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依库珠单抗毒素 A(Xeomin)治疗内收性喉痉挛:一项前瞻性、开放标签临床试验。

IncobotulinimtoxinA (Xeomin) for the treatment of adductor laryngeal dystonia: A prospective, open-label clinical trial.

机构信息

Department of Surgery, Division of Otolaryngology, Yale University School of Medicine, New Haven, CT, United States of America.

Department of Surgery, Division of Otolaryngology, Yale University School of Medicine, New Haven, CT, United States of America.

出版信息

Am J Otolaryngol. 2022 Nov-Dec;43(6):103613. doi: 10.1016/j.amjoto.2022.103613. Epub 2022 Aug 27.

DOI:10.1016/j.amjoto.2022.103613
PMID:36055061
Abstract

OBJECTIVES

Demonstrate an understanding of incobotulinumtoxinA efficacy in the treatment of adductor spasmodic dysphonia (SD). Understand that incobotulinumtoxinA can successfully be used as an alternative to onabotulinumtoxinA and for secondary non-responders.

METHODS

We conducted a prospective open-label trial from 2016 until 2019 regarding the use of incobotulinimtoxinA for the treatment of adductor spasmodic dysphonia. Exclusion criteria included pregnant/nursing women, botulinum toxin for other indications, known allergy, neuromuscular or systemic diseases, use of aminoglycoside antibiotics, substance abuse, litigation regarding prior therapy, or other confounding conditions. Sixty-four injection sessions with completed with sixteen patients who were enrolled in the study and underwent EMG-guided incobotulinumtoxinA injections to the thyroarytenoid (TA) muscle using a hollow monopolar Teflon-coated needle via a trans-cricothyroid membrane approach. Dosages to each TA muscle were recorded and patients completed a Voice Handicap Index-10 (VHI-10), a validated worksheet regarding their perceived percent of normal function (PNF) following treatment, and a side effect profile. Outcomes were analyzed using the paired t-test.

RESULTS

For primary transitioners to incobotulinimtoxinA, VHI-10 scores and best percent normal function did not significantly change. For non-responders, VHI-10 decreased from 32.5 on Botox to 19.5 on incobotulinimtoxinA and best PNF increased from 37.6 to 90 %, which was statistically significant. Transient side effects included breathiness.

CONCLUSIONS

Our study demonstrates that incobotulinimtoxinA may be used successfully for adductor SD either as first line treatment or in secondary non-responders to onabotulinumtoxinA.

摘要

目的

展示英博利单抗毒素 A 在治疗内收肌痉挛性发音障碍 (SD) 中的疗效。了解英博利单抗毒素 A 可以成功替代肉毒毒素 A 并用于二次无应答者。

方法

我们进行了一项从 2016 年到 2019 年的前瞻性开放标签试验,研究英博利单抗毒素 A 治疗内收肌痉挛性发音障碍的用途。排除标准包括孕妇/哺乳期妇女、用于其他适应症的肉毒毒素、已知过敏、神经肌肉或系统性疾病、使用氨基糖苷类抗生素、药物滥用、与先前治疗有关的诉讼或其他混杂情况。16 名患者完成了 64 次注射疗程,这些患者参加了这项研究,并通过经环甲膜的方法使用空心单极聚四氟乙烯涂层针在甲状软骨肌和杓状软骨肌(TA)肌内接受英博利单抗毒素 A 的肌电图引导注射。记录了每个 TA 肌肉的剂量,患者完成了嗓音障碍指数-10(VHI-10)、一份关于他们在治疗后感知正常功能百分比(PNF)的经过验证的工作表,以及一份副作用概况。使用配对 t 检验分析结果。

结果

对于初次转为英博利单抗毒素 A 的患者,VHI-10 评分和最佳 PNF 没有显著变化。对于无应答者,VHI-10 从博妥珠单抗的 32.5 降至英博利单抗毒素 A 的 19.5,最佳 PNF 从 37.6 增至 90%,这具有统计学意义。短暂的副作用包括呼吸急促。

结论

我们的研究表明,英博利单抗毒素 A 可成功用于治疗内收肌 SD,无论是作为一线治疗还是作为对博妥珠单抗的二次无应答者。

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