Texas Children's Hospital, Baylor College of Medicine, Houston, TX 77030 , USA.
Expert Opin Pharmacother. 2011 Nov;12(16):2573-81. doi: 10.1517/14656566.2011.622268. Epub 2011 Oct 4.
Epilepsy affects approximately 3 million people in the USA and up to 2% of the worldwide population. The yearly direct medical cost of epilepsy in the USA alone is estimated to be $9.5 billion. Epilepsy affects both children and adults and can significantly impair quality of life. Zonisamide is a second-generation antiepileptic drug (AED) that has broad-spectrum efficacy, a favorable side-effect profile and simpler dosing than earlier drugs.
The history of the development of zonisamide is reviewed in this paper. The data available demonstrating zonisamide's mechanism of action as a voltage-gated sodium channel inhibitor, a T-type calcium channel inhibitor, an enhancer of GABA release and an inhibitor of glutamate release are also reviewed. Four key Phase III clinical trials are reviewed in detail, as are subsequent postmarketing trials that have expanded the therapeutic indication for zonisamide.
From the available clinical data, zonisamide is a viable first-line and adjunctive therapeutic for partial-onset epilepsy and should be considered as an adjunctive therapeutic for a wide-range of generalized epilepsies.
癫痫影响了美国约 300 万人和全球多达 2%的人口。仅在美国，癫痫的年直接医疗费用估计就达 95 亿美元。癫痫影响儿童和成人，并可显著降低生活质量。佐尼沙胺是第二代抗癫痫药（AED），与早期药物相比，它具有广谱疗效、良好的副作用特征和更简单的剂量方案。
本文回顾了佐尼沙胺的发展历史。还回顾了可用数据，证明佐尼沙胺作为电压门控钠离子通道抑制剂、T 型钙通道抑制剂、GABA 释放增强剂和谷氨酸释放抑制剂的作用机制。详细回顾了四项关键的 III 期临床试验，以及随后扩大佐尼沙胺治疗适应证的上市后试验。
从现有临床数据来看，佐尼沙胺是部分发作性癫痫的可行一线和辅助治疗药物，也应被视为广泛的全面性癫痫的辅助治疗药物。
