Lee Seung Won, Son Young-Ik, Kim Chan Hee, Lee Jae Yong, Kim Shi Chan, Koh Yoon Woo
Department of Otolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine, Bucheon, Korea.
Laryngoscope. 2007 Oct;117(10):1871-5. doi: 10.1097/MLG.0b013e3180caa1b1.
Polyacrylamide hydrogel (PAAG, Aquamid) is widely used as permanent facial tissue filler during facial plastic surgery. In this study, we examined the long-term effects and safety aspects of PAAG as a vocal fold augmentation material for patients with permanent unilateral vocal cord paralysis.
Prospective clinical trials.
PAAG injection laryngoplasty was performed in 34 consecutive patients with permanent unilateral vocal cord paralysis. Percutaneous injection was performed under local anesthesia into the vocalis muscle using disposable 25 gauge long needles. Of the 34 patients, 16 completed acoustic, perceptual, stroboscopic, and subjective evaluations prior to the injection and at 6 and 12 months after the injection.
Acoustic and perceptual parameters (GRBAS [Overall grade of dysphonia, Roughness, Breathiness, Aesthenia, Strain], Maximal phonation time [MPT], jitter, and shimmer) were significantly improved (P < .05) after injection and remained stable over 12 months. The grades of mucosal waves and glottic closure were also significantly improved (P < .01). The voice handicap index (VHI), as well as the visual analogue scale (VAS) of hoarseness and aspiration significantly improved over 12 months. No adverse effects were observed except for a decrease in the mucosal wave of one patient, after injection into a superficial area of the vocal fold.
Based on the preliminary results of this trial, PAAG appears to be a long-lasting and safe injection material that is suitable for the treatment of glottal insufficiency caused by permanent unilateral vocal cord paralysis.
聚丙烯酰胺水凝胶(PAAG,奥美定)在面部整形手术中被广泛用作永久性面部组织填充剂。在本研究中,我们研究了PAAG作为永久性单侧声带麻痹患者声带增强材料的长期效果和安全性。
前瞻性临床试验。
对34例连续性永久性单侧声带麻痹患者进行PAAG注射喉成形术。在局部麻醉下,使用一次性25号长针经皮注射到声带肌中。34例患者中,16例在注射前、注射后6个月和12个月完成了声学、感知、频闪喉镜和主观评估。
注射后声学和感知参数(GRBAS [声音障碍总体分级、粗糙声、气息声、无力声、紧张声]、最大发声时间 [MPT]、抖动和闪烁)显著改善(P <.05),并在12个月内保持稳定。黏膜波和声门闭合分级也显著改善(P <.01)。嗓音障碍指数(VHI)以及声音嘶哑和误吸的视觉模拟量表(VAS)在12个月内显著改善。除1例患者在声带浅层区域注射后黏膜波降低外,未观察到不良反应。
基于本试验的初步结果,PAAG似乎是一种持久且安全的注射材料,适用于治疗永久性单侧声带麻痹引起的声门闭合不全。