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皮下注射干扰素β-1a 对复发缓解型多发性硬化轻度残疾患者的认知功能有积极影响:来自 COGIMUS 研究的 2 年结果。

Subcutaneous Interferon Beta-1a Has a Positive Effect on Cognitive Performance in Mildly Disabled Patients with Relapsing-Remitting Multiple Sclerosis: 2-Year Results from the COGIMUS Study.

机构信息

Multiple Sclerosis Centre Sicilia Region, First Neurology Clinic, University Hospital Catania, Via Santa Sofia 78, 95123 Catania, Italy

出版信息

Ther Adv Neurol Disord. 2009 Mar;2(2):67-77. doi: 10.1177/1756285608101379.

Abstract

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.

摘要

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。

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Cognitive impairment in multiple sclerosis.多发性硬化症中的认知障碍。
J Neurol. 2007 May;254 Suppl 2:II35-42. doi: 10.1007/s00415-007-2010-9.

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