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

渗出性中耳炎(OME)是儿科年龄段的常见病，对目前的内科治疗仍难治。中耳(ME)压力调节是维持粘膜健康的核心，而调节失调既促进中耳健康又是中耳健康的后果。这些考虑重新引起了人们对替代的非侵入性方法的兴趣，这些方法可以保持稳定的ME压力，以预防或治疗OME。在这方面，已经描述了通过咽鼓管将气体引入患病的ME的各种方法。然而，临床研究的结果与关于这些程序没有好处以及已建立的OME的高临床治愈率的报道相矛盾。理论考虑和实验结果表明，ME充气方案可以在时机上进行修改，以优化其预期的生理效果，从而优化其治疗OME的效果。然而，在潜在的炎症没有消退和/或没有恢复良好的ME压力调节功能的情况下，预计在结束充气操作后，疾病将迅速复发。这一点得到了临床研究结果的支持，这些研究报告了在停止通货膨胀后的高复发率。因此，双管齐下的干预策略，包括重复ME充气以维持环境压力和抗炎治疗以消除潜在的粘膜炎症，可能为治愈持续性OME提供最好的希望。这一策略在这项拟议的临床试验中得到了概念验证。记录在案的OME持续时间至少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(标准护理)，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，为期一个月。将在治疗结束时评估OME的治愈RTE，并在8周和12周的随访中测量复发率。测试的假设是：1)空气充气治疗的两组患者具有类似的治愈率，显著高于抗生素治疗组；2)与充气加皮质类固醇治疗组相比，充气和安慰剂治疗组的疾病复发率明显更高。虽然这项研究主要是对持续性OM的治疗效果的评估，但也代表了对疾病发病机制潜在模型的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.