Esclerosis múltiple

精索硬化症
  • 文章类型: Practice Guideline
    西班牙神经病学会脱髓鞘疾病研究小组关于多发性硬化症(MS)治疗的最后一份共识声明于2016年发布。尽管采取的许多立场仍然有效,MS的管理和治疗发生了重大变化,这既是由于具有不同作用机制的新药的批准,也是由于先前固定概念的演变。这使得针对怀孕和疫苗接种等特定情况采取了新的方法,在临床决策中加入新的变量,例如早期使用高效的疾病改善疗法(DMT),考虑患者的观点,以及远程监控等新技术的使用。鉴于这些变化,这份最新的共识声明,根据德尔菲法开发,试图反映MS患者管理的新范式,基于现有的科学证据和参与者的临床专业知识。最重要的建议是,在放射学孤立综合征持续放射学活动的患者中开始免疫调节DMT。考虑患者的观点,术语“治疗路线”不再用于DMT的分类(>90%共识)。在MS诊断后,应根据预后不良因素的存在/不存在(无论是流行病学,临床,放射学,或生物标志物)用于新复发或残疾进展的发生;从疾病发作开始,可以考虑使用高效DMT。
    The last consensus statement of the Spanish Society of Neurology\'s Demyelinating Diseases Study Group on the treatment of multiple sclerosis (MS) was issued in 2016. Although many of the positions taken remain valid, there have been significant changes in the management and treatment of MS, both due to the approval of new drugs with different action mechanisms and due to the evolution of previously fixed concepts. This has enabled new approaches to specific situations such as pregnancy and vaccination, and the inclusion of new variables in clinical decision-making, such as the early use of high-efficacy disease-modifying therapies (DMT), consideration of the patient\'s perspective, and the use of such novel technologies as remote monitoring. In the light of these changes, this updated consensus statement, developed according to the Delphi method, seeks to reflect the new paradigm in the management of patients with MS, based on the available scientific evidence and the clinical expertise of the participants. The most significant recommendations are that immunomodulatory DMT be started in patients with radiologically isolated syndrome with persistent radiological activity, that patient perspectives be considered, and that the term \"lines of therapy\" no longer be used in the classification of DMTs (> 90% consensus). Following diagnosis of MS, the first DMT should be selected according to the presence/absence of factors of poor prognosis (whether epidemiological, clinical, radiological, or biomarkers) for the occurrence of new relapses or progression of disability; high-efficacy DMTs may be considered from disease onset.
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  • 文章类型: Journal Article
    背景:Alemtuzumab是一种被欧洲药品管理局批准为用于治疗复发缓解型多发性硬化症的疾病缓解药物的高效药物。
    目的:起草了一份关于阿仑珠单抗在西班牙常规临床实践中的管理的共识文件。
    方法:一组多发性硬化症专家回顾了2017年12月之前发表的关于阿仑珠单抗治疗多发性硬化症患者的文章。纳入的研究评估了药物的疗效,有效性,和安全性;筛查感染和疫苗接种;以及管理和监测方面。最初提出的建议是由协调小组根据现有证据及其临床经验制定的。协商一致进程分两个阶段进行,集团协议的初始阈值百分比为80%。载有工作组商定的所有建议的最后文件已提交外部审查,协调小组对收到的意见进行了审议。
    结论:本文件旨在用作在常规临床实践中优化阿仑珠单抗管理的工具。
    BACKGROUND: Alemtuzumab is a highly effective drug approved by the European Medicines Agency as a disease-modifying drug for the treatment of relapsing-remitting multiple sclerosis.
    OBJECTIVE: A consensus document was drafted on the management of alemtuzumab in routine clinical practice in Spain.
    METHODS: A group of multiple sclerosis specialists reviewed articles addressing treatment with alemtuzumab in patients with multiple sclerosis and published before December 2017. The included studies assessed the drug\'s efficacy, effectiveness, and safety; screening for infections and vaccination; and administration and monitoring aspects. The initial proposed recommendations were developed by a coordinating group and based on the available evidence and their clinical experience. The consensus process was carried out in 2 stages, with the initial threshold percentage for group agreement established at 80%. The final document with all the recommendations agreed by the working group was submitted for external review and the comments received were considered by the coordinating group.
    CONCLUSIONS: The present document is intended to be used as a tool for optimising the management of alemtuzumab in routine clinical practice.
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  • 文章类型: Journal Article
    BACKGROUND: The recent development of highly effective treatments for multiple sclerosis (MS) and the potential risk of infectious complications require the development of prevention and risk minimisation strategies. Vaccination is an essential element of the management of these patients. This consensus statement includes a series of recommendations and practical scenarios for the vaccination of adult patients with MS who are eligible for highly effective immunosuppressive treatments.
    METHODS: A formal consensus procedure was followed. Having defined the scope of the statement, we conducted a literature search on recommendations for the vaccination of patients with MS and specific vaccination guidelines for immunosuppressed patients receiving biological therapy for other conditions. The modified nominal group technique methodology was used to formulate the recommendations.
    METHODS: Vaccination in patients who are candidates for immunosuppressive therapy should be considered before starting immunosuppressive treatment providing the patient\'s clinical situation allows. Vaccines included in the routine adult vaccination schedule, as well as some specific ones, are recommended depending on the pre-existing immunity status. If immunosuppressive treatment is already established, live attenuated vaccines are contraindicated. For vaccines with a correlate of protection, it is recommended to monitor the serological response in an optimal interval of 1-2 months from the last dose.
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  • 文章类型: Journal Article
    Alemtuzumab是欧洲药品管理局批准的一种高效药物,可作为治疗复发缓解型多发性硬化症的疾病缓解药物。
    在西班牙的常规临床实践中起草了一份关于阿仑珠单抗管理的共识文件。
    一组多发性硬化症专家回顾了关于阿仑妥珠单抗治疗多发性硬化症患者的文章,并在2017年12月之前发表。纳入的研究评估了药物的疗效,有效性,和安全性;筛查感染和疫苗接种;以及管理和监测方面。最初提出的建议是由协调小组根据现有证据及其临床经验制定的。协商一致进程分两个阶段进行,集团协议的初始阈值百分比为80%。载有工作组商定的所有建议的最后文件已提交外部审查,协调小组对收到的意见进行了审议。
    本文件旨在用作在常规临床实践中优化阿仑单抗管理的工具。
    Alemtuzumab is a highly effective drug approved by the European Medicines Agency as a disease-modifying drug for the treatment of relapsing-remitting multiple sclerosis.
    A consensus document was drafted on the management of alemtuzumab in routine clinical practice in Spain.
    A group of multiple sclerosis specialists reviewed articles addressing treatment with alemtuzumab in patients with multiple sclerosis and published before December 2017. The included studies assessed the drug\'s efficacy, effectiveness, and safety; screening for infections and vaccination; and administration and monitoring aspects. The initial proposed recommendations were developed by a coordinating group and based on the available evidence and their clinical experience. The consensus process was carried out in 2 stages, with the initial threshold percentage for group agreement established at 80%. The final document with all the recommendations agreed by the working group was submitted for external review and the comments received were considered by the coordinating group.
    The present document is intended to be used as a tool for optimising the management of alemtuzumab in routine clinical practice.
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  • 文章类型: Journal Article
    With the advent of new disease-modifying drugs, the treatment of multiple sclerosis is becoming increasingly complex. Using consensus statements is therefore advisable. The present consensus statement, which was drawn up by the Spanish Society of Neurology\'s study group for demyelinating diseases, updates previous consensus statements on the disease. The present study lists the medications currently approved for multiple sclerosis and their official indications, and analyses such treatment-related aspects as activity, early treatment, maintenance, follow-up, treatment failure, changes in medication, and special therapeutic situations. This consensus statement includes treatment recommendations for a wide range of demyelinating diseases, from isolated demyelinating syndromes to the different forms of multiple sclerosis, as well as recommendations for initial therapy and changes in drug medication, and additional comments on induction and combined therapy and practical aspects of the use of these drugs.
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  • 文章类型: Consensus Development Conference
    背景:纳他珠单抗治疗在临床试验中非常有效,在复发缓解型多发性硬化症患者的临床实践中非常有效,通过减少复发,减缓疾病进展,并改善磁共振成像模式。然而,该药物还与进行性多灶性白质脑病(PML)的风险相关.关于纳他珠单抗使用的第一个共识声明,2011年出版,已更新为包括诊断程序的新数据,监测正在接受治疗的患者,PML管理,以及其他感兴趣的主题,包括停用那他珠单抗的患者的管理。
    方法:此更新版本遵循了第一个共识中使用的方法。一组西班牙多发性硬化症专家(本文件的作者)审查了所有现有的关于那他珠单抗的文献,并根据他们的临床经验确定了相关主题需要更新。初稿通过了审查周期,直到最终版本完成。
    结论:临床实践中的研究表明,改用那他珠单抗比在免疫调节剂之间切换更有效。他们倾向于早期使用那他珠单抗治疗,而不是在后期使用那他珠单抗作为抢救治疗。虽然这种药非常有效,其潜在的不利影响需要考虑,特别注意患者发展为PML的可能性。神经科医生应仔细解释治疗的风险和益处,将它们与患者可以理解的多发性硬化症的风险进行比较。治疗开始前,应提供实验室测试和磁共振图像,以进行适当的随访。PML的风险应该分层为高,中等,或低根据是否存在抗JC病毒抗体,免疫抑制治疗史,和治疗持续时间。尽管抗JC病毒抗体的存在是一个重要的发现,不应将其视为那他珠单抗的绝对禁忌症.此更新提供了一般性建议,但神经科医师必须利用他们的临床专业知识为每位患者提供个性化的随访。
    BACKGROUND: Natalizumab treatment has been shown to be very efficacious in clinical trials and very effective in clinical practice in patients with relapsing-remitting multiple sclerosis, by reducing relapses, slowing disease progression, and improving magnetic resonance imaging patterns. However, the drug has also been associated with a risk of progressive multifocal leukoencephalopathy (PML). The first consensus statement on natalizumab use, published in 2011, has been updated to include new data on diagnostic procedures, monitoring for patients undergoing treatment, PML management, and other topics of interest including the management of patients discontinuing natalizumab.
    METHODS: This updated version followed the method used in the first consensus. A group of Spanish experts in multiple sclerosis (the authors of the present document) reviewed all currently available literature on natalizumab and identified the relevant topics would need updating based on their clinical experience. The initial draft passed through review cycles until the final version was completed.
    CONCLUSIONS: Studies in clinical practice have demonstrated that changing to natalizumab is more effective than switching between immunomodulators. They favour early treatment with natalizumab rather than using natalizumab in a later stage as a rescue therapy. Although the drug is very effective, its potential adverse effects need to be considered, with particular attention to the patient\'s likelihood of developing PML. The neurologist should carefully explain the risks and benefits of the treatment, comparing them to the risks of multiple sclerosis in terms the patient can understand. Before treatment is started, laboratory tests and magnetic resonance images should be available to permit proper follow-up. The risk of PML should be stratified as high, medium, or low according to presence or absence of anti-JC virus antibodies, history of immunosuppressive therapy, and treatment duration. Although the presence of anti-JC virus antibodies is a significant finding, it should not be considered an absolute contraindication for natalizumab. This update provides general recommendations, but neurologists must use their clinical expertise to provide personalised follow-up for each patient.
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  • 文章类型: Consensus Development Conference
    Treatments for multiple sclerosis therapy are rapidly evolving. It is believed that new drugs will be approved in the near future, thereby changing current indications for treatment. In this context, the Spanish Society of Neurology\'s study group on demyelinating diseases, which evaluates medication use in MS, has decided to draw up a consensus statement on the current indications and guidelines for multiple sclerosis treatment.
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