氨己烯酸：药物特性的全面综述，包括最近 FDA 批准后的临床新进展。
Vigabatrin: a comprehensive review of drug properties including clinical updates following recent FDA approval.
机构信息
Creighton University School of Pharmacy and Health Professions, Omaha, NE 68178, USA.
出版信息
Expert Opin Pharmacother. 2009 Dec;10(18):3077-89. doi: 10.1517/14656560903451690.
BACKGROUND
Vigabatrin (Sabril) was approved in the USA in mid-2009 for the adjunctive treatment of refractory complex partial seizures and as treatment of infantile spasms. Vigabatrin's more than 30-year history of research and development is condensed into a clinically relevant review pertaining to this 2009 approval.
METHODS/DISCUSSION: A review of the scientific literature was conducted with special focus given to the drug molecule, its mechanism of action, its effects on living systems (e.g., pharmacokinetic, pharmacologic and toxicologic), and its anticipated role among antiepileptic drugs in the USA.
CONCLUSIONS
The recent approval of vigabatrin makes a significant addition to antiepileptic drug options. The FDA implemented a Risk Evaluation and Mitigation Strategy to control for the possibility of severe adverse drug events.
背景
氨己烯酸（Sabril）于 2009 年年中在美国获得批准，作为辅助治疗耐药性复杂部分性癫痫发作以及婴儿痉挛症的治疗药物。氨己烯酸历经 30 多年的研究和开发，在 2009 年获得批准，相关的临床研究成果被浓缩为一篇综述。
方法/讨论：对科学文献进行了综述，特别关注药物分子、作用机制、对活体系统的影响（如药代动力学、药理学和毒理学），以及在美国抗癫痫药物中的预期作用。
结论
氨己烯酸的最近批准为抗癫痫药物的选择提供了一个重要的补充。FDA 实施了风险评估和缓解策略，以控制严重药物不良事件的可能性。
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