Allegheny General Hospital, Pittsburgh, Pa., USA.
Neuroepidemiology. 2015;44(1):16-23. doi: 10.1159/000369621. Epub 2015 Jan 23.
The Expanded Disability Status Scale (EDSS), based on different functional system scores (FSS), remains the most frequently used disability assessment in relapsing-remitting multiple sclerosis (RRMS). In this analysis, we evaluated the relationship between sustained disability progression, measured by EDSS, and simultaneous changes in individual FSS domains.
A post hoc analysis was performed on data from placebo-treated RRMS patients from four large, randomized, multicenter, phase 3 clinical trials. Sustained disability progression was defined as a ≥1.0-point EDSS score increase over a ≥3- or ≥6-month period. Simultaneous sustained disability progression and worsening of individual FSS domains was analyzed.
The majority of patients experienced sustained disability progression and simultaneous worsening of ≥1 FSS domain, with ≥1-point worsening in the pyramidal domain being most frequently associated with sustained disability progression (in 31-51% of patients), followed by ≥1-point worsening in the cerebellar (35-41% of patients) and sensory (31-45% of patients) domains.
The key FSS components correlating with sustained disability progression, measured by EDSS, appear to be pyramidal, cerebellar, and sensory. In this analysis, the simultaneous worsening of consistent FSS domains confirms the validity and reliability of the use of sustained EDSS progression as a measure of disability progression.
扩展残疾状况量表（EDSS）基于不同的功能系统评分（FSS），仍然是最常用于复发缓解型多发性硬化症（RRMS）的残疾评估方法。在这项分析中，我们评估了 EDSS 测量的持续性残疾进展与个体 FSS 域同时变化之间的关系。
对来自四项大型、随机、多中心、3 期临床试验的安慰剂治疗 RRMS 患者的数据进行了事后分析。持续性残疾进展定义为 EDSS 评分在≥3 个月或≥6 个月期间增加≥1.0 分。分析了同时发生的持续性残疾进展和个体 FSS 域的恶化。
大多数患者经历了持续性残疾进展和≥1 个 FSS 域的同时恶化，其中以锥体域≥1 点恶化与持续性残疾进展最相关（在 31%-51%的患者中），其次是小脑域≥1 点恶化（在 35%-41%的患者中）和感觉域≥1 点恶化（在 31%-45%的患者中）。
与 EDSS 测量的持续性残疾进展相关的关键 FSS 成分似乎是锥体、小脑和感觉。在这项分析中，一致的 FSS 域的同时恶化证实了使用持续 EDSS 进展作为残疾进展衡量标准的有效性和可靠性。
