; human therapy evaluation; leukotrienes; otitis media; penicillins; prednisolone; prostaglandin E

Many studies of steroids for middle ear effusion (MEE) have been reported but, due to small sample size or limitations in study design, none have adequately answered the question of their efficacy, and steroids remain an unproven option for practitioners prior to recommending surgical removal of the MEE. By means of a well designed large-scale trial, we hope to clarify whether steroids are efficacious for this common condition. By determining the subjects' allergy and immune status and by studying the inflammatory mediators present in the MEE of unsuccessfully treated subjects, we also hope to clarify the mechanisms of action of steroids in chronic OME. The aim of this trial is to determine the efficacy of a short course of an adrenocorticosteroid agent given with amoxicillin as compared to that of amoxicillin alone for the treatment of chronic MEE of at least two months' duration. Children 1 to 9 years of age with MEE of at least two months' duration will be randomly assigned to one of four treatment arms: 1) amoxicillin+prednisolone x 14 days, then amoxicillin for 14 more days, 2) amoxicillin+prednisolone x 14 days, then placebo (for amoxicillin) x 14 days, 3) amoxicillin+placebo (for prednisolone x 14 days, then amoxicillin for 14 more days, or 4) amoxicillin+placebo (for prednisolone) x 14 days, then placebo (for amoxicillin) x 14 days. All subjects with no MEE at the Day 28 visit will return at Day 60 for pneumatic otoscopy and tympanometry to ascertain recurrence rates. Likewise, those with no MEE at Day 60 will return at Day 90, and those still effusion-free will return at Day 120. Blood for immunoglobulin isotypes will be obtained at entry and allergy skin testing will be performed once during the study. Outcome measures will be the proportion of subjects without effusion at two and four weeks. The number of subjects with recurrence if MEE by the Day 120 visit will be examined. Complications and sequelae of treatment, especially the number and severity of intercurrent infectious diseases, will also be recorded for the treatment groups. We estimate that 47 subjects need to be entered in each treatment arm (a total of 188 subjects) to have 90 percent power of detecting an absolute benefit of at least 0.20 in the proportion effusion-free at two weeks for the steroid-treated groups.

已有许多关于类固醇治疗中耳积液(MEE)的研究报道 但是，由于样本量小或研究设计的限制，没有一个人 充分回答了它们的有效性问题，类固醇仍然存在 对于医生来说，在推荐手术之前，这是一个未经证实的选择 移走Mee。通过精心设计的大规模试验，我们 希望澄清类固醇对这种常见疾病是否有效 条件。通过确定受试者的过敏和免疫状态以及 通过研究大脑皮层中存在的炎症介质 未成功治疗的受试者，我们也希望阐明其机制 类固醇在慢性OME中的作用。 这项试验的目的是确定一个短疗程的疗效 阿莫西林与阿莫西林治疗肾上腺皮质类固醇药物的比较 阿莫西林单独治疗至少2例慢性梅毒 数月的持续时间。1至9岁，最低生活质量指数至少为2岁的儿童 几个月的持续时间将随机分配给四个治疗臂中的一个： 1)阿莫西林+强的松龙x14天，然后阿莫西林再14天， 2)阿莫西林+强的松龙x 14天，然后安慰剂(阿莫西林)x 14天，3)阿莫西林+安慰剂(强的松龙×14天，然后 阿莫西林再服用14天，或4)阿莫西林+安慰剂(用于 强的松龙)×14天，然后安慰剂(阿莫西林)×14天。全 在第28天的访问中没有MEE的受试者将在第60天返回 充气耳镜和鼓室导纳以确定复发率。 同样，那些在第60天没有MEE的人将在第90天返回，而那些 仍无积液将在第120天恢复。血液换免疫球蛋白 在入境时将获得同种异型，过敏皮肤测试将 在研究期间进行了一次。 结果衡量标准将是受试者中没有渗出的比例 两周和四周。MEE的复发受试者的数量 第120天的访问将被审查。治疗的并发症和后遗症， 尤其是并发传染病的数量和严重程度， 治疗组也将被记录下来。我们估计有47 受试者需要进入每个治疗臂(总共188个 受试者)拥有90%的检测绝对收益的能力 至少0.20的比例-两周内无积液 类固醇治疗组。