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一项关于接受β-1a干扰素治疗的多发性硬化症患者生活质量和副作用的纵向研究。

A longitudinal study of quality of life and side effects in patients with multiple sclerosis treated with interferon beta-1a.

作者信息

Zivadinov Robert, Zorzon Marino, Tommasi Maria Antonietta, Nasuelli Davide, Bernardi Monica, Monti-Bragadin Luisa, Cazzato Giuseppe

机构信息

Department of Clinical Medicine and Neurology, Cattinara Hospital, University of Trieste, Strada di Fiume, 447-34149, Trieste, Italy.

出版信息

J Neurol Sci. 2003 Dec 15;216(1):113-8. doi: 10.1016/s0022-510x(03)00225-9.

Abstract

In a 12-month follow-up study, we evaluated 27 patients (18 F and 9 M) with relapsing-remitting (RR) multiple sclerosis (MS), who had started treatment with interferon beta-1a (IFNbeta-1a) (Avonex), 30 microg i.m. once weekly, 6-18 months (median 10 months) before study entry. Quality of life (QOL), disability, independence, cognitive performances, symptoms of depression and anxiety, and fatigue were assessed at baseline, 6 months and 12 months. The frequency and severity of the side effects of treatment, at hours 0-12, 13-48 and 49-168 after the injection, were self-reported weekly in a structured questionnaire. QOL did not change significantly during the follow-up. The percentage of patients who reported side effects after the injection of IFNbeta-1a remained constant during the 52 weeks. The mean number of side effects increased significantly from the 6th to the 12th month. The general linear model analysis of variance disclosed significant changes over time for almost all side effects, but we did not find any correlation between QOL and number of side effects. In conclusion, 1-year treatment with IFNbeta-1a did not significantly change patient's QOL. Disability progression correlated with patient's QOL. Side effects, which were mild, did not diminish over time, did not induce treatment discontinuation and did not interfere with QOL.

摘要

在一项为期12个月的随访研究中,我们评估了27例复发缓解型(RR)多发性硬化症(MS)患者(18例女性和9例男性),这些患者在研究入组前6 - 18个月(中位时间为10个月)开始使用β-1a干扰素(IFNβ-1a)(阿沃尼克斯)治疗,剂量为30μg,每周一次肌肉注射。在基线、6个月和12个月时评估生活质量(QOL)、残疾程度、独立性、认知表现、抑郁和焦虑症状以及疲劳情况。通过结构化问卷让患者每周自行报告注射后0 - 12小时、13 - 48小时和49 - 168小时治疗副作用的频率和严重程度。随访期间QOL没有显著变化。在52周内,报告注射IFNβ-1a后出现副作用的患者百分比保持不变。副作用的平均数量从第6个月到第12个月显著增加。一般线性模型方差分析显示几乎所有副作用随时间都有显著变化,但我们未发现QOL与副作用数量之间存在任何相关性。总之,IFNβ-1a治疗1年并未显著改变患者的QOL。残疾进展与患者的QOL相关。副作用较轻,未随时间减轻,未导致治疗中断,也未干扰QOL。

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