AIR INFLATION EFFICACY--CORTICOSTEROID THERAPY OF OTITIS MEDIA WITH EFFUSION

充气疗效--皮质类固醇治疗渗出性中耳炎

• 批准号: 6149685
• 负责人: Cuneyt Metin Alper
• 金额: $ 23.11万
• 依托单位: CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-07-01 至 2000-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6149685
• 关键词: air treatment; atmospheric pressure; clinical research; clinical trials; combination therapy; corticosteroids; eustachian tube; exudate /transudate; hormone therapy; human subject; human therapy evaluation; magnetic resonance imaging; middle childhood (6-11); otitis media; penicillins; preschool child (1-5); relapse /recurrence; respiratory airway pressure

Otitis Media with Effusion (OME) is a common disease in the pediatric age group and remains refractory to current medical tretments. Middle ear (ME) pressure regulation is central to the maintenance of mucosal health, and dysregulation both promotes and is a consequence of OME. These considerations have generated a renewed interest in alternative non-invasive methods of maintaining stable ME pressures to prevent or treatment OME. In that regard, a variety of methods to introduce gas via the Eustachian tube, into the diseased ME has been described. However, the results of clinical studies are contradictory with reports of both no benefits of these procedures as well as high clinical cure rates for established OME. Theoretical considerations and experimental results show that the ME inflation protocols can be modified with respect to timing so as to optimize their expected physiological effect and thus their efficacy for treatment OME. However, in the absence of resolution of the underlying inflammation and/or restoration of good ME pressure regulating function, the disease is expected to recur quickly after termination of the inflation maneuvers. This is supported by the results of clinical studies that reported high recurrence rates upon discontinuing inflation. Consequently, a two-pronged intervention strategy including repeated ME air inflation to preserve ambient pressures and anti-inflammatory treatment to resolve the underlying mucosal inflammation may provide the best hope for curing persistent OME. That strategy is tested a proof-of-concept in this proposed clinical trial. Children with documented OME of at least two months duration will be randomized to receive antibiotic treatment + placebo inflation + placebo steroid (standard of care), or antibiotic + ME air inflammation + placebo steroid, or antibiotic + ME air inflation + oral corticosteroids for a one month treatment period. The cure rte for OME will be evaluated at the end of treatment and recurrence rates measured at 8 and 12 week follow-up visits. The hypotheses tested are that: 1) the two groups treated with air inflation will have comparable cure rates that are significantly greater than that of the antibiotic treatment group, and, 2) disease recurrence will be significantly greater in the group treated with inflation and placebo when compared to that treated with inflation plus corticosteroids. While primarily an evaluation of treatment efficacy for persistent OM, this study also represents a formal test of the predictive accuracy of the underlying model of disease pathogenesis.

带有积液（OME）的中耳炎是小儿年龄组的常见疾病，对当前的医疗疾病仍然难治性。中耳（ME）压力调节对于维持粘膜健康至关重要，而失调既可以促进，也是OME的结果。这些考虑因素对替代性非侵入性方法产生了新的兴趣，以维持稳定的我的压力，以预防或治疗。在这方面，已经描述了通过Eustachian Tube引入气体的各种方法，并已描述为患病的我。但是，临床研究的结果是矛盾的，有报道称这些程序没有任何好处，以及既定的OME的高临床治愈率。理论上的考虑和实验结果表明，可以在时间上修改ME通货膨胀方案，以优化其预期的生理效果，从而优化其对治疗方法的功效。但是，在没有解决潜在的炎症和/或恢复良好ME压力调节功能的情况下，预计该疾病将在通货膨胀手术终止后迅速复发。临床研究的结果支持了这一点，这些临床研究报告了停用通货膨胀后高复发率的结果。因此，一种两管齐的干预策略，包括重复我的空气通货膨胀，以保护环境压力和抗炎治疗以解决潜在的粘膜炎症，这可能为治愈持续的OME提供了最大的希望。该策略在该拟议的临床试验中测试了概念验证。具有至少两个月持续时间的OME的儿童将被随机分配以接受抗生素治疗 +安慰剂膨胀 +安慰剂类固醇（护理标准），或抗生素 + ME空气炎症 +安慰剂类固醇或抗生素 + ME空气膨胀 +口服皮质固醇一个月的治疗期。将在治疗结束时评估OME的治疗RTE，并在8和12周的随访访问中测量的复发率进行评估。所检验的假设是：1）与抗生素治疗组相比，用空气通货膨胀处理的两组将具有可比的治疗率，而在接受通货膨胀和安慰剂治疗的组中，与接受通货膨胀和皮质类固醇相比，疾病复发将明显更大。虽然主要是对持久性OM的治疗功效的评估，但本研究也代表了对疾病发病机理基础模型的预测准确性的正式检验。