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复发缓解型多发性硬化症患者中无疾病活动-3(NEDA-3)状态:来自主要接受干扰素治疗的沙特队列的证据。

No evidence of disease activity-3 (NEDA-3) status in patients with relapsing remitting multiple sclerosis: Evidence from Saudi cohort receiving mainly Interferon.

机构信息

Department of Neurology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam. King Fahd University Hospital, Khobar, 31952, Kingdom of Saudi Arabia.

出版信息

Mult Scler Relat Disord. 2021 Jun;51:102875. doi: 10.1016/j.msard.2021.102875. Epub 2021 Mar 2.

DOI:10.1016/j.msard.2021.102875
PMID:33691260
Abstract

BACKGROUND

No evidence of disease activity (NEDA) is a composite surrogate assessing the responsiveness to various disease-modifying treatments (DMTs) in patients with relapsing and remitting multiple sclerosis (RRMS), addressing clinical as well as radiological disease activity. Despite the rising prevalence of multiple sclerosis in Saudi Arabia (SA), there is a lack of evidence focusing on this important aspect in the management of RRMS. This study aimed to identify the prevalence of NEDA-3 status achievement in patients with RRMS on DMTs (mainly the interferon) and to describe the factors affecting its attainment.

METHOD

This was a retrospective, cross-sectional study carried out at King Fahd University Hospital after obtaining institutional ethical approval. The electronic records of 119 patients diagnosed with RRMS were reviewed. Clinical manifestations at initial presentation, relapse after starting treatment, disability progression, and development of new lesions on follow-up magnetic resonance imaging were all documented to assess NEDA-3 status. Data were analyzed using Statistical Package for Social Sciences, version 22.

RESULTS

NEDA-3 status was achieved in 41 (33.6%) patients. The female-to-male ratio for all patients was 1.5:1. Interferon (IFN) was the most commonly prescribed DMT. NEDA-3 status was achieved in 30.9% of patients receiving IFN. Mean baseline Expanded Disability Status Scale in patients who did not achieve NEDA-3 was 2.8±1.8. Patients with ataxia (P = <0.001), sphincter disturbances (P=0.002) and infra-tentorial brain lesions (P=0.03) were less likely to achieve NEDA-3 status. Involvement of pyramidal, cerebellar and more than one system at initial presentation was more frequent in patients who could not achieve NEDA-3 status (P=0.002) CONCLUSION: Less than one third of total patients on IFN as DMT could achieve NEDA-3 status in our cohort of patients which is in agreement with the literature published in the West. We could not properly asses NEDA-3 status for other DMTs in our center due to the very small sample size of patients on these DMTs, and recommend future studies including larger number of patients on DMTs other than IFN. Significant differences were identified between the two groups of patients with respect to attainment of NEDA-3 status, which requires further verification by multicenter prospective studies.

摘要

背景

无疾病活动(NEDA)是一种复合替代指标,用于评估复发缓解型多发性硬化症(RRMS)患者对各种疾病修正治疗(DMT)的反应,涵盖临床和影像学疾病活动。尽管多发性硬化症在沙特阿拉伯(SA)的患病率不断上升,但在 RRMS 的管理中,针对这一重要方面的证据仍然缺乏。本研究旨在确定接受 DMT(主要为干扰素)治疗的 RRMS 患者达到 NEDA-3 状态的患病率,并描述影响其达到 NEDA-3 状态的因素。

方法

这是一项在获得机构伦理批准后在法赫德国王大学医院进行的回顾性、横断面研究。回顾性分析了 119 例 RRMS 患者的电子病历。记录初始表现时的临床表现、治疗后复发、残疾进展以及随访磁共振成像上新病灶的发展情况,以评估 NEDA-3 状态。使用统计软件包 22 版(SPSS 22)分析数据。

结果

41 例(33.6%)患者达到了 NEDA-3 状态。所有患者的男女比例为 1.5:1。干扰素(IFN)是最常用的 DMT。接受 IFN 治疗的患者中,有 30.9%达到了 NEDA-3 状态。未达到 NEDA-3 状态的患者的基线扩展残疾状况量表(EDSS)平均值为 2.8±1.8。有共济失调(P<0.001)、括约肌功能障碍(P=0.002)和小脑下脑病变(P=0.03)的患者更不可能达到 NEDA-3 状态。初始表现累及锥体、小脑和一个以上系统的患者更难以达到 NEDA-3 状态(P=0.002)。

结论

在我们的患者队列中,接受 IFN 作为 DMT 的患者中,不到三分之一的患者能够达到 NEDA-3 状态,这与在西方发表的文献一致。由于接受这些 DMT 的患者数量非常少,我们无法对中心内其他 DMT 的 NEDA-3 状态进行适当评估,并建议未来的研究包括更多接受 IFN 以外的 DMT 的患者。两组患者在达到 NEDA-3 状态方面存在显著差异,这需要通过多中心前瞻性研究进一步验证。

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