Cha Wonjae, Jang Jeon Yeob, Wang Soo-Geun, Kang Ji-Heon, Jo Min-Gyu
Department of Otorhinolaryngology-Head and Neck Surgery and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea; Department of Otorhinolaryngology-Head and Neck Surgery, Pusan National University School of Medicine, Yangsan, Republic of Korea.
Department of Otorhinolaryngology-Head and Neck Surgery and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.
J Voice. 2017 May;31(3):378.e19-378.e24. doi: 10.1016/j.jvoice.2016.07.004. Epub 2016 Aug 9.
Botulinum toxin (BTX) has been widely used to treat adductor spasmodic dysphonia (ADSD). Most commercially available forms of BTX require reconstitution before use, which may increase the risk of contamination and requires careful titration. Recently, a liquid-type BTX type A (BTX-A) has been developed, which should simplify the procedure and enhance its efficacy. Herein, we present a prospective pilot study to investigate the efficacy and safety of liquid-type BTX-A in the treatment of ADSD.
Twenty-six consecutive liquid-type BTX-A injections were performed in 12 patients with ADSD. We included as a control group 34 consecutive patients with ADSD who had previously undergone 52 vocal fold injection procedures with freeze-dried-type BTX-A.
All patients in both groups had improvement of symptoms related to ADSD and period of normal voice. Most patients experienced breathiness, and the onset time, the peak response time, and the duration of breathiness were similar in both groups. The duration of effect (days) was 96.96 ± 18.91 and 77.38 ± 18.97 in the freeze-dried-type and the liquid-type groups, and the duration of benefit (days) was 80.02 ± 18.24 and 62.69 ± 19.73 in the freeze-dried-type and the liquid-type groups. To compare the efficacy between the freeze-dried-type and the liquid-type BTX-A, the sessions of the unilateral vocal fold injection were included and were categorized as group A (1 ~ 2 units BTX-A) and group B (2 ~ 3 units BTX-A), according to the dose per vocal fold. There was no significant difference of effect time between freeze-dried-type and liquid-type BTX-A groups. No adverse events related to BTX or vocal fold injection were reported.
Liquid-type BTX-A is safe and effective for the treatment of spasmodic dysphonia. With the advantages of simple preparation, storage, and reuse and animal protein-free constituents, liquid-type BTX-A may be a good option in the treatment of spasmodic dysphonia.
肉毒杆菌毒素(BTX)已被广泛用于治疗内收性痉挛性发声障碍(ADSD)。大多数市售的BTX制剂在使用前需要重新配制,这可能会增加污染风险,并且需要仔细滴定。最近,一种液体型A型肉毒杆菌毒素(BTX-A)已被研发出来,这有望简化治疗程序并提高其疗效。在此,我们开展一项前瞻性试验研究,以调查液体型BTX-A治疗ADSD的疗效和安全性。
对12例ADSD患者连续进行了26次液体型BTX-A注射。我们纳入了34例连续的ADSD患者作为对照组,这些患者此前接受过52次冻干型BTX-A声带注射治疗。
两组所有患者与ADSD相关的症状均有改善,嗓音正常时间延长。大多数患者出现了声嘶,两组的声嘶起始时间、峰值反应时间和声嘶持续时间相似。冻干型组和液体型组的作用持续时间(天)分别为96.96±18.91和77.38±18.97,获益持续时间(天)分别为80.02±18.24和62.69±19.73。为比较冻干型和液体型BTX-A的疗效,纳入单侧声带注射疗程,并根据每侧声带的剂量分为A组(12单位BTX-A)和B组(23单位BTX-A)。冻干型和液体型BTX-A组之间的起效时间无显著差异。未报告与BTX或声带注射相关的不良事件。
液体型BTX-A治疗痉挛性发声障碍安全有效。液体型BTX-A具有制备、储存和再利用简单以及无动物蛋白成分等优点,可能是治疗痉挛性发声障碍的一个良好选择。