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

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.

许多类固醇治疗中耳积液（MEE）的研究已有报道 但是，由于样本量小或研究设计的限制，没有人 充分回答了其功效的问题，类固醇仍然存在 在推荐手术之前，对于从业者来说这是一个未经证实的选择 移除MEE。 通过精心设计的大规模试验，我们 希望澄清类固醇是否对这种常见的情况有效 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 对于治疗失败的受试者，我们也希望阐明其机制 类固醇在慢性 OME 中的作用。 该试验的目的是确定短期疗程的疗效 与阿莫西林相比，肾上腺皮质类固醇药物 单独使用阿莫西林治疗至少两种慢性 MEE 月的持续时间。 1 至 9 岁儿童，MEE 至少为 2 几个月的持续时间将被随机分配给四个治疗组之一： 1) 阿莫西林+泼尼松龙 x 14 天，然后阿莫西林再服用 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 x 14 天，然后 阿莫西林再服用 14 天，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。 全部 第 28 天访视时没有 MEE 的受试者将在第 60 天返回 气动耳镜检查和鼓室导抗测试以确定复发率。 同样，那些在第 60 天没有 MEE 的人将在第 90 天返回，而那些在第 60 天没有 MEE 的人将在第 90 天返回。 仍无积液将在第 120 天恢复。血液用于免疫球蛋白 入境时将获得同种型，并进行皮肤过敏测试 研究期间进行一次。 结果测量将是在以下时间没有积液的受试者的比例 两周和四个星期。 如果 MEE 出现复发的受试者数量 将检查第 120 天的访问。 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， 还将记录治疗组的情况。 我们估计 47 需要将受试者输入每个治疗组（总共 188 受试者）有 90% 的能力检测到绝对益处 两周内无积液的比例至少为 0.20 类固醇治疗组。