Cendrowski Wojciech
Ogólnodostepna Przychodnia Specjalistyczna w Warszawie.
Neurol Neurochir Pol. 2004 Jul-Aug;38(4):299-306.
Placebo-controlled or open trials of immunomodulating drugs shed more light upon pivotal clinical issues in relapsing-remitting and secondary progressive multiple sclerosis (RR MS, SP MS). Extension over 4 years of IFN beta-1b, IFN beta-1a s.c. and glatiramer acetate trials provided modest clinical benefit in RR MS patients. After 4-8 years of treatment an annual relapse rate decreased (0.20-0.57) and proportion of progression free RR MS patients increased significantly (56-65%). The percentages of SP MS patients without relapses increased markedly in EUSPMS, IMPACT, NASMPS and SPECTRIMS trials to 36-63. However, the treatments did not slow progression in two latter clinical investigations (p=ns). In most non-responders to IFN beta the second-line immunomodulating drugs brought about clinical improvement. About half of MS patients showed one year or longer adherence to the first immunomodulating drug and nearly one fifth benefited from the change of this drug to another immunotherapeutic agent.
免疫调节药物的安慰剂对照试验或开放试验为复发缓解型和继发进展型多发性硬化症(RR MS,SP MS)的关键临床问题提供了更多线索。IFNβ-1b、皮下注射IFNβ-1a和醋酸格拉替雷试验超过4年的随访为RR MS患者带来了适度的临床益处。治疗4 - 8年后,年复发率下降(0.20 - 0.57),无进展RR MS患者的比例显著增加(56 - 65%)。在EUSPMS、IMPACT、NASMPS和SPECTRIMS试验中,无复发的SP MS患者百分比显著增加至36 - 63。然而,在后面两项临床研究中,这些治疗并未减缓疾病进展(p =无显著性差异)。在大多数对IFNβ无反应的患者中,二线免疫调节药物带来了临床改善。约一半的MS患者对第一种免疫调节药物有一年或更长时间的依从性,近五分之一的患者因将该药物更换为另一种免疫治疗药物而受益。