The MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO 63131, USA.
Expert Rev Neurother. 2013 Jun;13(6):589-602. doi: 10.1586/ern.13.52.
Fingolimod 0.5 mg (Gilenya(™), Novartis Pharmaceuticals Corporation, FL, USA) is the first once-daily oral therapy approved for relapsing forms of multiple sclerosis (MS) in the USA and for rapidly evolving severe MS or highly active disease despite IFN-β treatment in Europe. An extensive clinical development program has established fingolimod as an effective therapy that reduces relapses by approximately half compared with placebo or intramuscular IFN-β1a. Over 2 years of postmarketing experience in >63,000 MS patients (with >73,000 patient-years of exposure) across the world has contributed to a well-characterized safety profile for fingolimod, and its side effects are manageable through patient monitoring. This article discusses the unique mechanisms of action of fingolimod in the immune and nervous systems, the key data underlying its efficacy and safety profile and perspectives on the role of fingolimod in current and future treatment strategies for MS.
氟轻松 0.5 毫克（Gilenya（™），诺华制药公司，佛罗里达州，美国）是第一种在美国批准用于治疗复发型多发性硬化症（MS）的每日一次口服疗法，在欧洲也被批准用于快速进展性严重 MS 或高度活跃性疾病，尽管已经进行了 IFN-β 治疗。广泛的临床开发计划已经证实，与安慰剂或肌肉内 IFN-β1a 相比，氟轻松可有效减少约一半的复发。在全球范围内，超过 63000 名 MS 患者（超过 73000 名患者年的暴露）进行了超过 2 年的上市后经验，为氟轻松的安全性特征提供了充分的描述，其副作用可以通过患者监测进行管理。本文讨论了氟轻松在免疫系统和神经系统中的独特作用机制、支持其疗效和安全性特征的关键数据，以及氟轻松在当前和未来 MS 治疗策略中的作用。
