Stone L A, Frank J A, Albert P S, Bash C N, Calabresi P A, Maloni H, McFarland H F
Department of Neurology, Mayo Clinic Scottsdale, AZ, USA.
Neurology. 1997 Sep;49(3):862-9. doi: 10.1212/wnl.49.3.862.
MRI is a valuable tool to examine the pathophysiology and natural history of multiple sclerosis (MS), and several large multicenter trials have utilized MRI as a secondary outcome measures. We previously examined the effect of interferon beta-1b on contrast-enhancing lesions on MRI using a baseline versus treatment design, and found that on treatment there is a reduction in mean frequency of enhancing lesions over the group. Using an expanded number of patients and the same trial design, we examined the individual response to treatment more extensively. We find that the effect seen previously is still present, and that there is heterogeneity in the amount of decrease in contrast-enhancing lesions. This expanded number of patients and trial design allows for the discussion of new criteria for individual response to treatment, which are applied in the current trial. These approaches may be useful in the examination, early testing, and comparison of experimental therapeutic agents in MS as well as in the characterization of patients who do or do not have a response seen on MRI.
磁共振成像(MRI)是检查多发性硬化症(MS)病理生理学和自然病史的重要工具,多项大型多中心试验已将MRI用作次要结局指标。我们之前采用基线与治疗设计,研究了β-1b干扰素对MRI上对比增强病灶的影响,发现治疗后全组增强病灶的平均频率有所降低。我们使用更多患者并采用相同的试验设计,更广泛地研究了个体对治疗的反应。我们发现之前观察到的效果仍然存在,并且对比增强病灶减少的程度存在异质性。更多患者和试验设计使得我们能够讨论个体对治疗反应的新标准,这些标准已应用于当前试验。这些方法可能有助于对MS实验性治疗药物进行检查、早期测试和比较,以及对MRI上有或无反应的患者进行特征描述。