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: 2126718
• 负责人: ELLEN M MANDEL
• 金额: $ 17.24万
• 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/2126718
• 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; 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.

已经报道了许多用于中耳积液（MEE）类固醇的研究 但是，由于样本量较小或研究设计的局限性，没有一个 充分回答了其功效的问题，类固醇仍然存在 在建议外科手术之前，从业者未经证实的选择 删除mee。 通过精心设计的大规模试验，我们 希望澄清类固醇是否有效 健康）状况。 通过确定受试者的过敏和免疫状态以及 通过研究MEE中存在的炎症介质 未成功治疗的主题，我们也希望澄清机制 类固醇在慢性OME中的作用。 该试验的目的是确定短期课程的功效 与此相比 仅阿莫西林的慢性MEE至少两种 持续时间。 1至9岁的儿童至少有两个 持续时间将随机分配到四个治疗臂之一： 1）阿莫西林+泼尼松龙X 14天，然后再添加14天， 2）阿莫西林+泼尼松龙X 14天，然后安慰剂（用于阿莫西林）x 14天，3）阿莫西林+安慰剂（用于泼尼松龙X 14天，然后 阿莫西林再14天，或4）阿莫西林+安慰剂（用于 泼尼松龙）x 14天，然后安慰剂（用于阿莫西林）x 14天。 全部 当天没有MEE的受试者28访问将在第60天返回 气动耳镜和鼓膜测定法，以确定复发率。 同样，第60天没有MEE的人也会在第90天返回 仍然无积液在第120天返回。免疫球蛋白的血液 进入时将获得同型，并且过敏皮肤测试将是 在研究期间进行一次。 结果指标将是受试者而没有积液的比例 两个星期和四个星期。 如果由 第120天访问将进行检查。 并发症和后遗症， 尤其是间流传染病的数量和严重程度， 还将记录治疗组的记录。 我们估计47 需要在每个治疗组中输入受试者（总计188 受试者）具有90％的能力来检测绝对好处 至少在两周内无积液比例的0.20 类固醇处理的组。