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复发缓解型多发性硬化症的复发缓解:CombiRx 数据集分析。

Relapse recovery in relapsing-remitting multiple sclerosis: An analysis of the CombiRx dataset.

机构信息

Departments of Clinical Neurosciences and Community Health Sciences, University of Calgary, Calgary, AB, Canada.

Department of Neurology, Hospital Sant Joan Despí Moisès Broggi, Barcelona, Spain.

出版信息

Mult Scler. 2023 Dec;29(14):1776-1785. doi: 10.1177/13524585231202320. Epub 2023 Oct 13.

Abstract

BACKGROUND

Clinical relapses are the defining feature of relapsing forms of multiple sclerosis (MS), but relatively little is known about the time course of relapse recovery.

OBJECTIVE

The aim of this study was to investigate the time course of and patient factors associated with the speed and success of relapse recovery in people with relapsing-remitting MS (RRMS).

METHODS

Using data from CombiRx, a large RRMS trial (clinicaltrials.gov identifier NCT00211887), we measured the time to recovery from the first on-trial relapse. We used Kaplan-Meier survival analyses and Cox regression models to investigate the association of patient factors with the time to unconfirmed and confirmed relapse recovery.

RESULTS

CombiRx included 1008 participants. We investigated 240 relapses. Median time to relapse recovery was 111 days. Most recovery events took place within 1 year of relapse onset: 202 of 240 (84%) individuals recovered during follow-up, 161 of 202 (80%) by 180 days, and 189 of 202 (94%) by 365 days. Relapse severity was the only factor associated with relapse recovery.

CONCLUSION

Recovery from relapses takes place up to approximately 1 year after the event. Relapse severity, but no other patient factors, was associated with the speed of relapse recovery. Our findings inform clinical practice and trial design in RRMS.

摘要

背景

临床复发是多发性硬化症(MS)复发型的主要特征,但对于复发恢复的时间过程相对知之甚少。

目的

本研究旨在探讨复发缓解型多发性硬化症(RRMS)患者复发恢复的速度和与患者相关的因素及其与复发恢复时间的关系。

方法

利用 CombiRx 这一大规模 RRMS 试验(clinicaltrials.gov 标识符 NCT00211887)的数据,我们测量了从第一次试验性复发中恢复的时间。我们使用 Kaplan-Meier 生存分析和 Cox 回归模型来研究患者因素与未确认和确认的复发恢复时间之间的关联。

结果

CombiRx 纳入了 1008 名参与者。我们研究了 240 次复发。复发恢复的中位时间为 111 天。大多数恢复事件发生在复发发作后 1 年内:240 次复发中有 202 次(84%)在随访期间恢复,202 次中有 161 次(80%)在 180 天内恢复,202 次中有 189 次(94%)在 365 天内恢复。复发严重程度是唯一与复发恢复相关的因素。

结论

复发的恢复发生在事件发生后约 1 年。复发严重程度,但没有其他患者因素,与复发恢复的速度相关。我们的研究结果为 RRMS 的临床实践和试验设计提供了信息。

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