Liebau Arne, Pogorzelski Olivia, Salt Alec N, Plontke Stefan K
*Department of Otorhinolaryngology, Head and Neck Surgery, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany †Department of Otolaryngology, Washington University School of Medicine, St. Louis, Missouri, U.S.A.
Otol Neurotol. 2017 Jan;38(1):19-30. doi: 10.1097/MAO.0000000000001254.
Controlled and uncontrolled studies with primary intratympanic or combined intratympanic and systemic application of glucocorticosteroids for idiopathic sudden hearing loss were analyzed by means of a meta-analysis in an attempt to establish optimal local drug delivery protocols.
A total of 25 studies with 28 treatment groups between January 2000 and June 2014 were selected that adequately described drug delivery protocols. Cochlear drug levels were calculated by a validated computer model of drug dispersion in the inner ear fluids based on the concentration and volume of glucocorticoids applied, the time the drug remained in the middle ear, and the specific timing of injections. Various factors were compared with hearing outcome, including baseline data, individual parameters of the application protocols, calculated peak concentration (Cmax), and total dose (area under the curve).
There was no dependence of hearing outcome on individual parameters of the application protocol, Cmax, or area under the curve. Final hearing threshold was notably independent of delay of treatment.
During primary intratympanic or combined steroid therapy of idiopathic sudden hearing loss, the tendency toward early treatment having a positive effect on hearing improvement is thought to be a "sham effect," likely related to spontaneous recovery. Change in pure-tone average may not be an adequate outcome parameter to assess effectiveness of the intervention, as it depends on the degree of initial hearing loss. Final pure-tone average provides a better alternative.
通过荟萃分析对原发性鼓室内或联合鼓室内及全身应用糖皮质激素治疗特发性突聋的对照研究和非对照研究进行分析，以建立最佳的局部给药方案。
选取2000年1月至2014年6月期间共25项研究中的28个治疗组，这些研究充分描述了给药方案。基于所应用糖皮质激素的浓度和体积、药物在中耳内停留的时间以及注射的具体时间，通过经过验证的内耳液中药物扩散计算机模型计算耳蜗内药物水平。将各种因素与听力结果进行比较，包括基线数据、应用方案的个体参数、计算得出的峰浓度（Cmax）和总剂量（曲线下面积）。
听力结果与应用方案的个体参数、Cmax或曲线下面积无关。最终听力阈值明显与治疗延迟无关。
在原发性鼓室内或联合类固醇治疗特发性突聋期间，早期治疗对听力改善有积极作用的趋势被认为是一种“假效应”，可能与自发恢复有关。纯音平均听阈变化可能不是评估干预效果的合适结局参数，因为它取决于初始听力损失的程度。最终纯音平均听阈提供了更好的选择。
