Department of Otorhinolaryngology-Head and Neck Surgery, Pusan National University Hospital, Busan, South Korea.
Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea.
Clin Otolaryngol. 2021 Sep;46(5):998-1004. doi: 10.1111/coa.13767. Epub 2021 Apr 27.
Sialocele and salivary fistula are not serious but troublesome complications after parotidectomy. Various modalities have been introduced to prevent postoperative saliva-related complications. However, clinical trials assessing the prophylactic use of botulinum toxin (BTX) for parotidectomy have not been conducted yet. Herein, we report a pilot study investigating the safety and efficacy of intraoperative BTX (iBTX) injection in partial superficial parotidectomy (PSP).
Patients with benign parotid tumour were prospectively recruited for this clinical trial from 2017 to 2019. The study participants underwent PSP with iBTX injection. We retrospectively reviewed the clinical information of all the consecutive patients who underwent PSP without iBTX from 2013 to 2019. These patients were divided into two groups: the iBTX group (n = 36) and the control group (n = 54).
Permanent facial palsy was not observed in either group. Two patients (3.7%) had transient marginal palsy in the control group but none had it in the iBTX group. The incidence of sialocele was significantly lower in the iBTX group than in the control group (2.8% vs. 20.4%, P < .05). Although the incidence of salivary fistula was lower in the iBTX group than in the control group (0% vs. 7.4%), no significant difference was determined between the two groups (P = .147). Total drainage volume was significantly lower in the iBTX group than in the control group (55.0 mL vs. 116.6 mL, P < .001).
iBTX injection may be safe and effective in reducing sialocele and postoperative drainage in PSP. It might be a useful option to prevent saliva-related complications after PSP.
涎瘘和涎肿虽不是腮腺切除术后严重但却很麻烦的并发症，但各种方法已被引入以预防术后与唾液相关的并发症。然而，尚未进行评估肉毒毒素（BTX）在腮腺切除术预防性使用的临床试验。在此，我们报告了一项关于术中 BTX（iBTX）注射在腮腺部分浅叶切除术中（PSP）中安全性和有效性的初步研究。
本临床试验前瞻性地从 2017 年至 2019 年招募了患有良性腮腺肿瘤的患者。这些患者接受了 iBTX 注射的 PSP。我们回顾性分析了所有 2013 年至 2019 年期间未接受 iBTX 的连续 PSP 患者的临床资料。这些患者分为 iBTX 组（n=36）和对照组（n=54）。
两组均未观察到永久性面瘫。对照组有 2 例（3.7%）出现暂时性边缘性面瘫，而 iBTX 组无此情况。iBTX 组涎肿的发生率明显低于对照组（2.8%比 20.4%，P<.05）。虽然 iBTX 组的涎瘘发生率低于对照组（0%比 7.4%），但两组之间无显著差异（P=0.147）。iBTX 组的总引流量明显低于对照组（55.0 mL 比 116.6 mL，P<.001）。
iBTX 注射可能安全有效，可减少 PSP 术后涎肿和引流。对于预防 PSP 后与唾液相关的并发症，这可能是一种有用的选择。
