Koziol J A, Frutos A, Sipe J C, Romine J S, Beutler E
Department of Molecular and Experimental Medicine, Scripps Research Institute, La Jolla, CA 92037, USA.
J Neurol. 1996 Mar;243(3):209-13. doi: 10.1007/BF00868516.
We examined the degree of association between two neurologic impairment scales, the Extended Disability Status Scale (EDSS) and the Scripps Neurologic Rating Scale (SNRS), with data from a randomized, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of cladribine as treatment for chronic progressive multiple sclerosis (MS). We found that the EDSS and SNRS were not strongly correlated within individual patients, contrary to expectation; moreover, in 9 of the 48 evaluable patients, the directions of their changes from baseline values were not mutually consistent. The scales were differentially sensitive to clinical changes over time, with the EDSS indicating a more abrupt, and the SNRS a more gradual, change in the clinical course of disease. The validity of different impairment scales, and their sensitivity to detect clinical changes, should be formally assessed in future clinical trials using these scales as outcome measures.
我们利用一项随机、双盲、安慰剂对照临床试验的数据，该试验旨在评估克拉屈滨作为慢性进展性多发性硬化症（MS）治疗药物的安全性和有效性，研究了两种神经功能损害量表——扩展残疾状态量表（EDSS）和斯克里普斯神经评定量表（SNRS）之间的关联程度。我们发现，与预期相反，EDSS和SNRS在个体患者中并非高度相关；此外，在48例可评估患者中的9例，其相对于基线值的变化方向并不一致。这些量表对随时间推移的临床变化的敏感性不同，EDSS表明疾病临床进程变化更为突然，而SNRS则表明变化更为渐进。在未来使用这些量表作为结局指标的临床试验中，应正式评估不同损害量表的有效性及其检测临床变化的敏感性。
