Gonzalez-L Maria D, Martinez Carmen, Bori Y Fortuny Inma, Suso-Vergara Santiago
From the Vall d'Hebron University Hospital, Barcelona, Spain (MDG-L, CM, IBF); and University Clinic Hospital, Villarroel, Barcelona, Spain (SS-V).
Am J Phys Med Rehabil. 2017 Feb;96(2):68-76. doi: 10.1097/PHM.0000000000000525.
To assess the efficacy and safety of botulinum toxin A (BoNT-A) injected in both submandibular and parotid versus only in parotid glands as a treatment for drooling in patients with spastic and dyskinetic cerebral palsy (CP), including an assessment of impact on quality of life (QoL) based on items from the International Classification of Functioning, Disability, and Health (ICF) core set.
Forty patients with CP 18 years or older (mean, 21.8 years) participated in a prospective, single-center, randomized controlled interventional study. All participants were classified as Gross Motor Function Classification System level III or higher and all had significant drooling as defined in prior studies. One group (group A) was treated with 100 U of BoNT-A, and another group (group B) served as control. In the treatment group, all patients first received combined parotid and submandibular injections, and then parotid injections only. The main outcome variables were a postinjection decrease in the drooling quotient (DQ) of 50% or more, total flow of 30% or more, and QoL as assessed by a set of 10 items related to drooling from the ICF.
The proportion of patients who achieved at least 50% reduction in DQ was 45% in group A versus 0.0% in group B; 0.0% (P = 0.0012); and of those who achieved at least 30% reduction in total flow was 90% in group A versus 10% in group B (P < 0.0001). Within group A, 42.1% of the dyskinetic patients versus 58.0% of the spastic ones showed 50% or better response in DQ, which is not a statistically significant difference (P = 0.8045). With regard to ICF questions, group A showed statistically significant improvements in several related items. There did not seem to be a significant difference in overall response for providing parotid-only injections. Additional correlations and uncommon adverse effect experiences are also reviewed.
Botulinum toxin A injection of the salivary glands is frequently effective and generally safe for the treatment of drooling in patients with either spastic or dyskinetic CP, both in objective measurement of saliva production and subjective symptoms related to the condition. There does not seem to be a significant advantage of injecting both submandibular and parotid glands over injecting parotid glands alone.
评估在患有痉挛型和运动障碍型脑瘫（CP）的患者中，将A型肉毒毒素（BoNT-A）注射到下颌下腺和腮腺与仅注射到腮腺治疗流涎的疗效和安全性，包括基于《国际功能、残疾和健康分类》（ICF）核心集项目评估对生活质量（QoL）的影响。
40名18岁及以上（平均21.8岁）的CP患者参与了一项前瞻性、单中心、随机对照干预研究。所有参与者均被归类为粗大运动功能分类系统III级或更高，且均有先前研究中定义的明显流涎。一组（A组）接受100单位的BoNT-A治疗，另一组（B组）作为对照。在治疗组中，所有患者首先接受腮腺和下颌下腺联合注射，然后仅接受腮腺注射。主要结局变量为注射后流涎商数（DQ）降低50%或更多、总唾液流量降低30%或更多，以及通过一组与ICF中流涎相关的10个项目评估的生活质量。
A组中DQ至少降低50%的患者比例为45%，而B组为0.0%（P = 0.0012）；总唾液流量至少降低30%的患者比例，A组为90%，B组为10%（P < 0.0001）。在A组中，运动障碍型患者中有42.1%，痉挛型患者中有58.0%的DQ反应为降低50%或更好，这在统计学上无显著差异（P = 0.8045）。关于ICF问题，A组在几个相关项目上有统计学上的显著改善。仅进行腮腺注射的总体反应似乎没有显著差异。还回顾了其他相关性和不常见的不良反应经历。
在患有痉挛型或运动障碍型CP的患者中，注射A型肉毒毒素治疗流涎在唾液分泌的客观测量和与该病症相关的主观症状方面通常是有效的且总体安全。与仅注射腮腺相比，同时注射下颌下腺和腮腺似乎没有显著优势。
