Jost Wolfgang H, Steffen Armin, Berweck Steffen
Parkinson-Klinik Ortenau, Wolfach, Germany.
Department for Otorhinolaryngology, University of Lübeck, Lübeck, Germany.
Expert Rev Neurother. 2021 Oct;21(10):1059-1068. doi: 10.1080/14737175.2021.1979959. Epub 2021 Oct 4.
Sialorrhea, also known as hypersalivation, ptyalis, or drooling, results in physical and psychosocial complications that may have a significant negative impact on quality of life for both the patient and their caregiver. The goal of pharmacological treatment is to reduce excessive salivary flow, while maintaining a moist and healthy oral cavity; until recently, however, few of the agents used to treat chronic sialorrhea have been approved in pediatric patients.
This article summarizes early evidence for the use of botulinum neurotoxin A formulations in the treatment of children/adolescents with chronic sialorrhea, and findings of the recently completed phase III trial of incobotulinumtoxinA in this indication. Alternative therapies are also briefly discussed.
IncobotulinumtoxinA is the first botulinum neurotoxin A to be approved for the treatment of chronic sialorrhea in children and adults, following the results of phase III trials that demonstrate the efficacy and safety of the drug in these patients. The authors expect that the positive findings will result in updates to clinical guidelines for the treatment of children with chronic sialorrhea.
AE, adverse event; AESI, adverse event of special interest; BoNT/A, botulinum neurotoxin A; CI, confidence interval; CP, cerebral palsy; DIS, drooling impact scale; DQ, drooling quotient; DSFS, Drooling Severity and Frequency Scale; GICS, Global Impression of Change Scale; LS, least squares; mTDS, modified Teacher's drooling scale; NR, not reported; PD, Parkinson's disease; SAE, serious adverse event; SE, standard error; SIAXI, Sialorrhea in Adults Xeomin Investigation; SIPEXI, Sialorrhea Pediatric Xeomin Investigation; SNAP-25, synaptosomal associated protein-25; TBI, traumatic brain injury; TDS, Teacher Drooling Scale; USA, United States of America; uSFR, unstimulated Salivary Flow Rate; VAS, visual analog scale.
流涎症，也称为唾液分泌过多、唾液溢或流口水，会导致身体和心理社会并发症，可能对患者及其护理人员的生活质量产生重大负面影响。药物治疗的目标是减少过多的唾液分泌，同时保持口腔湿润和健康；然而，直到最近，用于治疗慢性流涎症的药物中，很少有在儿科患者中获得批准的。
本文总结了使用A型肉毒杆菌神经毒素制剂治疗儿童/青少年慢性流涎症的早期证据，以及最近完成的incobotulinumtoxinA在该适应症的III期试验结果。还简要讨论了替代疗法。
根据III期试验结果证明该药物在儿童和成人中的疗效和安全性后，incobotulinumtoxinA是首个被批准用于治疗儿童和成人慢性流涎症的A型肉毒杆菌神经毒素。作者预计，这些阳性结果将导致慢性流涎症儿童治疗临床指南的更新。
AE，不良事件；AESI，特殊关注不良事件；BoNT/A，A型肉毒杆菌神经毒素；CI，置信区间；CP，脑瘫；DIS，流口水影响量表；DQ，流口水商数；DSFS，流口水严重程度和频率量表；GICS，总体变化印象量表；LS，最小二乘法；mTDS，改良教师流口水量表；NR，未报告；PD，帕金森病；SAE，严重不良事件；SE，标准误差；SIAXI，成人西妥昔单抗流涎症研究；SIPEXI，儿科西妥昔单抗流涎症研究；SNAP-25，突触体相关蛋白-25；TBI，创伤性脑损伤；TDS，教师流口水量表；美国，美利坚合众国；uSFR，非刺激性唾液流速；VAS，视觉模拟量表。
