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: 2126720
• 负责人: ELLEN M MANDEL
• 金额: $ 14.55万
• 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 1999-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2126720
• 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.

类固醇治疗中耳积液的研究已有许多报道 但是，由于样本量小或研究设计的限制， 充分回答了他们的疗效问题，类固醇仍然存在， 在推荐外科手术之前， 去除污垢。 通过一个精心设计的大规模试验，我们 我希望澄清类固醇是否对这种常见的 条件 通过确定受试者的过敏和免疫状态， 通过研究存在于卵巢中的炎症介质， 治疗失败的受试者，我们也希望阐明机制， 类固醇在慢性OME中的作用。 这项试验的目的是确定短期治疗的有效性。 与阿莫西林联合使用的肾上腺皮质类固醇药物相比， 阿莫西林单独用于治疗至少两个月的慢性腹泻 个月的时间。 1至9岁的儿童，至少有两个孩子 将持续6个月的研究随机分配至4个治疗组之一： 1)阿莫西林+泼尼松龙x 14天，然后阿莫西林再持续14天， 2)阿莫西林+泼尼松龙x 14天，然后安慰剂（阿莫西林）x 14天，3）阿莫西林+安慰剂（泼尼松龙× 14天，然后 阿莫西林14天以上，或4）阿莫西林+安慰剂（用于 泼尼松龙）× 14天，然后安慰剂（阿莫西林）× 14天。 所有 在第28天访视时没有复发的受试者将在第60天返回， 充气耳镜检查和鼓室压测定以确定复发率。 同样，那些在第60天没有接种疫苗的人将在第90天恢复， 在第120天仍无渗出。 血液免疫球蛋白 将在入组时获得同种型， 在研究期间进行一次。 结局指标将是无积液的受试者比例， 两周和四周。 复发的受试者数量（如果被排除） 将检查第120天访视。 治疗的并发症和后遗症， 特别是并发传染病的数量和严重程度， 还将记录给药组的数据。 我们估计有47 受试者需要进入每个治疗组（共188例 受试者）有90%的能力检测绝对的好处， 两周时无渗出液比例至少为0.20， 类固醇治疗组。