Department of Neurology, Fixel Institute for Neurological Diseases, University of Florida, Gainesville, FL, USA.
Tremor Other Hyperkinet Mov (N Y). 2020 Feb 27;10. doi: 10.7916/tohm.v0.749. eCollection 2020.
Botulinum neurotoxin therapy (BoNT) is a powerful tool for treating many neurologic disorders. The U.S. Food and Drug Administration (FDA)-approved maximum onabotulinum toxin A (OnaA) dose is 400 units (U) per visit, but higher doses are commonly necessary, particularly when treating multiple body regions.
We collected demographics, OnaA dose, body regions injected and indications, patient-reported efficacy via 7-point Clinical Global Impression Scale (CGIS), and duration of benefit.
Sixty-eight patients were identified receiving OnaA >400 U/session. Dystonia (n = 44) and spasticity (n = 24) were the most common indications for high-dose OnaA. Mean duration of benefit was 9 weeks (standard deviation [SD] 3). More than 70% of patients self-reported "very much improved" or "much improved" at 6 month, 1 year, and last visit. No serious adverse effects were reported.
The majority of patients tolerated >400 U OnaA with continued benefit. OnaA doses >400 U may be safe and effective in appropriate patients.
肉毒毒素神经阻滞疗法（BoNT）是治疗许多神经疾病的有力工具。美国食品和药物管理局（FDA）批准的最大剂量的肉毒毒素 A（OnaA）为每次 400 单位（U），但通常需要更高的剂量，特别是在治疗多个身体部位时。
我们收集了患者的人口统计学资料、OnaA 剂量、注射的身体部位和适应证、患者通过 7 点临床总体印象量表（CGIS）报告的疗效以及获益持续时间。
共确定了 68 名接受 OnaA 剂量>400 U/次的患者。高剂量 OnaA 最常用于治疗肌张力障碍（n=44）和痉挛（n=24）。获益的平均持续时间为 9 周（标准差[SD]为 3）。超过 70%的患者在 6 个月、1 年和最后一次就诊时自我报告“非常好”或“好得多”。未报告严重不良事件。
大多数患者耐受>400 U OnaA 且持续获益。在适当的患者中，OnaA 剂量>400 U 可能是安全有效的。
