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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.

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。

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