Spirin N N, Kasatkin D S, Stepanov I O, Shipova E G, Baranova N S
Zh Nevrol Psikhiatr Im S S Korsakova. 2012;112(8):27-33.
Authors have followed up 230 patients with multiple sclerosis treated with disease modifying drugs (DMD) using the data of the Multiple sclerosis register of the Yaroslavl oblast during 2009-2011. Original drugs and their generics registered in Russia are used. Patients received interferon-beta 1a for intramuscular introduction (avonex - 3.0%), interferon-beta 1a for hypodermic injection (rebif - 19.2%, genfakson - 8.5%), interferon-beta 1b (betaferon - 16.5%, extavia - 18.2%, ronbetal - 18.0%), glatimer acetate (copaxone - 16.7%). Adverse effects were recorded and subjective tolerability of the drug by the patient was assessed. Statistically significant differences in the safety profile between some bioanalogues and original DMD were identified. This finding suggests that effects of different DMD should be studied in depth in clinical and post marketing trials.
作者利用雅罗斯拉夫尔州多发性硬化症登记处2009 - 2011年的数据，对230例接受疾病修正药物（DMD）治疗的多发性硬化症患者进行了随访。使用的是在俄罗斯注册的原研药物及其仿制药。患者接受用于肌肉注射的干扰素β-1a（阿沃尼克斯 - 3.0%）、用于皮下注射的干扰素β-1a（利比 - 19.2%，捷扶康 - 8.5%）、干扰素β-1b（倍泰龙 - 16.5%，雅美罗 - 18.2%，罗奈特 - 18.0%）、醋酸格拉替雷（考帕松 - 16.7%）。记录不良反应并评估患者对药物的主观耐受性。确定了一些生物仿制药与原研DMD在安全性方面的统计学显著差异。这一发现表明，应在临床和上市后试验中深入研究不同DMD的效果。
