Blackshaw Helen, Carding Paul, Jepson Marcus, Mat Baki Marina, Ambler Gareth, Schilder Anne, Morris Stephen, Degun Aneeka, Yu Rosamund, Husbands Samantha, Knowles Helen, Walton Chloe, Karagama Yakubu, Heathcote Kate, Birchall Martin
Ear Institute, University College London, London, UK.
School of Allied Health, Australian National Catholic University, North Sydney, New South Wales, Australia.
BMJ Open. 2017 Sep 29;7(9):e016871. doi: 10.1136/bmjopen-2017-016871.
A functioning voice is essential for normal human communication. A good voice requires two moving vocal folds; if one fold is paralysed (unilateral vocal fold paralysis (UVFP)) people suffer from a breathy, weak voice that tires easily and is unable to function normally. UVFP can also result in choking and breathlessness. Current treatment for adults with UVFP is speech therapy to stimulate recovery of vocal fold (VF) motion or function and/or injection of the paralysed VF with a material to move it into a more favourable position for the functioning VF to close against. When these therapies are unsuccessful, or only provide temporary relief, surgery is offered. Two available surgical techniques are: (1) surgical medialisation; placing an implant near the paralysed VF to move it to the middle (thyroplasty) and/or repositioning the cartilage (arytenoid adduction) or (2) restoring the nerve supply to the VF (laryngeal reinnervation). Currently there is limited evidence to determine which surgery should be offered to adults with UVFP.
A feasibility study to test the practicality of running a multicentre, randomised clinical trial of surgery for UVFP, including: (1) a qualitative study to understand the recruitment process and how it operates in clinical centres and (2) a small randomised trial of 30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty. Participants will be followed up for 12 months. The primary outcome focuses on recruitment and retention, with secondary outcomes covering voice, swallowing and quality of life.
Ethical approval was received from National Research Ethics Service-Committee Bromley (reference 11/LO/0583). In addition to dissemination of results through presentation and publication of peer-reviewed articles, results will be shared with key clinician and patient groups required to develop the future large-scale randomised controlled trial.
ISRCTN90201732; 16 December 2015.
正常发声对于人类正常交流至关重要。良好的嗓音需要两条可活动的声带；如果一条声带麻痹（单侧声带麻痹（UVFP）），人们会出现嗓音沙哑、微弱，容易疲劳且无法正常发声的情况。单侧声带麻痹还可能导致呛噎和呼吸急促。目前针对成年单侧声带麻痹患者的治疗方法包括言语治疗以刺激声带（VF）运动或功能的恢复，和/或向麻痹的声带注射一种材料，使其移动到更有利于功能正常的声带闭合的位置。当这些治疗方法无效或仅提供暂时缓解时，则会考虑手术治疗。两种可用的手术技术是：（1）手术内移术；在麻痹的声带附近放置植入物将其移至中间位置（甲状成形术）和/或重新定位软骨（杓状软骨内收术），或（2）恢复声带的神经供应（喉再神经化）。目前，对于成年单侧声带麻痹患者应选择哪种手术治疗，证据有限。
一项可行性研究，旨在测试开展一项针对单侧声带麻痹手术的多中心随机临床试验的实用性，包括：（1）一项定性研究，以了解招募过程及其在临床中心的运作方式，以及（2）一项在英国3个地点招募30名参与者的小型随机试验，比较非选择性喉再神经化与I型甲状成形术。参与者将接受为期12个月的随访。主要结局关注招募和保留情况，次要结局包括嗓音、吞咽和生活质量。
已获得国家研究伦理服务委员会布罗姆利委员会的伦理批准（参考编号11/LO/0583）。除了通过报告和发表同行评审文章来传播结果外，还将与开展未来大规模随机对照试验所需的关键临床医生和患者群体分享结果。
ISRCTN90201732；2015年12月16日。
