蚕丝透明质酸治疗声门水肿的安全性和有效性的初步结果

IF 2.5 4区医学 Q1 AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY

Journal of Voice Pub Date : 2025-05-01 DOI:10.1016/j.jvoice.2022.11.009

Christopher D. Dwyer , Elliana Devore , Samantha Kridgen , Douglas Roth , Jennifer Winston , Thomas L. Carroll

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引用次数: 0

摘要

目的：蚕丝透明质酸（Silk-HA）是一种新型声带褶皱增厚材料，自 2020 年 7 月起开始用于人体。有关 Silk-HA 的公开数据很少，而且其使用寿命仍是一个问题。本研究旨在评估一名外科医生实施 Silk-HA 注射喉成形术治疗声门发育不全的初步经验：对 2020 年 7 月至 2021 年 12 月期间的 Silk-HA 注射进行回顾性病历审查。收集受试者的人口统计数据、诊断、注射材料量、VHI-10 数据和并发症。由两名嗓音专业的语言病理学家（SLP）对单侧声带麻痹患者在注射丝-HA 前和注射后 3 个月的嗓音样本进行盲法嗓音感知分析。对随访 3 个月时 VHI-10 和感知语音分析的变化进行了单变量评估：58 名患者（43.1% 为女性）接受了丝-HA 注射，平均年龄为 64 岁（21-88 岁不等）。38 名受试者单侧瘫痪（65.6%），其余受试者有疤痕、萎缩、瘫痪或混合症状。49 例为单侧注射（84.5%）。平均注射丝量为 0.26 毫升。并发症很少，最显著的并发症是 2 例因呼吸困难和喉镜显示半喉水肿而入院的患者（3.4%）。CAPE-V总体严重程度评分的平均变化为-32.9（PC结论：Silk-HA的初步结果显示，自扩容之日起3个月后，声门功能不全仍有可能得到持续改善。临床医生和患者对嗓音效果的感知显示，三个月后嗓音效果总体有所改善，但持续时间仍有待确定。虽然总体上耐受性良好，96%的患者未出现严重并发症，但应告知患者可能出现气道水肿和症状性呼吸困难，需要类固醇治疗和观察。

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Preliminary Results on the Safety and Efficacy of Silk-Hyaluronic Acid for Treatment of Glottic Insufficiency

Objectives

Silk-Hyaluronic Acid (Silk-HA) is a novel vocal fold augmentation material that has been used in humans since July 2020. There is a paucity of published data on Silk-HA and its longevity remains a question. This study aimed to evaluate a single surgeon's initial experience performing Silk-HA injection laryngoplasty for the treatment of glottic insufficiency.

Methods

Retrospective chart review of Silk-HA injections between July 2020 and December 2021. Subject demographics, diagnoses, volume of material injected, VHI-10 data, and complications were collected. A blinded perceptual voice analysis of voice samples was performed by two voice-specialized speech-language pathologists (SLP) for a subset of unilateral vocal fold paralysis patients before and 3-months following silk-HA injection. Univariate assessment of the change in VHI-10 and perceptual voice analyses at 3-month follow up was determined.

Results

58 patients (43.1% female) underwent Silk-HA injection with a mean age of 64 (range 21-88). 38 subjects had unilateral paralysis (65.6%), and the remaining had scar, atrophy, paresis or a combination thereof. 49 injections were unilateral (84.5%). Mean volume of silk injected was 0.26 mL. Complications were rare, most notable though for 2 admissions for dyspnea and laryngoscopic evidence of hemi-laryngeal edema (3.4%). Mean change in CAPE-V overall severity rating was -32.9 (P<0.0001), and VHI-10 was -14.6 ± 10 (P=0.0013). 14 patients underwent a repeat silk-HA injection for ongoing glottic insufficiency (loss of augmentation vs under-augmentation).

Conclusions

Preliminary results for Silk-HA show potential for ongoing improvement of glottic insufficiency at 3 months from date of augmentation. Clinician and patient perception of voice outcomes showed overall improvement at three months, though longevity remains to be determined. While overall well tolerated and without serious complications in 96% of the cohort, patients should be counseled on the potential for airway edema and symptomatic dyspnea requiring steroid management and observation.

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来源期刊

Journal of Voice 医学-耳鼻喉科学

CiteScore

4.00

自引率

13.60%

发文量

395

审稿时长

59 days

期刊介绍： The Journal of Voice is widely regarded as the world''s premiere journal for voice medicine and research. This peer-reviewed publication is listed in Index Medicus and is indexed by the Institute for Scientific Information. The journal contains articles written by experts throughout the world on all topics in voice sciences, voice medicine and surgery, and speech-language pathologists'' management of voice-related problems. The journal includes clinical articles, clinical research, and laboratory research. Members of the Foundation receive the journal as a benefit of membership.