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关于使用克拉屈滨的专家共识实用建议。

Expert-Agreed Practical Recommendations on the Use of Cladribine.

作者信息

Meca-Lallana Virginia, García Domínguez José M, López Ruiz Rocío, Martín-Martínez Jesús, Arés Luque Adrián, Hernández Pérez Miguel A, Prieto González José M, Landete Pascual Lamberto, Sastre-Garriga Jaume

机构信息

Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario "La Princesa", Madrid, Spain.

Demyelinating Diseases Unit, Hospital Gregorio Marañón, Madrid, Spain.

出版信息

Neurol Ther. 2022 Dec;11(4):1475-1488. doi: 10.1007/s40120-022-00394-0. Epub 2022 Sep 6.

DOI:10.1007/s40120-022-00394-0
PMID:36068429
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9447968/
Abstract

Cladribine is a disease-modifying selective immune reconstitution oral therapy for adult patients with highly active relapsing multiple sclerosis (RMS). It was approved in the USA in 2019 and in Europe in 2017, thus there are still gaps in existing guidelines for using cladribine tablets in clinical practice. Nine experts with extensive experience in managing patients with multiple sclerosis in Spain identified some of the unanswered questions related to the real-life use of cladribine tablets. They reviewed the available clinical trial data and real-world evidence, including their own experiences of using cladribine, over the course of three virtual meetings held between November 2020 and January 2021. This article gathers their practical recommendations to aid treatment decision-making and optimise the use of cladribine tablets in patients with RMS. The consensus recommendations cover the following areas: candidate patient profiles, switching strategies (to and from cladribine), managing response to cladribine and safety considerations.

摘要

克拉屈滨是一种用于治疗复发型多发性硬化症(RMS)成年患者的病情改善型选择性免疫重建口服疗法。它于2019年在美国获批,2017年在欧洲获批,因此在临床实践中使用克拉屈滨片的现有指南仍存在空白。西班牙九位在管理多发性硬化症患者方面经验丰富的专家确定了一些与克拉屈滨片实际应用相关的未解答问题。他们在2020年11月至2021年1月期间举行的三次虚拟会议上,回顾了可用的临床试验数据和真实世界证据,包括他们自己使用克拉屈滨的经验。本文收集了他们的实用建议,以帮助进行治疗决策,并优化RMS患者对克拉屈滨片的使用。共识建议涵盖以下方面:候选患者概况、转换策略(换用和停用克拉屈滨)、应对克拉屈滨的反应以及安全考量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb5d/9588129/7199ec37c98b/40120_2022_394_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb5d/9588129/9f98cceb232f/40120_2022_394_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb5d/9588129/7199ec37c98b/40120_2022_394_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb5d/9588129/9f98cceb232f/40120_2022_394_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb5d/9588129/7199ec37c98b/40120_2022_394_Fig2_HTML.jpg

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本文引用的文献

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J Neurol Neurosurg Psychiatry. 2023 Jan;94(1):19-22. doi: 10.1136/jnnp-2021-327612. Epub 2021 Oct 20.
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Treatment-emergent adverse events occurring early in the treatment course of cladribine tablets in two phase 3 trials in multiple sclerosis.在两项针对多发性硬化症的3期试验中,氯法拉滨片治疗过程早期出现的治疗中突发不良事件。
Mult Scler J Exp Transl Clin. 2021 Jul 13;7(3):20552173211024298. doi: 10.1177/20552173211024298. eCollection 2021 Jul-Sep.
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确定多发性硬化症中克拉屈滨的处方模式:一项意大利多中心研究。
Ther Adv Neurol Disord. 2025 Jan 8;18:17562864241304212. doi: 10.1177/17562864241304212. eCollection 2025.
4
Cladribine Use in Relapsing Multiple Sclerosis After 8-10 Years: Two Case Reports of Patients From the ORACLE-MS Study.8 - 10年后复发型多发性硬化症中克拉屈滨的应用:来自ORACLE - MS研究的两例患者报告
Cureus. 2024 Nov 28;16(11):e74671. doi: 10.7759/cureus.74671. eCollection 2024 Nov.
5
Making Information About Cladribine Tablets Accessible to People with Multiple Sclerosis: A Patient-Survey-Led Narrative Review for Healthcare Professionals.让多发性硬化症患者能够获取有关克拉屈滨片的信息:一项以患者调查为导向的医疗专业人员叙述性综述
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Narrative Review on the Use of Cladribine Tablets as Exit Therapy for Stable Elderly Patients with Multiple Sclerosis.关于使用克拉屈滨片作为稳定期老年多发性硬化症患者退出治疗的叙述性综述。
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