多发性硬化治疗药物非临床药效学评价

Nonclinical efficacy of multiple sclerosis modify drugs

多发性硬化(MS)是一种累及中枢神经系统的获得性自身免疫性疾病,是青壮年神经性致残的常见原因。近20年来,免疫修正治疗在MS治疗中取得最瞩目的进步,从1993年的干扰素β至今,美国FDA已批准了14种MS治疗药物上市,本文简要回顾和总结了已上市MS治疗药物的作用机制和不良反应,重点阐述非临床药效学内容和考虑要点,为新药研发和评价提供参考。

Multiple sclerosis(MS)is an acquired demyelinating disease of the central nervous system.It is the common cause of disability in adults.The most significant progress in the treatment of MS in the last two decades has been the development of immunomodulatory therapies.Since the introduction of first immunomodulating medication,interferon beta-1b in 1993,there are 14 medications approved by US FDA for treatment of MS.The mechanism of action and side-effect profile of different MS Drugs are briefly described.The objective of the present review is to set out the considerations of nonclinical efficacy testing to provide the resource for medicinal products development.