The Investigation of Hyaluronic Acid (The Chaeum Premium No.2®) to Evaluate the Efficacy and Safety for Injection Laryngoplasty in Unilateral Vocal Cord Paralysis: A Single Center, Phase II Trial
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Background and Objectives This study aimed to evaluate the clinical efficacy and safety of hyaluronic acid (HA) (The Chaeum Premium No.2®) for injection laryngoplasty (IL) in unilateral vocal cord paralysis (UVCP) patients. Materials and Method This clinical trial has been registered with the clinical research information service of the Republic of Korea (No. KCT0007597). Ten patients with UVCP were enrolled. Auditory-perceptual evaluation, acoustic analysis, aerodynamic analysis, electroglottography, laryngoscopy, and voice handicap index (VHI)-30 were assessed before injection, at 1, 3, and 6 months after injection. Results All auditory-perceptual parameters gradually showed statistically significant improvements at 1, 3, and 6 months after injection. Acoustic, aerodynamic parameters, electroglottography, and VHI-30 showed gradual improvements at 1 and 3 months after injection. Then, they showed slight deterioration 6 months after injection. There were no adverse effects in all patients. Conclusion IL using HA is an effective and safe treatment for UVCP patients.
Abstract
Background and Objectives This study aimed to evaluate the clinical efficacy and safety of hyaluronic acid (HA) (The Chaeum Premium No.2®) for injection laryngoplasty (IL) in unilateral vocal cord paralysis (UVCP) patients. Materials and Method This clinical trial has been registered with the clinical research information service of the Republic of Korea (No. KCT0007597). Ten patients with UVCP were enrolled. Auditory-perceptual evaluation, acoustic analysis, aerodynamic analysis, electroglottography, laryngoscopy, and voice handicap index (VHI)-30 were assessed before injection, at 1, 3, and 6 months after injection. Results All auditory-perceptual parameters gradually showed statistically significant improvements at 1, 3, and 6 months after injection. Acoustic, aerodynamic parameters, electroglottography, and VHI-30 showed gradual improvements at 1 and 3 months after injection. Then, they showed slight deterioration 6 months after injection. There were no adverse effects in all patients. Conclusion IL using HA is an effective and safe treatment for UVCP patients.
참고문헌 (25)
- Wang CC, "Hyaluronic acid injection laryngoplasty for unilateral vocal fold paralysis-a systematic review and meta-analysis", Cells, 9(11), pp.2417~ (2020)
- Korean Society of Laryngology, "Guidelines for the management of unilateral vocal fold paralysis from the Korean Society of Laryngology, Phoniatrics and Logopedics", Clin Exp Otorhinolaryngol, 13(4), pp.340~360 (2020)
- Halderman AA, "Safety and length of benefit of restylane for office-based injection medialization-a retrospective review of one institution’s experience", J Voice, 28(5), pp.631~635 (2014)
- Chhetri DK, "Hyaluronic acid for the treatment of vocal fold scars", Curr Opin Otolaryngol Head Neck Surg, 18(6), pp.498~502 (2010)
- Švejdová A, "Injection laryngoplasty with hyaluronic acid for glottal insufficiency in unilateral vocal fold paralysis : a systematic review of the literature", Eur Arch Otorhinolaryngol, 279(11), pp.5071~5079 (2022)
- Hertegård S, "Cross-linked hyaluronan used as augmentation substance for treatment of glottal insufficiency : safety aspects and vocal fold function", Laryngoscope, 112(12), pp.2211~2219 (2002)
- Miaśkiewicz B, "Comparison of 24-month voice outcomes after injection laryngoplasty with calcium hydroxylapatite or hyaluronic acid in patients with unilateral vocal fold paralysis", Am J Otolaryngol, 43(1), pp.103207~ (2022)
- Kang MG, "Effects of percutaneous injection laryngoplasty on voice and swallowing problems in cancer-related unilateral vocal cord paralysis", Laryngoscope Investig Otolaryngol, 6(4), pp.800~806 (2021)
- Pei YC, "Voice aerodynamics following office-based hyaluronate injection laryngoplasty", Clin Otolaryngol, 44(4), pp.594~602 (2019)
- Bertroche JT, "Patient-defined duration of benefit from juvederm(hyaluronic acid)used in injection laryngoplasty", Laryngoscope, 129(12), pp.2744~2747 (2019)
- Pei YC, "Early hyaluronate injection improves quality of life but not neural recovery in unilateral vocal fold paralysis : an open-label randomized controlled study", Restor Neurol Neurosci, 33(2), pp.121~130 (2015)
- Wen MH, "Treatment outcomes of injection laryngoplasty using cross-linked porcine collagen and hyaluronic acid", Otolaryngol Head Neck Surg, 149(6), pp.900~906 (2013)
- Upton DC, "Prospective evaluation of office-based injection laryngoplasty with hyaluronic acid gel", Ann Otol Rhinol Laryngol, 122(9), pp.541~546 (2013)
- Oguz H, "Long-term voice results of injection with hyaluronic acid-dextranomere in unilateral vocal fold paralysis", Acta Otolaryngol, 133(5), pp.513~517 (2013)
- Reiter R, "Laryngoplasty with hyaluronic acid in patients with unilateral vocal fold paralysis", J Voice, 26(6), pp.785~791 (2012)
- Lau DP, "Injection laryngoplasty with hyaluronic acid for unilateral vocal cord paralysis. Randomized controlled trial comparing two different particle sizes", J Voice, 24(1), pp.113~118 (2010)
- Lovato A, "Predicting the outcome of unilateral vocal fold paralysis : a multivariate discriminating model including grade of dysphonia, jitter, shimmer, and voice handicap index-10", Ann Otol Rhinol Laryngol, 128(5), pp.447~452 (2019)
- Spector BC, "Quality-of-life assessment in patients with unilateral vocal cord paralysis", Otolaryngol Head Neck Surg, 125(3), pp.176~182 (2001)
- White M, "Laboratory evaluation of vocal fold paralysis and paresis", J Voice, 31(2), pp.168~174 (2017)
- Balasubramanium RK, "Cepstral analysis of voice in unilateral adductor vocal fold palsy", J Voice, 25(3), pp.326~329 (2011)
- Valentino WL, "Diagnostic value of acoustic and aerodynamic measurements in vocal fold movement disorders and their correlation with laryngeal electromyography and voice handicap index", J Voice, 35(3), pp.497~ (2021)
- Guzmán M, "Air pressure and contact quotient measures during different semioccluded postures in subjects with different voice conditions", J Voice, 30(6), pp.759~ (2016)
- Lee SW, "Utility of injection laryngoplasty in the management of post-thyroidectomy vocal cord paralysis", Thyroid, 20(5), pp.513~517 (2010)
- Lee W, "Practical guidelines for hyaluronic acid soft-tissue filler use in facial rejuvenation", Dermatol Surg, 46(1), pp.41~49 (2020)
- Mallur PS, "Vocal fold injection : review of indications, techniques, and materials for augmentation", Clin Exp Otorhinolaryngol, 3(4), pp.177~182 (2010)