Department of Maxillofacial Surgery, St. Olavs University Hospital, Trondheim, Norway.
Department of Neuromedicine and Movement Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.
Acta Otolaryngol. 2021 Oct;141(10):934-940. doi: 10.1080/00016489.2021.1982146. Epub 2021 Oct 11.
The main objective of this prospective, open, uncontrolled pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in 10 patients with refractory chronic rhinosinusitis with nasal polyposis (CRSwNP) using a novel injection tool, the MultiGuide.
A one-month baseline period was followed by bilateral injections of 25 U BTA in the SPG and a follow-up of 12 weeks. The primary outcome was adverse events (AE), and the main efficacy outcome was a 50% reduction in visual analogue scale (VAS) symptoms for nasal obstruction and rhinorrhea in months 2 and 3 post-treatment compared to baseline.
We registered 13 AEs, none of which were serious, however, one patient experienced diplopia which moderately affected his daily activities. The symptoms slowly improved and resolved 4 weeks after injection. Five patients were treatment responders with at least 50% median reduction in the nasal obstruction, and four were treatment responders concerning rhinorrhea.
Injection of BTA toward the SPG using the MultiGuide in patients with CRSwNP appears to be safe but with a potential for moderately disabling side effects. The study indicates a beneficial effect on nasal obstruction.
本前瞻性、开放、非对照的初步研究的主要目的是使用新型注射工具 MultiGuide,调查 10 例难治性慢性鼻-鼻窦炎伴鼻息肉(CRSwNP)患者接受眶下神经节(SPG)注射肉毒毒素 A(BTA)的安全性。
在基线期 1 个月后,对双侧 SPG 进行 25U BTA 注射,并进行 12 周的随访。主要结局是不良事件(AE),主要疗效结局是与基线相比,治疗后第 2 和第 3 个月 VAS 症状(鼻塞和流涕)的 50%减轻。
我们记录了 13 例不良事件,均不严重,但 1 例患者出现复视,中度影响日常生活活动。症状缓慢改善,在注射后 4 周内缓解。5 例患者为治疗应答者,鼻塞的中位数至少减轻了 50%,4 例患者为治疗应答者,流涕情况得到改善。
使用 MultiGuide 向 SPG 注射 BTA 似乎对 CRSwNP 患者是安全的,但可能会产生中度致残的副作用。该研究表明对鼻塞有有益的效果。