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在多发性硬化症的 Alemtuzumab 治疗的头 2 年中,客观评估生理、身体和认知功能以及患者报告的结果:一项前瞻性观察研究。

Objectively assessed physiological, physical, and cognitive function along with patient-reported outcomes during the first 2 years of Alemtuzumab treatment in multiple sclerosis: a prospective observational study.

机构信息

Exercise Biology, Department of Public Health, Aarhus University, Dalgas Avenue 4, Aarhus, Denmark.

The Danish MS Hospitals, Ry and Haslev, Denmark.

出版信息

J Neurol. 2022 Sep;269(9):4895-4908. doi: 10.1007/s00415-022-11134-7. Epub 2022 Apr 28.

Abstract

INTRODUCTION

In persons with multiple sclerosis (pwMS), little evidence exist on the effects of Alemtuzumab on physiological, physical, and cognitive function along with patient-reported outcomes, despite these domains are being rated as highly important. Therefore, our purpose was to perform a prospective observational study to examine these outlined outcomes during the first two years of Alemtuzumab treatment in pwMS.

METHODS

In n = 17 relapsing-remitting pwMS, physiological function [body composition; bone mineral content; muscle strength; aerobic capacity], physical function [6-min walk test (6MWT, primary outcome); timed 25 ft walk test (T25FWT); six spot step test (SSST); 9-step stair ascend (9SSA); timed up and go test (TUG); 5 × sit to stand test (5STS)], cognitive function [selective reminding test (SRT); symbol digit modalities test (SDMT)], and patient-reported outcomes [multiple sclerosis impact scale-29 (MSIS29); 12-item multiple sclerosis walking scale (MSWS12); modified fatigue impact scale (MFIS); hospital anxiety and depression scale (HADS)] were assessed prior to Alemtuzumab treatment initiation as well as 3, 6, 12, and 24 months into the treatment.

RESULTS

Improvements were observed at 24-month follow-up in T25FWT (+ 8%), SSST (+ 10%), SDMT (+ 5.2 points, 53% improved more than the clinical cut-off score) and SRT, whereas the primary outcome 6MWT, and all other remaining outcomes, remained stable throughout the Alemtuzumab treatment period.

CONCLUSION

The present findings suggest that Alemtuzumab treatment in relapsing-remitting pwMS can improve certain domains of physical function (short distance walking) and cognitive function (processing speed, memory), and furthermore stabilize physiological and physical function along with patient-reported outcomes.

TRIAL REGISTRATION

Registered at clinicaltrials.gov: NCT03806387.

摘要

简介

在多发性硬化症患者(pwMS)中,尽管这些领域被认为非常重要,但关于 Alemtuzumab 对生理、身体和认知功能以及患者报告的结果的影响的证据很少。因此,我们的目的是进行一项前瞻性观察研究,在 pwMS 接受 Alemtuzumab 治疗的头两年内检查这些概述的结果。

方法

在 17 名复发缓解型 pwMS 中,生理功能[身体成分;骨矿物质含量;肌肉力量;有氧能力]、身体功能[6 分钟步行测试(6MWT,主要结果);定时 25 英尺步行测试(T25FWT);六步台阶测试(SSST);9 步楼梯上升(9SSA);计时起立行走测试(TUG);5 次坐立站起测试(5STS)]、认知功能[选择性提醒测试(SRT);符号数字模态测试(SDMT)]和患者报告的结果[多发性硬化症影响量表-29(MSIS29);12 项多发性硬化症步行量表(MSWS12);改良疲劳影响量表(MFIS);医院焦虑和抑郁量表(HADS)]在 Alemtuzumab 治疗开始前以及治疗 3、6、12 和 24 个月时进行评估。

结果

在 24 个月的随访中,T25FWT(+8%)、SSST(+10%)、SDMT(+5.2 分,53%的人改善超过临床截止分数)和 SRT 得到改善,而主要结果 6MWT 和所有其他剩余结果在 Alemtuzumab 治疗期间保持稳定。

结论

目前的研究结果表明,Alemtuzumab 治疗复发缓解型 pwMS 可以改善某些身体功能(短距离行走)和认知功能(处理速度、记忆力)领域,此外还可以稳定生理和身体功能以及患者报告的结果。

试验注册

在 clinicaltrials.gov 上注册:NCT03806387。

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