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药物警戒学在多发性硬化症治疗中的应用:中枢神经系统并发症的早期识别。

Pharmacovigilance during treatment of multiple sclerosis: early recognition of CNS complications.

机构信息

Department of Neurology, MS Center Amsterdam, Neuroscience Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands

Department of Radiology & Nuclear Medicine, MS Center Amsterdam, Neuroscience Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.

出版信息

J Neurol Neurosurg Psychiatry. 2021 Feb;92(2):177-188. doi: 10.1136/jnnp-2020-324534. Epub 2020 Nov 23.

DOI:10.1136/jnnp-2020-324534
PMID:33229453
Abstract

An increasing number of highly effective disease-modifying therapies for people with multiple sclerosis (MS) have recently gained marketing approval. While the beneficial effects of these drugs in terms of clinical and imaging outcome measures is welcomed, these therapeutics are associated with substance-specific or group-specific adverse events that include severe and fatal complications. These adverse events comprise both infectious and non-infectious complications that can occur within, or outside of the central nervous system (CNS). Awareness and risk assessment strategies thus require interdisciplinary management, and robust clinical and paraclinical surveillance strategies. In this review, we discuss the current role of MRI in safety monitoring during pharmacovigilance of patients treated with (selective) immune suppressive therapies for MS. MRI, particularly brain MRI, has a pivotal role in the early diagnosis of CNS complications that potentially are severely debilitating and may even be lethal. Early recognition of such CNS complications may improve functional outcome and survival, and thus knowledge on MRI features of treatment-associated complications is of paramount importance to MS clinicians, but also of relevance to general neurologists and radiologists.

摘要

越来越多的多发性硬化症 (MS) 患者的高效疾病修正治疗方法最近获得了市场批准。虽然这些药物在临床和影像学结果方面的有益效果受到欢迎,但这些治疗方法与特定物质或特定群体的不良事件相关,包括严重和致命的并发症。这些不良事件包括中枢神经系统 (CNS) 内或外发生的感染性和非感染性并发症。因此,意识和风险评估策略需要多学科管理,以及强大的临床和辅助临床监测策略。在这篇综述中,我们讨论了 MRI 在接受(选择性)免疫抑制治疗 MS 患者药物警戒期间安全性监测中的当前作用。MRI,特别是脑 MRI,在早期诊断潜在严重致残甚至致命的 CNS 并发症方面发挥着关键作用。早期识别此类 CNS 并发症可能会改善功能结局和生存率,因此,了解与治疗相关的并发症的 MRI 特征对 MS 临床医生至关重要,但对一般神经科医生和放射科医生也很重要。

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