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

中耳炎积液（OME）是一种常见的疾病，在儿童年龄组，仍然难以目前的医学治疗。中耳（ME）压力调节是维持粘膜健康的核心，而调节失调既促进了中耳压力调节，也是中耳压力调节的结果。这些考虑引起了人们对替代非侵入性方法的兴趣，以维持稳定的ME压力来预防或治疗OME。在这方面，已经描述了通过咽鼓管将气体引入病变ME的各种方法。然而，临床研究的结果与这些手术无益处以及对既定OME的高临床治愈率的报告相矛盾。理论考虑和实验结果表明，可以根据时间对ME充气方案进行修改，以优化其预期的生理效果，从而提高其治疗OME的疗效。然而，在没有解决潜在的炎症和/或恢复良好的ME压力调节功能的情况下，该疾病预计在结束充气操作后很快复发。临床研究结果证实了这一点，即停止膨胀后复发率高。因此，双管齐下的干预策略，包括反复的ME空气膨胀以保持环境压力和消炎治疗以解决潜在的粘膜炎症，可能为治疗持续性OME提供最大的希望。这一策略在这项拟议的临床试验中得到了概念验证。记录的OME持续至少两个月的儿童将随机接受抗生素治疗+安慰剂膨胀+安慰剂类固醇（标准护理），或抗生素+ ME空气炎症+安慰剂类固醇，或抗生素+ ME空气膨胀+口服皮质类固醇，为期一个月的治疗期。在治疗结束时评估OME的治愈率，并在随访8周和12周时测量复发率。经检验的假设是：1)用空气充气治疗的两组的治愈率明显高于抗生素治疗组，2)用充气和安慰剂治疗的组的疾病复发率明显高于用充气加皮质类固醇治疗的组。虽然主要是对持续性OM治疗效果的评估，但本研究也代表了对疾病发病机制基础模型预测准确性的正式测试。

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.