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美国食品和药物管理局批准的肉毒毒素治疗肌张力障碍的共识指南。

FDA Approvals and Consensus Guidelines for Botulinum Toxins in the Treatment of Dystonia.

机构信息

Movement Disorders and Neuromodulation Center, Department of Neurology, University of California, San Francisco, CA 94115, USA.

出版信息

Toxins (Basel). 2020 May 17;12(5):332. doi: 10.3390/toxins12050332.

DOI:10.3390/toxins12050332
PMID:32429600
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7290737/
Abstract

In 2016, the American Academy of Neurology (AAN) published practice guidelines for botulinum toxin (BoNT) in the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. This article, focusing on dystonia, provides context for these guidelines through literature review. Studies that led to Food and Drug Administration (FDA) approval of each toxin for dystonia indications are reviewed, in addition to several studies highlighted by the AAN guidelines. The AAN guidelines for the use of BoNT in dystonia are compared with those of the European Federation of the Neurological Societies (EFNS), and common off-label uses for BoNT in dystonia are discussed. Toxins not currently FDA-approved for the treatment of dystonia are additionally reviewed. In the future, additional toxins may become FDA-approved for the treatment of dystonia given expanding research in this area.

摘要

2016 年,美国神经病学学会(AAN)发布了肉毒毒素(BoNT)治疗眼睑痉挛、颈肌张力障碍、成人痉挛和头痛的治疗指南。本文通过文献回顾,为这些指南提供了 dystonia 的背景知识。对导致每种毒素获得 FDA 批准用于治疗肌张力障碍的适应症的研究进行了回顾,此外还回顾了 AAN 指南中强调的几项研究。对 AAN 指南中 BoNT 在 dystonia 中的使用与欧洲神经病学学会联合会(EFNS)的指南进行了比较,并讨论了 dystonia 中 BoNT 的常见超适应证使用。还额外审查了目前未获 FDA 批准用于治疗 dystonia 的毒素。鉴于该领域的研究不断扩展,未来可能会有更多的毒素获得 FDA 批准用于治疗 dystonia。

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本文引用的文献

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Am J Clin Dermatol. 2020 Apr;21(2):157-162. doi: 10.1007/s40257-019-00482-2.
2
Safety and pharmacodynamics of a novel recombinant botulinum toxin E (rBoNT-E): Results of a phase 1 study in healthy male subjects compared with abobotulinumtoxinA (Dysport®).新型重组肉毒毒素 E(rBoNT-E)的安全性和药效学:与 abobotulinumtoxinA(Dysport®)相比,在健康男性受试者中进行的 1 期研究结果。
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Comparison of Safety and Efficacy of Botox and Neuronox in the Management of Benign Essential Blepharospasm: A Split-face Study.肉毒杆菌毒素和Neuronox治疗良性原发性眼睑痉挛的安全性和有效性比较:一项半脸研究。
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J Neural Transm (Vienna). 2019 Feb;126(2):141-148. doi: 10.1007/s00702-018-1960-7. Epub 2019 Jan 2.
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