Miller D M, Cohen J A, Kooijmans M, Tsao E, Cutter G, Baier M
Mellen Center for Multiple Sclerosis Treatment and Research, Department of Neurology, Cleveland Clinic Foundation, OH 44195, USA.
Mult Scler. 2006 Apr;12(2):180-6. doi: 10.1191/135248506ms1270oa.
The IMPACT study demonstrated the benefit of interferon beta-1a (IFNbeta-1a, Avonex) two-year change in disability measured by the Multiple Sclerosis Functional Composite (MSFC) in secondary progressive multiple sclerosis (SP-MS) and health-related quality of life (HRQoL) measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI). The IMPACT data permit a detailed assessment of the relation between clinical and self-reported measures.
IMPACT was an international randomized, double-blind, placebo-controlled trial of SP-MS patients. As the MSQLI is only in English, this report includes US and Canadian subjects. Subjects were randomized to weekly intramuscular (im) injections of INbeta-1a (60 microg) or placebo for 24 months.
At baseline and follow-up, MSQLI correlations were generally stronger with the EDSS than with the MSQLI, MSFC but comparable with MSFC components. Combining the two groups, MSQLI changes for those in the best and worst MSFC change quartiles demonstrated a statistical difference for six of the 11 MSQLI scales. Linear regression demonstrated that EDSS change from baseline to month-24 scores was correlated with change in two MSQLI components.
These data support the appropriateness of using the MSQLI with individuals who have SP-MS.
IMPACT研究证明了干扰素β-1a（IFNβ-1a，阿沃尼）在继发进展型多发性硬化（SP-MS）中通过多发性硬化功能综合评分（MSFC）测量的残疾两年变化以及在通过多发性硬化生活质量量表（MSQLI）测量的健康相关生活质量（HRQoL）方面的益处。IMPACT数据允许对临床测量和自我报告测量之间的关系进行详细评估。
IMPACT是一项针对SP-MS患者的国际随机、双盲、安慰剂对照试验。由于MSQLI只有英文版本，本报告纳入了美国和加拿大的受试者。受试者被随机分为每周一次肌肉注射INβ-1a（60微克）或安慰剂组，为期24个月。
在基线和随访时，MSQLI与扩展残疾状态量表（EDSS）的相关性总体上强于与MSQLI、MSFC的相关性，但与MSFC各组分的相关性相当。将两组合并后，在MSFC变化最好和最差的四分位数中，MSQLI在11个MSQLI量表中的6个量表上的变化显示出统计学差异。线性回归表明，从基线到第24个月的EDSS变化分数与两个MSQLI组分的变化相关。
这些数据支持将MSQLI用于SP-MS患者的适用性。
