Institute of Regional Health Research, University of Southern Denmark, J.B. Winsløws Vej 19.3, 5000 Odense C, Denmark; and MS-clinic of Southern Jutland (Sønderborg, Vejle, Esbjerg), Sønderborg Hospital, Denmark
Odense University Hospital, Denmark.
Mult Scler. 2014 Dec;20(14):1872-80. doi: 10.1177/1352458514533844. Epub 2014 May 22.
We aimed to evaluate the effect of slow-release (SR) Fampridine on multiple outcome measures reflecting different domains, and to compare the responsiveness of the Six Spot Step Test (SSST) and the Timed 25 Foot Walk (T25FW).
For this study 108 participants were included. On day 0 they were tested with the T25FW, the SSST, the 9-Hole Peg Test (9-HPT), the 5 Times Sit-To-Stand test (5-STS) and the Symbol Digit Modalities Test (SDMT). Four weeks of treatment with SR Fampridine 10 mg BID was commenced. Participants were tested again after 26-28 days of treatment.
Mean changes observed were: SSST -3.4±6.4 s (p<0.001), T25FW -1.2±3.7 s (p<0.001), 9-HPT -1.2±6.0 s (p<0.001), 5- STS -3.4±7.2 s (p<0.001) and SDMT 1.4±4.8 a.u. (p=0.003). Change on the SSST differed significantly from T25FW (SSST 17.0±19.6% vs. T25FW 11.2±17.1%, p=0.0013). Some 48.6% were found to have a meaningful change on the SSST compared with 25.7% on the T25FW. The response to treatment with SR Fampridine did not correlate with age, sex, Expanded Disability Status Scale and disease duration.
SR Fampridine treatment has significant effects on different domains including upper and lower body and cognition. Furthermore, the SSST is more responsive to the effect of SR Fampridine than is the T25FW. ClinicalTrials.gov identifier: NCT01656148.
我们旨在评估缓释(SR)苯丙胺对反映不同领域的多种结局指标的影响,并比较 6 点台阶测试(SSST)和定时 25 英尺步行(T25FW)的反应性。
本研究纳入了 108 名参与者。在第 0 天,他们接受了 T25FW、SSST、9 孔钉测试(9-HPT)、5 次坐立测试(5-STS)和符号数字模态测试(SDMT)的测试。开始接受 SR 苯丙胺 10mg BID 治疗 4 周。治疗后 26-28 天再次进行测试。
观察到的平均变化为:SSST-3.4±6.4 s(p<0.001),T25FW-1.2±3.7 s(p<0.001),9-HPT-1.2±6.0 s(p<0.001),5-STS-3.4±7.2 s(p<0.001)和 SDMT 1.4±4.8 a.u.(p=0.003)。SSST 的变化与 T25FW 显著不同(SSST 17.0±19.6% vs. T25FW 11.2±17.1%,p=0.0013)。与 T25FW 相比,有 48.6%的患者 SSST 有明显变化,而 T25FW 为 25.7%。SR 苯丙胺治疗的反应与年龄、性别、扩展残疾状况量表和疾病持续时间无关。
SR 苯丙胺治疗对包括上下肢体和认知在内的不同领域具有显著影响。此外,SSST 对 SR 苯丙胺的反应比 T25FW 更敏感。临床试验注册号:NCT01656148。