Department of Otolaryngology, Guglielmo da Saliceto Hospital, Piacenza, Italy.
Otol Neurotol. 2009 Dec;30(8):1111-5. doi: 10.1097/MAO.0b013e3181b76b08.
To compare 3 different devices used to perforate the stapes footplate in otosclerotic patients.
The study design was a prospective unblinded study. It was conducted at the ENT Department of a general hospital.
Ninety subjects undergoing primary stapedotomy for otosclerosis by a senior surgeon participated. A stapedotomy operation was performed under local anesthesia with reversed sequence of surgical steps. Three different devices were used to perforate the posterior half of the footplate: a microdrill (MD), a CO2 laser (CO2), and a Piezosurgery bone device (PZS). The hole diameter was 0.7 mm. Three consecutive samples of unselected patients were recruited. All patients of each sample were operated with the same device. Main outcome measures were preoperative and postoperative air- (AC) and bone-conduction (BC) audiometry, intraoperative findings, and postoperative complications. Postoperative pure-tone audiometry was done 1 month after surgery.
The CO2 laser was used in 30 stapedotomies, the PZS in 30, and the MD was used in 30. Bone-conduction pure-tone averages did not worsen in the MD and CO2 groups. CO2 laser shows a trend toward less residual air-bone gap and more functional gain at low frequencies. Piezosurgery bone device patients lost approximately 10 dB in BC at 4,000 Hz. Significant differences in AC thresholds gain and in the residual air-bone gap were found between groups. Piezosurgery bone device patients had less gain and more residual gap at high frequencies as a result of a slight deterioration of BC threshold. A higher rate of postoperative vertigo was also found in PZS patients.
The use of the CO2 laser seems associated with the best functional results, although on a statistical basis, they do not differ significantly from that obtained with the standard MD platinotomy. The PZS stapedotomy is effective from a surgical point of view for most patients. However, it is associated with a slight but significant deterioration of BC at high frequency and at higher vertigo rate. More basic validation of the stimulation parameters is necessary for safe use of this new technology.
比较三种不同设备在耳硬化症患者中行镫骨底板打孔的效果。
前瞻性、非盲法研究。在一家综合医院的耳鼻喉科进行。
90 名接受初级镫骨切开术治疗耳硬化症的患者参与了研究。手术在局部麻醉下进行，手术步骤逆行。使用三种不同的设备来穿透底板的后半部分：微型钻头（MD）、二氧化碳激光（CO2）和 Piezosurgery 骨设备（PZS）。孔径为 0.7 毫米。连续招募了三组未选择的患者。每组患者均使用同一种设备进行手术。主要的观察指标包括术前和术后的气导（AC）和骨导（BC）听力测试、术中发现和术后并发症。术后 1 个月进行纯音听力测试。
30 例手术采用 CO2 激光，30 例采用 PZS，30 例采用 MD。MD 和 CO2 组的骨导纯音平均值没有恶化。CO2 激光显示出在低频时更小的残余气骨间隙和更大的功能增益的趋势。Piezosurgery 骨设备组患者在 4000Hz 时的 BC 损失约 10dB。组间在 AC 阈值增益和残余气骨间隙方面存在显著差异。由于 BC 阈值略有恶化，Piezosurgery 骨设备组患者在高频时增益较小，残余间隙较大。PZS 组患者术后眩晕发生率也较高。
虽然从统计学角度来看，CO2 激光的使用与标准 MD 鼓膜切开术的结果并无显著差异，但它似乎与最佳功能结果相关。从手术角度来看，PZS 镫骨切开术对大多数患者是有效的。然而，它与高频时 BC 略有但显著恶化以及更高的眩晕发生率相关。为了安全使用这项新技术，需要对刺激参数进行更多的基础验证。
