高剂量肉毒毒素治疗：安全性、疗效获益和持久性。
High-dose Botulinum Toxin Therapy: Safety, Benefit, and Endurance of Efficacy.
机构信息
Department of Neurology, Fixel Institute for Neurological Diseases, University of Florida, Gainesville, FL, USA.
出版信息
Tremor Other Hyperkinet Mov (N Y). 2020 Feb 27;10. doi: 10.7916/tohm.v0.749. eCollection 2020.
BACKGROUND
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.
METHODS
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.
RESULTS
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.
DISCUSSION
The majority of patients tolerated >400 U OnaA with continued benefit. OnaA doses >400 U may be safe and effective in appropriate patients.
背景
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。
方法
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。
结果
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。
讨论
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。
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