Thomsen Jens, Sass Kornel, Odkvist Lars, Arlinger Stig
Department of Otolaryngology/Head & Neck Surgery, Gentofte University Hospital, Hellerup, Denmark.
Otol Neurotol. 2005 Jan;26(1):68-73. doi: 10.1097/00129492-200501000-00012.
To evaluate the efficacy of a new device, the Meniett, in the treatment of Meniere's disease. The device delivers pressure pulses to the middle ear through a ventilating tube in the tympanic membrane at a frequency of 6 Hz for 0.6 second. After rising to a pressure level of 1.2 kPa, the pressure oscillates between 0.4 and 1.2 kPa. It is believed that the pressure changes are conveyed to the inner ear, inducing a transport of fluids via the pressure outlets and thus reducing the endolymphatic hydrops.
A clinical, randomized, multicenter, double-blind, placebo-controlled study. A total of 40 patients were included that had active Meniere's disease according to American Academy of Otolaryngology-Head and Neck Surgery criteria, aged between 20 and 65 years, with a history of at least eight attacks during the past year. After insertion of the ventilation tube, the patients should have had attacks of vertigo for 2 months before entering the study.
Primary study endpoints were change in frequency of vertigo, change of functionality profile, and change in patient perception of vertigo (visual analogue scale); secondary endpoints were perception of tinnitus, aural pressure, and hearing, as well as an audiologic evaluation of hearing before and after the treatment period.
The functionality level improved statistically significantly in the active group compared with the placebo group (p=0.0014), as did the visual analogue scale evaluation of vertigo (p=0.005). There was a trend toward a reduction of the frequency of vertiginous attacks that was not significant (p=0.090). With regard to the secondary endpoints, there was no statistical difference between active and placebo groups.
Local overpressure treatment is a novel treatment that is noninvasive, nondestructive, and safe. It significantly reduces vestibular symptoms in patients with Meniere's disease. The Meniett was cleared by the Food and Drug Administration in 2000.
评估一种新型设备——美尼埃特（Meniett）治疗梅尼埃病的疗效。该设备通过鼓膜上的通气管以6赫兹的频率向中耳输送压力脉冲，持续0.6秒。压力升至1.2千帕后，在0.4至1.2千帕之间振荡。据信，压力变化会传递至内耳，通过压力出口促使液体流动，从而减轻内淋巴积水。
一项临床、随机、多中心、双盲、安慰剂对照研究。根据美国耳鼻咽喉头颈外科学会标准，共纳入40例患有活动性梅尼埃病的患者，年龄在20至65岁之间，过去一年至少有8次发作史。插入通气管后，患者在进入研究前应已有2个月的眩晕发作史。
主要研究终点为眩晕频率的变化、功能状态的改变以及患者对眩晕的感知变化（视觉模拟量表）；次要终点为耳鸣、耳内压力和听力的感知，以及治疗前后的听力听力学评估。
与安慰剂组相比，治疗组的功能水平有显著统计学改善（p = 0.0014），眩晕的视觉模拟量表评估也有改善（p = 0.005）。眩晕发作频率有降低趋势，但无统计学意义（p = 0.090）。关于次要终点，治疗组与安慰剂组之间无统计学差异。
局部超压治疗是一种无创、无损且安全的新型治疗方法。它能显著减轻梅尼埃病患者的前庭症状。美尼埃特设备于2000年获得美国食品药品监督管理局批准。
