与转变为继发进展型多发性硬化症相关的患者报告结局
Patient-reported outcomes associated with transition to secondary progressive multiple sclerosis.
作者信息
Healy Brian C, Zurawski Jonathan, Chitnis Tanuja, Weiner Howard L, Glanz Bonnie I
机构信息
Partners MS Center, Brigham and Women's Hospital, Boston, MA, USA.
Department of Neurology, Harvard Medical School, Boston, MA, USA.
出版信息
Qual Life Res. 2022 Jun;31(6):1799-1805. doi: 10.1007/s11136-021-03034-6. Epub 2021 Nov 16.
PURPOSE
To investigate patient-reported outcome (PRO) measures in patients with relapsing-remitting multiple sclerosis (RRMS) who transition to secondary progressive multiple sclerosis (SPMS).
METHODS
Subjects enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at Brigham and Women's Hospital (CLIMB) who completed PRO measures in the RRMS and SPMS phases were identified (n = 52). The PRO measures were Medical Outcomes Study Short-Form 36 Health Survey (SF-36), the Modified Fatigue Impact Scale (MFIS), and the Center for Epidemiologic Studies Depression Scale (CESD). Two control groups of RRMS CLIMB patients who did not progress to SPMS were identified based on different matching criteria related to age, sex, disease duration and Expanded Disability Status Scale (EDSS). Summary statistics for each PRO were calculated at the last RRMS measurement and first SPMS measurement, and the change over this transition was calculated using a paired t-test. Patients who transitioned were compared to the control groups using linear regression to adjust for age, disease duration and EDSS and a mixed model to further account for the matching with a random effect for matched group.
RESULTS
Patients who transitioned from RRMS to SPMS had noticeable deficits in terms of Quality of Life (QOL) and fatigue at the visit prior to the transition. Patients worsened in terms of SF-36 Role Physical (- 3.6 [- 6.6, - 0.7]), Social Functioning (- 3.7 [- 6.4, - 1.0]), and Physical Component Summary (- 2.3 [- 4.5, - 0.1]) during the transition from RRMS to SPMS. When patients who transitioned were compared to the matched subjects, they had worse scores on several outcomes, including Physical Functioning (adjusted mean difference = - 10.8 [- 14.1, - 7.5]), Physical Component Summary (- 5.2 [- 9.3, - 1.0]), fatigue (8.9 [1.7, 16.1]), and depression (3.1 [0.3, 5.9]).
CONCLUSIONS
Patients in the period closely preceding transition from RRMS to SPMS have worse physical QOL and fatigue compared to subjects who remain RRMS.
目的
调查复发缓解型多发性硬化症（RRMS）向继发进展型多发性硬化症（SPMS）转变的患者的患者报告结局（PRO）指标。
方法
确定了在布莱根妇女医院参加多发性硬化症综合纵向研究（CLIMB）的受试者，他们在RRMS和SPMS阶段完成了PRO指标（n = 52）。PRO指标包括医学结局研究简明健康调查（SF-36）、改良疲劳影响量表（MFIS）和流行病学研究中心抑郁量表（CESD）。根据与年龄、性别、病程和扩展残疾状态量表（EDSS）相关的不同匹配标准，确定了两组未进展为SPMS的RRMS CLIMB患者作为对照组。在RRMS的最后一次测量和SPMS的第一次测量时计算每个PRO的汇总统计数据，并使用配对t检验计算这一转变过程中的变化。使用线性回归对转变的患者与对照组进行比较，以调整年龄、病程和EDSS，并使用混合模型进一步考虑与匹配组的随机效应进行匹配。
结果
从RRMS转变为SPMS的患者在转变前的就诊时，在生活质量（QOL）和疲劳方面存在明显缺陷。在从RRMS转变为SPMS的过程中，患者在SF-36身体角色（-3.6 [-6.6, -0.7]）、社会功能（-3.7 [-6.4, -1.0]）和身体成分汇总得分（-2.3 [-4.5, -0.1]）方面有所恶化。当将转变的患者与匹配的受试者进行比较时，他们在几个结局方面得分更差，包括身体功能（调整后平均差异=-10.8 [-14.1, -7.5]）、身体成分汇总得分（-5.2 [-9.3, -1.0]）、疲劳（8.9 [1.7, 16.1]）和抑郁（3.1 [0.3, 5.9]）。
结论
与仍处于RRMS阶段的受试者相比，在从RRMS转变为SPMS之前的这段时间里，患者的身体QOL和疲劳状况更差。
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