Ziemssen Tjalf, Hoffman Josef, Apfel Rainer, Kern Simone
MS Center, Neurological University Clinic, Technical University of Dresden, Dresden, Germany.
Health Qual Life Outcomes. 2008 Sep 5;6:67. doi: 10.1186/1477-7525-6-67.
Treatment of multiple sclerosis patients with glatiramer acetate has been demonstrated a beneficial effect on disease activity. The objective of this prospective naturalistic study was to evaluate the impact of glatiramer acetate on fatigue and work absenteeism.
291 treatment-naïve patients with relapsing remitting multiple sclerosis were included and treated with glatiramer acetate for twelve months. Relapse rates, disability, fatigue symptoms, days of absence from work and adverse events were monitored. Fatigue was measured with the MFIS scale and with a visual analogue scale.
Total MFIS scores decreased by 7.6 +/- 16.4 from 34.6 to 27.0 (p < or = 0.001). Significant reductions were observed on all three subscales of the MFIS. Fatigue symptoms, assessed using a visual analogue scale, decreased by 1.04 +/- 2.88 cm from 4.47 cm to 3.43 cm (p < or = 0.001). The proportion of patients absent from work at least once was reduced by a factor of two from 65.1% to 30.1% (p < or = 0.001). Tolerance to treatment was rated as very good or good in 78.3% of patients. Adverse effects, most frequently local injection site reactions, were reported in 15.1% of patients.
Treatment with glatiramer acetate was associated with a significant improvement in fatigue symptoms and a marked reduction in absence from work. Treatment was well-tolerated. Such benefits are of relevance to overall patient well-being.
已证实醋酸格拉替雷治疗多发性硬化症患者对疾病活动有有益影响。这项前瞻性自然主义研究的目的是评估醋酸格拉替雷对疲劳和工作缺勤的影响。
纳入291例初治复发缓解型多发性硬化症患者,用醋酸格拉替雷治疗12个月。监测复发率、残疾情况、疲劳症状、缺勤天数和不良事件。用MFIS量表和视觉模拟量表测量疲劳。
MFIS总分从34.6降至27.0,下降了7.6±16.4(p≤0.001)。在MFIS的所有三个子量表上均观察到显著下降。使用视觉模拟量表评估的疲劳症状从4.47厘米降至3.43厘米,下降了1.04±2.88厘米(p≤0.001)。至少缺勤一次的患者比例从65.1%降至30.1%,降低了一半(p≤0.001)。78.3%的患者对治疗的耐受性被评为非常好或良好。15.1%的患者报告有不良反应,最常见的是局部注射部位反应。
醋酸格拉替雷治疗与疲劳症状的显著改善和缺勤的显著减少相关。治疗耐受性良好。这些益处与患者的整体健康状况相关。