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

渗出性中耳炎（OME）是儿科年龄组的常见疾病，目前的药物治疗仍然难以治愈。中耳（ME）压力调节是维持粘膜健康的核心，而失调既促进OME，也是OME的结果。这些考虑已经产生了对维持稳定ME压力以预防或治疗OME的替代非侵入性方法的新兴趣。在这方面，已经描述了通过咽鼓管将气体引入患病ME的多种方法。然而，临床研究的结果与这些手术没有益处以及已建立的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，ME充气协议可以修改相对于定时，以优化其预期的生理效果，从而其治疗OME的疗效。然而，在基础炎症未消退和/或ME压力调节功能未恢复良好的情况下，预计在充盈操作终止后疾病会迅速复发。这得到了临床研究结果的支持，这些研究报告了停止充盈后的高复发率。因此，双管齐下的干预策略，包括重复ME充气以保持环境压力和抗炎治疗以解决潜在的粘膜炎症，可能为治愈持续性OME提供最好的希望。该策略在本拟议的临床试验中进行了概念验证。记录OME至少持续两个月的儿童将随机接受抗生素治疗+安慰剂充气+安慰剂类固醇（标准治疗），或抗生素+ ME空气炎症+安慰剂类固醇，或抗生素+ ME空气充气+口服皮质类固醇，治疗期为一个月。将在治疗结束时评价OME的治愈率，并在8周和12周随访访视时测量复发率。检验的假设是：1）用空气膨胀治疗的两组将具有可比的治愈率，其显著高于抗生素治疗组，和2）与用膨胀加皮质类固醇治疗的组相比，用膨胀和安慰剂治疗的组的疾病复发将显著更高。虽然主要是评价持续性OM的治疗疗效，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.