From the Department of Otorhinolaryngology and Head and Neck Surgery (S.B., C.P.D., S.E.K., A.R.T.S., F.J.A.v.d.H.), Radboud University Medical Centre, Nijmegen; and Departments of Rehabilitation (K.v.H.) and Paediatric Neurology (C.E.E.), Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.
Neurology. 2019 Mar 12;92(11):e1195-e1204. doi: 10.1212/WNL.0000000000007081. Epub 2019 Feb 6.
To compare the effect of submandibular duct ligation (2-DL) and submandibular botulinum neurotoxin type A (BoNT-A) for drooling in children and adolescents with neurodevelopmental disabilities.
A randomized, interventional, controlled, and partly single-blinded study was performed in which submandibular BoNT-A was compared with 2-DL to treat excessive drooling. Main outcomes included a Visual Analog Scale (VAS), drooling quotient (DQ), drooling severity (DS) scale and drooling frequency (DF) scale. Each was obtained at baseline, and 8 and 32 weeks post treatment.
Fifty-seven patients (mean age: 11 years, mean baseline VAS score 7.9, mean baseline DQ 27.3%) were randomized to the 2-DL or BoNT-A group. Four patients were excluded from analyses, leaving 53 patients for intention-to-treat analyses. Response to treatment, defined as a ≥50% reduction in DQ or VAS score, was higher for 2-DL after 32 weeks (63.0% vs 26.9%, = 0.008). Both VAS score (24.5, < 0.001) and DQ (-9.3%, = 0.022) were significantly lower at follow-up after 2-DL vs BoNT-A. The total number of adverse events ( = 0.088, 40.7% vs 19.2%) and postoperative complaints was higher ( < 0.001, mean 9.6 vs 3.6 days) for 2-DL than for BoNT-A.
The 2-DL procedure is a more effective treatment for drooling than botulinum toxin, but carries a slightly greater risk of complications and morbidity.
NTR3537.
This study provides Class III evidence that for children and adolescents with neurodevelopmental disabilities and severe drooling, 2-DL compared to a one-time intraglandular BoNT-A injection is more effective at reducing drooling at 32 weeks.
比较下颌下腺导管结扎术（2-DL）和下颌下肉毒毒素 A（BoNT-A）治疗神经发育障碍儿童和青少年流涎的效果。
这是一项随机、干预性、对照和部分单盲研究，比较了下颌下 BoNT-A 与 2-DL 治疗过度流涎。主要结局包括视觉模拟量表（VAS）、流涎量（DQ）、流涎严重程度（DS）评分和流涎频率（DF）评分。在基线时和治疗后 8 周和 32 周时分别获得这些评分。
57 例患者（平均年龄：11 岁，平均基线 VAS 评分 7.9，平均基线 DQ 27.3%）被随机分配至 2-DL 或 BoNT-A 组。有 4 例患者被排除在分析之外，53 例患者进行意向治疗分析。治疗反应定义为 DQ 或 VAS 评分降低≥50%，2-DL 组在 32 周时更高（63.0%比 26.9%， = 0.008）。与 BoNT-A 相比，2-DL 组在随访时 VAS 评分（24.5， < 0.001）和 DQ（-9.3%， = 0.022）均显著降低。2-DL 组的不良事件总发生率（ = 0.088，40.7%比 19.2%）和术后抱怨（ < 0.001，平均 9.6 天比 3.6 天）均高于 BoNT-A 组。
与肉毒毒素相比，2-DL 手术是一种更有效的流涎治疗方法，但并发症和发病率略高。
NTR3537。
这项研究提供了 III 级证据，表明对于患有神经发育障碍和严重流涎的儿童和青少年，与单次下颌下腺内 BoNT-A 注射相比，2-DL 治疗在 32 周时更能有效减少流涎。
