Hu Amanda, Parnes Lorne S
Department of Otolaryngology, University of Western Ontario, London, Ontario, Canada.
Audiol Neurootol. 2009;14(6):373-82. doi: 10.1159/000241894. Epub 2009 Nov 16.
BACKGROUND/AIM: The use of intratympanic steroids (ITS) has proliferated over the past 10-15 years to include treatments for inner ear disorders, like Ménière's Disease (MD) and sudden sensorineural hearing loss (SSNHL). The aim of this study was to review the clinical trials of ITS for inner ear disorders.
PubMed and Ovid Medline databases were searched from 1966 to present for clinical trials on ITS in the treatment of MD and SSNHL. Studies were evaluated based on comparability and internal and external validity.
Thirty-eight studies were identified in total, 13 studies on MD and 25 studies on SSNHL. Most studies lacked placebo controls. Only 3 studies were double-blinded randomized prospective trials. Overall, there were heterogeneous steroid doses, treatment protocols, previous treatments, and definitions of disease and improvement.
There are no good studies on ITS that meet the criteria of comparability, internal validity, and external validity. It is difficult to compare studies due to the heterogeneous nature of the data. More rigorously designed studies are required to determine the efficacy of this treatment, the optimal steroid to use, and the best treatment regimen.
背景/目的:在过去10至15年中,鼓室内注射类固醇(ITS)的应用不断增加,涵盖了内耳疾病的治疗,如梅尼埃病(MD)和突发性感音神经性听力损失(SSNHL)。本研究的目的是回顾ITS治疗内耳疾病的临床试验。
检索了1966年至今的PubMed和Ovid Medline数据库,以查找关于ITS治疗MD和SSNHL的临床试验。根据可比性以及内部和外部有效性对研究进行评估。
共识别出38项研究,其中13项关于MD,25项关于SSNHL。大多数研究缺乏安慰剂对照。只有3项研究是双盲随机前瞻性试验。总体而言,类固醇剂量、治疗方案、既往治疗以及疾病和改善的定义存在异质性。
目前尚无符合可比性、内部有效性和外部有效性标准的关于ITS的高质量研究。由于数据的异质性,难以对各项研究进行比较。需要更严格设计的研究来确定这种治疗方法的疗效、最佳使用的类固醇以及最佳治疗方案。