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复发缓解型多发性硬化症免疫调节疗法的比较评估

Comparative assessment of immunomodulating therapies for relapsing-remitting multiple sclerosis.

作者信息

Khan Omar, Zabad Rana, Caon Christina, Zvartau-Hind Marina, Tselis Alexandros, Lisak Robert

机构信息

Department of Neurology, Multiple Sclerosis Center, Wayne State University School of Medicine, *D-University Health Center, 4201 St. Antoine, Detroit, MI 48201, USA.

出版信息

CNS Drugs. 2002;16(8):563-78. doi: 10.2165/00023210-200216080-00005.

Abstract

The past decade has seen unprecedented advances in the development of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS), a disease that has a worldwide prevalence of two million patients. Four agents with the ability to modulate the immune system are now being widely used for RRMS. Of these, three are forms of interferon (IFN)-beta [IFNbeta-1b and two preparations of IFNbeta-1a (Avonex and Rebif], and one is a polypeptide of four amino acids (glatiramer acetate) with a unique mechanism of action. The administration regimens for the IFNbeta-1a products differ, with Avonex being given as 30 microg intramuscularly once a week and Rebif being given as 22 or 44 microg subcutaneously three times a week. It appears safe to predict that both forms of IFNbeta and glatiramer acetate will remain standard treatments for MS for years to come. However, with four therapeutic options available for RRMS, selecting a single therapy is often difficult and necessitates comparisons of the agents, which can be contentious. All four agents have shown superiority over placebo in pivotal phase III trials. Three recent prospective comparative studies have indicated that IFNbeta-1b, Rebif and glatiramer acetate may be more optimal choices than Avonex for patients with RRMS. In a pharmaceutical environment with an estimated worldwide market of $US2.5 billion annually for RRMS, comparative studies are understandably provocative, but at the same time provide meaningful information to clinicians and patients.

摘要

在过去十年中,复发缓解型多发性硬化症(RRMS)的疾病修饰疗法取得了前所未有的进展,这种疾病在全球范围内有两百万患者。目前,有四种能够调节免疫系统的药物被广泛用于RRMS。其中,三种是干扰素(IFN)-β的不同形式[IFNβ-1b以及两种IFNβ-1a制剂(阿沃尼单抗和利比)],另一种是具有独特作用机制的四氨基酸多肽(醋酸格拉替雷)。IFNβ-1a产品的给药方案有所不同,阿沃尼单抗为每周一次30微克肌肉注射,利比为每周三次22或44微克皮下注射。可以有把握地预测,在未来几年中,这两种形式的IFNβ和醋酸格拉替雷都将仍然是MS的标准治疗方法。然而,对于RRMS有四种治疗选择,选择单一疗法往往很困难,需要对这些药物进行比较,而这可能存在争议。在关键的III期试验中,所有这四种药物都显示出优于安慰剂。最近的三项前瞻性比较研究表明,对于RRMS患者,IFNβ-1b、利比和醋酸格拉替雷可能比阿沃尼单抗是更优选择。在一个RRMS全球年市场估计为25亿美元的制药环境中,比较研究引发争议是可以理解的,但同时也为临床医生和患者提供了有意义的信息。

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