Multiple Sclerosis Centre Sicilia Region, First Neurology Clinic, University Hospital Catania, Via Santa Sofia 78, 95123 Catania, Italy
Ther Adv Neurol Disord. 2009 Mar;2(2):67-77. doi: 10.1177/1756285608101379.
The effect of interferon (IFN) beta-1a (44 and 22 μg subcutaneously [sc] three times weekly [tiw]) on cognition in mildly disabled patients with relapsing-remitting multiple sclerosis (McDonald criteria; Expanded Disability Status Scale =4.0) was assessed by validated neuropsychological testing at baseline and at regular intervals for up to 2 years in this ongoing open-label, 3-year study. Year-2 data were available for 356 patients (22 μg, n = 175; 44μg, n = 181). The proportion of patients with impaired cognitive function was stable during the study: 21.4% at baseline and 21.6% at 2 years. At 2 years, the proportion of patients with =3 impaired cognitive tests was significantly lower in the 44 μg treatment group (17.0%) compared with the 22 μg group (26.5%; p = 0.034), although there was already a trend towards a higher proportion of patients with cognitive impairment in the 22 μg group at baseline. Factors associated with impairment in = three cognitive tests after 2 years were age (odds ratio [OR]: 1.05; 95% confidence interval [CI]: 1.00-1.09), verbal intelligence quotient (OR: 0.95; 95% CI: 0.92-0.98), and having = three impaired cognitive tests at baseline (OR: 11.60; 95% CI: 5.94-22.64). These interim results show that IFN beta-1a sc tiw may have beneficial effects on cognitive function as early as 2 years after treatment initiation, but the final 3-year data of the study are required to confirm these results.
在这项正在进行的、为期 3 年的开放性标签研究中,用经过验证的神经心理学测试,在基线和至多 2 年的定期时间点评估干扰素(IFN)β-1a(44 和 22μg 皮下[sc]每周 3 次[tiw])对复发缓解型多发性硬化症(McDonald 标准;扩展残疾状况量表[EDSS] =4.0)轻度残疾患者认知功能的影响。2 年的数据可用于 356 例患者(22μg,n = 175;44μg,n = 181)。研究期间,认知功能障碍患者的比例保持稳定:基线时为 21.4%,2 年时为 21.6%。2 年后,44μg 治疗组认知测试受损的患者比例(17.0%)显著低于 22μg 组(26.5%;p = 0.034),尽管基线时 22μg 组已有认知障碍患者比例较高的趋势。2 年后认知测试受损 = 3 项的患者相关因素包括年龄(比值比[OR]:1.05;95%置信区间[CI]:1.00-1.09)、言语智商(OR:0.95;95%CI:0.92-0.98)和基线时认知测试受损 = 3 项(OR:11.60;95%CI:5.94-22.64)。这些中期结果表明,IFNβ-1a sc tiw 在治疗开始后 2 年内可能对认知功能有有益影响,但需要该研究的最终 3 年数据来证实这些结果。