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本文引用的文献

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Identifying an important change estimate for the Multiple Sclerosis Walking Scale-12 (MSWS-12v1) for interpreting clinical trial results.确定用于解释临床试验结果的多发性硬化步行量表12（MSWS - 12v1）的重要变化估计值。
Mult Scler J Exp Transl Clin. 2015 Aug 5;1:2055217315596993. doi: 10.1177/2055217315596993. eCollection 2015 Jan-Dec.
2
Monitoring long-term efficacy of fampridine in gait-impaired patients with multiple sclerosis.监测司来吉兰对改善多发性硬化症患者步态障碍的长期疗效。
Neurology. 2017 Feb 28;88(9):832-841. doi: 10.1212/WNL.0000000000003656. Epub 2017 Feb 1.
3
Subjective and objective assessment of physical activity in multiple sclerosis and their relation to health-related quality of life.多发性硬化症患者身体活动的主观和客观评估及其与健康相关生活质量的关系。
BMC Neurol. 2017 Jan 13;17(1):10. doi: 10.1186/s12883-016-0783-0.
4
Effects of Dalfampridine Extended-release Tablets on 6-minute Walk Distance in Patients With Multiple Sclerosis: A Post Hoc Analysis of a Double-blind, Placebo-controlled Trial.达氟吡啶缓释片对多发性硬化症患者6分钟步行距离的影响：一项双盲、安慰剂对照试验的事后分析
Clin Ther. 2015 Dec 1;37(12):2780-7. doi: 10.1016/j.clinthera.2015.10.014. Epub 2015 Nov 10.
5
Walking function in clinical monitoring of multiple sclerosis by telemedicine.通过远程医疗对多发性硬化症进行临床监测时的行走功能
J Neurol. 2015 Jul;262(7):1706-13. doi: 10.1007/s00415-015-7764-x. Epub 2015 May 10.
6
The clinical meaning of walking speed as measured by the timed 25-foot walk in patients with multiple sclerosis.多发性硬化症患者 25 英尺定时行走测试所测行走速度的临床意义。
JAMA Neurol. 2014 Nov;71(11):1386-93. doi: 10.1001/jamaneurol.2014.1895.
7
Estimating a minimal clinically important difference for the EuroQol 5-Dimension health status index in persons with multiple sclerosis.估算多发性硬化症患者的欧洲五维健康量表健康状况指数的最小临床重要差异。
Health Qual Life Outcomes. 2014 May 5;12:66. doi: 10.1186/1477-7525-12-66.
8
Evaluating walking in patients with multiple sclerosis: which assessment tools are useful in clinical practice?评估多发性硬化症患者的步行能力：哪些评估工具在临床实践中有用？
Int J MS Care. 2011 Spring;13(1):4-14. doi: 10.7224/1537-2073-13.1.4.
9
Assessing the long-term clinical benefit of prolonged-release fampridine tablets in a real-world setting: a review of 67 cases.评估缓释氨吡啶片在实际临床环境中的长期临床益处：67例病例回顾
Patient Relat Outcome Meas. 2013 Oct 23;4:75-85. doi: 10.2147/PROM.S42957. eCollection 2013.
10
Clinically meaningful performance benchmarks in MS: timed 25-foot walk and the real world.MS 中的临床有意义的绩效基准：定时 25 英尺行走和现实世界。
Neurology. 2013 Nov 19;81(21):1856-63. doi: 10.1212/01.wnl.0000436065.97642.d2. Epub 2013 Oct 30.

联合步行结果测量可识别对缓释氨吡啶有临床意义的反应。

Combined walking outcome measures identify clinically meaningful response to prolonged-release fampridine.

作者信息

Sola-Valls Núria, Blanco Yolanda, Sepúlveda María, Llufriu Sara, Martínez-Lapiscina Elena H, Zubizarreta Irati, Pulido-Valdeolivas Irene, Montejo Carmen, Villoslada Pablo, Saiz Albert

机构信息

Service of Neurology, Hospital Clinic, University of Barcelona, Spain Neuroimmunology Program, Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), Barcelona, Spain.

出版信息

Ther Adv Neurol Disord. 2018 Jun 10;11:1756286418780007. doi: 10.1177/1756286418780007. eCollection 2018.

DOI:10.1177/1756286418780007
PMID:29977342
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6024337/
Abstract

BACKGROUND

Gait impairment is common in multiple sclerosis (MS) and negatively impacts patients' health-related quality of life (HRQoL). Prolonged-release fampridine (PR-fam) improves walking speed, but it is unclear which walking measures are the most suitable for identifying treatment response. Our aim was to assess the effect of PR-fam and the outcome measures that best identify short- and long-term clinically meaningful response.

METHODS

We conducted a prospective study in 32 MS patients treated with PR-fam for a year. The assessments at 2 weeks, 3, 6 and 12 months included: timed 25-foot walk (T25FW), 6-minute walk test (6MWT), MS Walking Scale-12 (MSWS-12), a five-level version of the EuroQoL-5 dimensions, and accelerometry. PR-fam response was defined as an improvement in T25FW ⩾20%.

RESULTS

Twenty-five (78%) patients were considered responders after 2 weeks of PR-fam and improved significantly in all measures. Responders to T25FW and MSWS-12 ( = 19) showed a significant improvement in HRQoL and accelerometer data compared with responders only to T25FW ( = 6). At 1 year, 15/20 (75%) patients remained responders, but only those with permanent response to T25FW and MSWS-12 ( = 8; 53%) showed a significant improvement in 6MWT and HRQoL.

CONCLUSION

The combination of T25FW and MSWS-12 identify better those patients with a clinically significant benefit of PR-fam.

摘要

背景

步态障碍在多发性硬化症（MS）中很常见，对患者的健康相关生活质量（HRQoL）产生负面影响。缓释氨吡啶（PR- fam）可提高步行速度，但尚不清楚哪种步行测量方法最适合确定治疗反应。我们的目的是评估PR- fam的效果以及最能确定短期和长期临床意义反应的结局指标。

方法

我们对32例接受PR- fam治疗一年的MS患者进行了一项前瞻性研究。在2周、3个月、6个月和12个月时的评估包括：25英尺计时步行（T25FW）、6分钟步行试验（6MWT）、MS步行量表-12（MSWS-12）、欧洲五维度健康量表的五级版本以及加速度计测量。PR- fam反应定义为T25FW改善≥20%。

结果

25例（78%）患者在接受PR- fam治疗2周后被视为有反应者，所有测量指标均有显著改善。T25FW和MSWS-12的反应者（n = 19）与仅T25FW的反应者（n = 6）相比，HRQoL和加速度计数据有显著改善。在1年时，15/20例（75%）患者仍为反应者，但只有那些对T25FW和MSWS-12有持续反应的患者（n = 8；53%）在6MWT和HRQoL方面有显著改善。

结论

T25FW和MSWS-12的组合能更好地识别那些从PR- fam治疗中获得临床显著益处的患者。