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乙酰左旋肉碱与金刚烷胺治疗多发性硬化症疲劳效果的比较:一项试点随机双盲交叉试验的结果

Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial.

作者信息

Tomassini Valentina, Pozzilli Carlo, Onesti Emanuela, Pasqualetti Patrizio, Marinelli Fabiana, Pisani Angela, Fieschi Cesare

机构信息

Department of Neurological Sciences, University of Rome "La Sapienza", viale dell' Università 30, Rome 00185, Italy.

出版信息

J Neurol Sci. 2004 Mar 15;218(1-2):103-8. doi: 10.1016/j.jns.2003.11.005.

Abstract

Treatment with acetyl L-carnitine (ALCAR) has been shown to improve fatigue in patients with chronic fatigue syndrome, but there have been no trials on the effect of ALCAR for treating fatigue in multiple sclerosis (MS). To compare the efficacy of ALCAR with that of amantadine, one of the drugs most widely used to treat MS-related fatigue, 36 MS patients presenting fatigue were enrolled in a randomised, double-blind, crossover study. Patients were treated for 3 months with either amantadine (100 mg twice daily) or ALCAR (1 g twice daily). After a 3-month washout period, they crossed over to the alternative treatment for 3 months. Patients were rated at baseline and every 3 months according to the Fatigue Severity Scale (FSS), the primary endpoint of the study. Secondary outcome variables were: Fatigue Impact Scale (FIS), Beck Depression Inventory (BDI) and Social Experience Checklist (SEC). Six patients withdrew from the study because of adverse reactions (five on amantadine and one on ALCAR). Statistical analysis showed significant effects of ALCAR compared with amantadine for the Fatigue Severity Scale (p = 0.039). There were no significant effects for any of the secondary outcome variables. The results of this study show that ALCAR is better tolerated and more effective than amantadine for the treatment of MS-related fatigue.

摘要

已证明用乙酰左旋肉碱(ALCAR)治疗可改善慢性疲劳综合征患者的疲劳症状,但尚无关于ALCAR治疗多发性硬化症(MS)相关疲劳效果的试验。为比较ALCAR与金刚烷胺(治疗MS相关疲劳最广泛使用的药物之一)的疗效,36名出现疲劳症状的MS患者被纳入一项随机、双盲、交叉研究。患者分别接受3个月的金刚烷胺(每日两次,每次100毫克)或ALCAR(每日两次,每次1克)治疗。经过3个月的洗脱期后,他们交叉接受另一种治疗3个月。根据疲劳严重程度量表(FSS,该研究的主要终点)在基线时和每3个月对患者进行评分。次要结局变量包括:疲劳影响量表(FIS)、贝克抑郁量表(BDI)和社会经历清单(SEC)。6名患者因不良反应退出研究(5名使用金刚烷胺,1名使用ALCAR)。统计分析表明,与金刚烷胺相比,ALCAR在疲劳严重程度量表方面有显著效果(p = 0.039)。对任何次要结局变量均无显著影响。本研究结果表明,在治疗MS相关疲劳方面,ALCAR比金刚烷胺耐受性更好且更有效。

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