关键词: FDA blepharospasm botulinum toxin cervical dystonia dystonia

Mesh : Acetylcholine Release Inhibitors / adverse effects therapeutic use Botulinum Toxins / adverse effects therapeutic use Consensus Drug Approval Drug Compounding Dystonia / drug therapy Humans Off-Label Use Practice Guidelines as Topic / standards United States United States Food and Drug Administration / standards

来  源:   DOI:10.3390/toxins12050332   PDF(Sci-hub)   PDF(Pubmed)

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,美国神经病学会(AAN)发布了肉毒杆菌毒素(BoNT)治疗眼睑痉挛的实践指南,宫颈肌张力障碍,成人痉挛,和头痛。这篇文章,专注于肌张力障碍,通过文献综述为这些指南提供了背景。审查了导致食品和药物管理局(FDA)批准每种毒素用于肌张力障碍适应症的研究,除了AAN指南强调的几项研究。将在肌张力障碍中使用BoNT的AAN指南与欧洲神经学会联合会(EFNS)的指南进行了比较,并讨论了BoNT在肌张力障碍中的常见标签外用途。另外审查了目前未被FDA批准用于治疗肌张力障碍的毒素。在未来,鉴于该领域的研究不断扩大,其他毒素可能已获得FDA批准用于治疗肌张力障碍。
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