Department of Otolaryngology-Head and Neck Surgery, The Pennsylvania State University, Milton S. Hershey Medical Center, Hershey, PA, USA.
The Pennsylvania State University, College of Medicine, Hershey, PA, USA.
Ann Otol Rhinol Laryngol. 2023 Feb;132(2):200-206. doi: 10.1177/00034894221078365. Epub 2022 Feb 18.
Botulinum toxin A is known to be effective and safe in managing sialorrhea in pediatric patients; however, there is no consensus on a protocol for optimal injection sites and appropriate dosing for injection.
This review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol. PubMed, EMBASE, and other databases were queried to identify articles that evaluated botulinum toxin type A for the treatment of sialorrhea in the pediatric population. A total of 405 studies were identified. After applying inclusion and exclusion criteria, 31 articles were included for review.
A total of 14 studies evaluated 2-gland injections, and 17 studies evaluated 4-gland injections. Of the 31 studies included, one study assessed incobotulinumtoxinA (Xeomin) the remaining all used onabotulinumtoxinA (Botox). For 2-gland injection studies, a combined total of 899 participants were reviewed, where 602 participants received 50 units into their submandibular glands, while 262 participants received 30 to 50 units. Among 4-gland injection studies, there was a combined total of 388 participants, with the most prevalent dosage utilized being 60 to 100 units in 230 participants, followed by 100 units total in 77 participants. The most common adverse event was dysphagia which resolved in nearly all cases. Three studies aimed to examine 2-gland versus 4-gland injections, with 2 of the studies concluding 4-gland injection was superior.
The strength of evidence suggests that the dosing of 50 units total of onabotulinumtoxinA to the submandibular glands is safe and effective in the pediatric population. For 4-gland injections, bilateral submandibular and parotid gland injections of 60 to 100 units total is the safe and effective dosage. There is no substantial evidence comparing 4-gland injections to 2-gland injections, but research thus far suggests 4-gland injections to be superior. Future study is needed to evaluate incobotulinumtoxinA and abobotulinumtoxinA dosages in the pediatric population.
肉毒毒素 A 已被证实可有效且安全地治疗儿科患者的流涎症,但对于最佳注射部位和注射剂量的方案尚未达成共识。
本综述按照系统评价和荟萃分析的 Preferred Reporting Items 进行。通过检索 PubMed、EMBASE 和其他数据库,以确定评估肉毒毒素 A 治疗儿科人群流涎症的文章。共确定了 405 项研究。在应用纳入和排除标准后,纳入了 31 项研究进行综述。
共有 14 项研究评估了 2 腺注射,17 项研究评估了 4 腺注射。在纳入的 31 项研究中,有 1 项研究评估了 incobotulinumtoxinA(Xeomin),其余均使用了 onabotulinumtoxinA(Botox)。对于 2 腺注射研究,共评估了 899 名参与者,其中 602 名参与者在其下颌下腺中接受了 50 个单位的注射,而 262 名参与者接受了 30 至 50 个单位的注射。在 4 腺注射研究中,共评估了 388 名参与者,其中最常见的剂量是 230 名参与者中 60 至 100 个单位,其次是 77 名参与者中总共 100 个单位。最常见的不良事件是吞咽困难,几乎所有患者的吞咽困难都得到了缓解。有 3 项研究旨在比较 2 腺与 4 腺注射,其中 2 项研究得出结论认为 4 腺注射更优。
现有证据表明,在儿科人群中,安全且有效的剂量为总剂量 50 个单位的 onabotulinumtoxinA 注射至下颌下腺。对于 4 腺注射,双侧下颌下腺和腮腺注射总剂量 60 至 100 个单位是安全且有效的剂量。目前尚无比较 4 腺注射与 2 腺注射的大量证据,但迄今为止的研究表明 4 腺注射更优。需要进一步研究评估 incobotulinumtoxinA 和 abobotulinumtoxinA 在儿科人群中的剂量。