口服沙丁胺醇能否改善多发性硬化症患者的疲劳？一项安慰剂对照的初步研究。

Does oral salbutamol improve fatigue in multiple sclerosis? A pilot placebo-controlled study.

作者信息

de Almeida Gustavo M, Scola Rosana H, Ducci Renata D P, Cirino Raphael H D, Cláudia S K Kay, Lorenzoni Paulo J, Lima Pedro H S, de Oliveira Lívia P, Werneck Lineu C

机构信息

Demyelinating and Neuromuscular Disorders Service, Neurology Division, Internal Medicine Department, Hospital de Clínicas, Universidade Federal do Paraná (UFPR), General Carneiro Street 181, Curitiba, PR 80060-900, Brazil.

出版信息

Mult Scler Relat Disord. 2020 Nov;46:102586. doi: 10.1016/j.msard.2020.102586. Epub 2020 Oct 16.

DOI:10.1016/j.msard.2020.102586

PMID:33296982

Abstract

BACKGROUND

Because MS-related fatigue could be associated with enhanced proinflammatory cytokine production, drugs with immunomodulatories properties, such as salbutamol, may represent an alternative treatment. We aimed to evaluate the effect of salbutamol on MS-related fatigue.

METHODS

Thirty patients with relapsing-remitting MS who were between 18 and 69 years old, and suffering from fatigue, were evaluated with the Fatigue Severity Scale (FSS) and the Brazilian version of the neurological fatigue index for multiple sclerosis (NFI/MS-BR). They received salbutamol 2 mg twice a day or a placebo in a pilot randomized, double-masked placebo-controlled trial. The primary outcome was the change in the FSS score at the end of 90 days. The secondary outcome was the efficacy, represented by changes in their scores on the NFI/MS-BR subdomains (in the same period) and the Expanded Disability Status Scale (EDSS) at the end of 90 days.

RESULTS

Thirty subjects were allocated to receive either salbutamol (14) or a placebo (16). There was no superiority of salbutamol over the placebo in the FSS outcome at 30 (p ==0.498), 60 (p = 0.854) and 90 (p = 0.240) days. There was no a significant decrease in the proportion of patients with severe or moderate fatigue in the salbutamol group at the end of the follow-up. The scores on the NFI/MS-BR and its subscales did not improve significantly with treatment. No significant difference was observed in the EDSS outcome (p = 0.313). No serious adverse events were found. An increase in heart rate was evident in the salbutamol group only in the first 30 days, but without statistical significance in relation to placebo (p = 0.077).

CONCLUSION

Treatment with salbutamol does not improve fatigue in patients with relapsing-remitting MS.

摘要

背景

由于与多发性硬化症（MS）相关的疲劳可能与促炎细胞因子生成增加有关，具有免疫调节特性的药物，如沙丁胺醇，可能是一种替代治疗方法。我们旨在评估沙丁胺醇对与MS相关的疲劳的影响。

方法

在一项初步随机、双盲、安慰剂对照试验中，对30例年龄在18至69岁之间且患有疲劳的复发缓解型MS患者，使用疲劳严重程度量表（FSS）和巴西版的多发性硬化症神经疲劳指数（NFI/MS-BR）进行评估。他们每天两次接受2毫克沙丁胺醇或安慰剂治疗。主要结局是90天结束时FSS评分的变化。次要结局是疗效，以90天结束时NFI/MS-BR子域（同期）和扩展残疾状态量表（EDSS）评分的变化表示。

结果

30名受试者被分配接受沙丁胺醇（14名）或安慰剂（16名）治疗。在第30天（p = 0.498）、60天（p = 0.854）和90天（p = 0.240）时，沙丁胺醇在FSS结局方面并不优于安慰剂。随访结束时，沙丁胺醇组中重度或中度疲劳患者的比例没有显著下降。治疗后NFI/MS-BR及其子量表的评分没有显著改善。在EDSS结局方面未观察到显著差异（p = 0.313）。未发现严重不良事件。仅在最初30天内，沙丁胺醇组心率明显增加，但与安慰剂相比无统计学意义（p = 0.077）。