Bykova O V, Nankina I A, Drozdova I M, Kvasova O V, Batysheva T T, Boiko A N
Pirogov Russian National Research Medical University, Moscow.
Pirogov Russian National Research Medical University, Moscow; Pirogov Russian National Research Medical University, Moscow.
Zh Nevrol Psikhiatr Im S S Korsakova. 2016;116(2 Pt 2):44-53. doi: 10.17116/jnevro20161162244-53.
The vast majority of therapies are being evaluated and introduced for the treatment of adult multiple sclerosis (MS). A role of these drugs in the management of pediatric MS has yet to be defined both in Russia and in the whole world. Despite the fact that today the study of new drugs in the pediatric population have included in routine practices of the big pharmaceutical agencies, such as FDA and EMA, recommendations for the treatment of pediatric patients with MS are based not so much on a long period of systematic clinical research, but on professional consensus of international expert associations, in particular, the International pediatric multiple sclerosis study group (IPMSSG). The clinical trials include the small number of patients which is not comparable to those conducted in adults. Therefore, there is a need for study designs for assessment of efficacy and safety of the drugs for MS treatment in children and adolescents. The authors present the IPMSSG concept on the treatment of pediatric MS taking into account peculiarities of the Russian legislation and experience of national experts.
绝大多数疗法正在被评估并引入用于治疗成人多发性硬化症(MS)。在俄罗斯乃至全世界,这些药物在儿童MS治疗中的作用尚未明确。尽管如今大型制药机构(如美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA))已将儿科人群新药研究纳入常规操作,但针对儿童MS患者的治疗建议并非基于长期系统的临床研究,而是基于国际专家协会,特别是国际儿童多发性硬化症研究组(IPMSSG)的专业共识。临床试验纳入的患者数量较少,与成人临床试验不可比。因此,需要针对评估儿童和青少年MS治疗药物疗效和安全性的研究设计。作者结合俄罗斯立法特点和本国专家经验,介绍了IPMSSG关于儿童MS治疗的理念。