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多发性硬化症患者在接受那他珠单抗输注两周后疲劳、抑郁及处理速度的改善:标准给药方案与延长间隔给药方案之间无差异

Improvement of fatigue, depression, and processing speed two weeks post Natalizumab infusion in Multiple Sclerosis: No difference between standard and extended interval dosing schedules.

作者信息

Leodori Giorgio, Mancuso Marco, Maccarrone Davide, Tartaglia Matteo, Ianniello Antonio, Baione Viola, Ferrazzano Gina, Malimpensa Leonardo, Belvisi Daniele, Berardelli Alfredo, Pozzilli Carlo, Conte Antonella

机构信息

IRCCS Neuromedicine, Pozzilli, IS 86077, Italy; Department of Human Neurosciences, Sapienza University of Rome, Rome 00185, Italy.

Department of Human Neurosciences, Sapienza University of Rome, Rome 00185, Italy.

出版信息

Mult Scler Relat Disord. 2024 Dec;92:106146. doi: 10.1016/j.msard.2024.106146. Epub 2024 Oct 31.

DOI:10.1016/j.msard.2024.106146
PMID:39504729
Abstract

BACKGROUND

Fatigue, depression and slow processing speed are debilitating symptoms in people with Relapsing-Remitting Multiple Sclerosis (RRMS) that significantly impacts on the quality of life. Natalizumab, a disease-modifying treatment, improves clinical symptoms but questions remain about the comparative efficacy between its standard interval dosing (SID) and extended interval dosing (EID) schedules.

OBJECTIVE

To examine the impact of short term natalizumab dosing schedules-SID versus EID-on the so called "invisible symptoms", specifically focusing on symptom exacerbation during the 'wearing-off' phase before infusion and the subsequent relief post-infusion.

METHODS

Forty-two RRMS patients were assessed one week before (T0) and two weeks after pre-and post-natalizumab infusion (T1) for fatigue symptoms using the Fatigue Scale for Motor and Cognitive Functions (FSMC), the Modified Fatigue Impact Scale (MFIS), and the Fatigue Symptoms and Impacts Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS). Processing speed and depression were measured by the symbol digit modality test (SDMT), and the Beck Depression Inventory-II (BDI-II). Participants were categorized into either the SID or EID dosing schedules of natalizumab, and their outcomes were compared.

RESULTS

Forty-two patients (21 SID; 21 EID) completed the study. Fatigue severity scales, SDMT, and BDI-II scores improved from T0 to T1. No significant differences in fatigue symptoms were found between the SID and EID groups, whether during the "wearing-off" period (T0) or post-infusion (T1).

CONCLUSIONS

Both SID and EID dosing regimens of natalizumab are similarly effective in reducing fatigue symptoms, depression and improving processing speed in individuals with RRMS, with no observed differences during the "wearing-off" periods or after re-infusion.

摘要

背景

疲劳、抑郁和处理速度减慢是复发缓解型多发性硬化症(RRMS)患者的衰弱症状,对生活质量有显著影响。那他珠单抗作为一种疾病修正治疗药物,可改善临床症状,但关于其标准间隔给药(SID)和延长间隔给药(EID)方案之间的相对疗效仍存在疑问。

目的

研究那他珠单抗短期给药方案——SID与EID——对所谓“隐形症状”的影响,特别关注输液前“药效消退”阶段的症状加重情况以及输液后的缓解情况。

方法

42例RRMS患者在那他珠单抗输注前一周(T0)和输注后两周(T1),使用运动和认知功能疲劳量表(FSMC)、改良疲劳影响量表(MFIS)以及复发型多发性硬化症疲劳症状与影响问卷(FSIQ-RMS)评估疲劳症状。通过符号数字模态测试(SDMT)和贝克抑郁量表第二版(BDI-II)测量处理速度和抑郁情况。参与者被分为那他珠单抗的SID或EID给药方案组,并比较他们的结果。

结果

42例患者(21例SID;21例EID)完成了研究。从T0到T1,疲劳严重程度量表、SDMT和BDI-II评分均有所改善。在SID组和EID组之间,无论是在“药效消退”期(T0)还是输液后(T1),疲劳症状均未发现显著差异。

结论

那他珠单抗的SID和EID给药方案在减轻RRMS患者的疲劳症状、抑郁以及提高处理速度方面同样有效,在“药效消退”期或再次输液后均未观察到差异。

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