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富马酸二甲酯用于复发缓解型多发性硬化症:理论依据、作用机制、药代动力学、疗效及安全性

Dimethyl fumarate in relapsing-remitting multiple sclerosis: rationale, mechanisms of action, pharmacokinetics, efficacy and safety.

作者信息

Dubey Duvyanshu, Kieseier Bernd C, Hartung Hans P, Hemmer Bernhard, Warnke Clemens, Menge Til, Miller-Little William A, Stuve Olaf

机构信息

UT Southwestern, Dallas, TX, USA.

出版信息

Expert Rev Neurother. 2015 Apr;15(4):339-46. doi: 10.1586/14737175.2015.1025755.

DOI:10.1586/14737175.2015.1025755
PMID:25800129
Abstract

Dimethyl fumarate (DMF), a fumaric acid ester, is a new orally available disease-modifying agent that was recently approved by the US FDA and the EMA for the management of relapsing forms of multiple sclerosis (MS). Fumaric acid has been used for the management of psoriasis, for more than 50 years. Because of the known anti-inflammatory properties of fumaric acid ester, DMF was brought into clinical development in MS. More recently, neuroprotective and myelin-protective mechanism actions have been proposed, making it a possible candidate for MS treatment. Two Phase III clinical trials (DEFINE, CONFIRM) have evaluated the safety and efficacy of DMF in patients with relapsing-remitting MS. Being an orally available agent with a favorable safety profile, it has become one of the most commonly prescribed disease-modifying agents in the USA and Europe.

摘要

富马酸二甲酯(DMF)是一种富马酸酯,是一种新型口服可用的疾病改善药物,最近被美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)批准用于治疗复发型多发性硬化症(MS)。富马酸已用于治疗银屑病超过50年。由于富马酸酯具有已知的抗炎特性,DMF被引入MS的临床开发。最近,有人提出了神经保护和髓鞘保护机制作用,使其成为MS治疗的可能候选药物。两项III期临床试验(DEFINE、CONFIRM)评估了DMF在复发缓解型MS患者中的安全性和有效性。作为一种口服可用且安全性良好的药物,它已成为美国和欧洲最常用的疾病改善药物之一。

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