Partners Multiple Sclerosis Center, Brigham and Women's Hospital, 6th Floor, 1 Brookline Place, Brookline, MA 02445, USA.
Qual Life Res. 2012 Dec;21(10):1677-84. doi: 10.1007/s11136-011-0108-0. Epub 2012 Jan 12.
In this study, we estimate the impact of a recent relapse on physical and mental health in subjects with relapsing-remitting multiple sclerosis (RRMS) using validated patient-reported outcome (PRO) measures.
Subjects enrolled in the Comprehensive Longitudinal Investigation of MS at the Brigham and Women's Hospital with RRMS were eligible for enrollment. Subjects with a clinical visit within 45 days of a relapse were identified and divided into groups based on whether the relapse occurred before (recent relapse) (n = 59) or after the visit (pre-relapse) (n = 31). A group of subjects with no relapses was also identified (remission) (n = 336). PRO measures in these three groups were compared. All outcomes were compared using a t test and linear regression controlling for age, disease duration, sex, and EDSS.
Subjects with a recent relapse had significantly worse functioning on several physical and mental health scales compared to subjects in remission even after adjusting for potential confounders. Subjects with a recent relapse also showed significant deterioration on PRO measures over 1 year compared to subjects in remission (P < 0.05 for each comparison). Subjects in the pre-relapse group were not significantly different than subjects in remission.
Clinical relapses have a measurable effect on PRO in subjects with RRMS.
本研究采用经过验证的患者报告结局(PRO)测量方法,评估复发对复发缓解型多发性硬化症(RRMS)患者身心健康的影响。
在布莱根妇女医院进行全面纵向多发性硬化症研究的 RRMS 患者有资格入组。在复发后 45 天内有就诊记录的患者被识别出来,并根据复发是否发生在就诊前(近期复发)(n = 59)或就诊后(预复发)(n = 31)分为两组。还确定了一组无复发的患者(缓解)(n = 336)。对这三组的 PRO 测量结果进行了比较。所有结果均使用 t 检验和线性回归进行比较,控制了年龄、疾病持续时间、性别和 EDSS。
与缓解组相比,即使在调整了潜在混杂因素后,近期复发的患者在多项身体和心理健康量表上的功能明显更差。与缓解组相比,近期复发的患者在 PRO 测量上在 1 年内也显示出明显的恶化(每次比较 P < 0.05)。预复发组与缓解组之间无显著差异。
临床复发对 RRMS 患者的 PRO 有可衡量的影响。