Petracca Martina, Guidubaldi Arianna, Ricciardi Lucia, Ialongo Tàmara, Del Grande Alessandra, Mulas Delia, Di Stasio Enrico, Bentivoglio Anna Rita
Institute of Neurology, Università Cattolica del Sacro Cuore, Rome, Italy.
Institute of Neurology, Università Cattolica del Sacro Cuore, Rome, Italy.
Toxicon. 2015 Dec 1;107(Pt A):129-40. doi: 10.1016/j.toxicon.2015.08.014. Epub 2015 Aug 30.
In recent years, Botulinum Toxin has been shown to be efficacious and safe in the treatment of sialorrhea, but scanty data are available on its long term use. The aim of this study was to investigate adverse events, discriminate differences in safety, and evaluate the efficacy of long-term use of both abobotulinumtoxinA and rimabotulinumtoxinB ultrasound-guided injections for sialorrhea in a retrospective trial. Moreover we review the literature on this topic.
Consecutive patients with severe sialorrhea and receiving at least two ultrasound-guided intrasalivary glands abobotulinumtoxinA 250 U or rimabotulinumtoxinB 2500 U injections were included. Clinical and demographic data were collected. Safety and tolerability were assessed on the basis of patients' self-reports. Efficacy was assessed by recording the duration of benefit and by the Drooling Severity Scale and Drooling Frequency Scale 4 weeks after intervention. A review of literature was performed using 'Botulinum Toxin' and/or 'drooling' and/or 'sialorrhea' and/or 'hypersalivation' as keywords.
Sixty-five patients (32 Amyotrophic Lateral Sclerosis and 33 Parkinson's Disease) were treated in a total of 317 sessions (181 rimabotulinumtoxinB and 136 abobotulinumtoxinA). Both serotypes induced a clear-cut benefit in 89% of injections. Mean benefit duration was 87 days (range 30-240), similar for abobotulinumtoxinA and rimabotulinumtoxinB but significantly shorter in Amyotrophic Lateral Sclerosis group compared to Parkinson's Disease (p < 0.001). Older age was positively correlated to benefit duration (p = 0.003). Botulinum Toxin-related and injection-related side effects complicated respectively 8,2% and 1,5% of treatments. The only Botulinum Toxin-related adverse event was a change of saliva thickness, mostly rated mild to moderate and more frequent in Amyotrophic Lateral Sclerosis patients (p = NS).
Both 250 U abobotulinumtoxinA and 2500 U rimabotulinumtoxinB administered by ultrasound-guided intrasalivary gland injection are safe and effective in treating sialorrhea, even in long-term follow-up. Older age is significantly associated with longer benefit duration. Parkinson's Disease patients showed a more favorable safety-efficacy ratio than did Amyotrophic Lateral Sclerosis patients, due to lower adverse events (p = NS) and longer benefit duration (p < 0.001).
近年来，肉毒杆菌毒素已被证明在治疗流涎症方面有效且安全，但关于其长期使用的数据较少。本研究的目的是在一项回顾性试验中，调查不良事件，区分安全性差异，并评估长期使用a型肉毒杆菌毒素和b型肉毒杆菌毒素超声引导注射治疗流涎症的疗效。此外，我们回顾了关于该主题的文献。
纳入连续的重度流涎症患者，这些患者接受了至少两次超声引导下腮腺内注射250 U a型肉毒杆菌毒素或2500 U b型肉毒杆菌毒素。收集临床和人口统计学数据。根据患者的自我报告评估安全性和耐受性。在干预4周后，通过记录获益持续时间以及流口水严重程度量表和流口水频率量表来评估疗效。使用“肉毒杆菌毒素”和/或“流口水”和/或“流涎症”和/或“唾液分泌过多”作为关键词进行文献综述。
65例患者（32例肌萎缩侧索硬化症和33例帕金森病）共接受了317次治疗（181次b型肉毒杆菌毒素治疗和136次a型肉毒杆菌毒素治疗）。两种血清型在89%的注射中都产生了明显的获益。平均获益持续时间为87天（范围30 - 240天），a型肉毒杆菌毒素和b型肉毒杆菌毒素相似，但肌萎缩侧索硬化症组的获益持续时间明显短于帕金森病组（p < 0.001）。年龄较大与获益持续时间呈正相关（p = 0.003）。肉毒杆菌毒素相关和注射相关的副作用分别使8.2%和1.5%的治疗出现并发症。唯一与肉毒杆菌毒素相关的不良事件是唾液厚度改变，大多为轻度至中度，在肌萎缩侧索硬化症患者中更常见（p = 无显著差异）。
通过超声引导腮腺内注射给予250 U a型肉毒杆菌毒素和2500 U b型肉毒杆菌毒素在治疗流涎症方面都是安全有效的，即使在长期随访中也是如此。年龄较大与更长的获益持续时间显著相关。帕金森病患者的安全性 - 疗效比优于肌萎缩侧索硬化症患者，因为不良事件较少（p = 无显著差异）且获益持续时间更长（p < 0.001）。
