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多发性硬化症中的芬戈莫德:习惯性实践中的使用概况。

Fingolimod in multiple sclerosis: profile of use in habitual practice.

机构信息

Pharmacy Service, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC). Sergas. Universidade da Coruña (UDC), A Coruña, Spain

Pharmacy Service, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC). Sergas. Universidade da Coruña (UDC), A Coruña, Spain.

出版信息

Eur J Hosp Pharm. 2020 Nov;27(6):346-349. doi: 10.1136/ejhpharm-2018-001840. Epub 2019 Mar 18.

DOI:10.1136/ejhpharm-2018-001840
PMID:33097618
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7856107/
Abstract

OBJECTIVES

Fingolimod is the first oral drug indicated in monotherapy as a modifier of the course of very active relapsing-remitting multiple sclerosis (RRMS). The safety profile of fingolimod is well established in clinical trials and post-marketing studies. Our objective was to study the profile of fingolimod use in our health area.

METHODS

A retrospective, observational, descriptive study was performed on the use of fingolimod in adult patients diagnosed with RRMS between January 2015 and February 2017 or until suspension of treatment in a reference hospital in north-western Spain.

RESULTS

A total of 55 patients were included with a mean±SD time of treatment with fingolimod of 26±14.6 months (range 2-53). Thirteen patients permanently discontinued the treatment (10 due to outbreaks/disease progression and 3 due to adverse effects). No statistically significant differences were found between the percentage of patients who discontinued fingolimod and who had received only one previous treatment and those who had received two or more treatments. No cases of symptomatic bradycardia were reported.

CONCLUSIONS

Fingolimod is a safe treatment for patients with multiple sclerosis.

摘要

目的

芬戈莫德是首个被批准用于治疗极活跃复发缓解型多发性硬化症(RRMS)的单药疗法的口服药物。芬戈莫德在临床试验和上市后研究中的安全性已得到充分证实。我们的目的是研究芬戈莫德在我们的医疗区域的使用情况。

方法

对 2015 年 1 月至 2017 年 2 月期间在西班牙西北部一家参考医院被诊断为 RRMS 的成年患者使用芬戈莫德的情况进行了回顾性、观察性、描述性研究,或直至停止治疗。

结果

共纳入 55 例患者,平均±SD 芬戈莫德治疗时间为 26±14.6 个月(范围 2-53)。13 例患者永久性停药(10 例因爆发/疾病进展,3 例因不良反应)。接受过一次以上治疗的患者与仅接受过一次治疗的患者相比,停药的比例无统计学差异。未报告有症状性心动过缓的病例。

结论

芬戈莫德是一种治疗多发性硬化症患者的安全治疗方法。

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本文引用的文献

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Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.实践指南推荐摘要:多发性硬化症成人的疾病修正治疗:美国神经病学学会指南制定、传播和实施小组委员会的报告。
Neurology. 2018 Apr 24;90(17):777-788. doi: 10.1212/WNL.0000000000005347.
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ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis.ECTRIMS/EAN 多发性硬化症药物治疗指南
Mult Scler. 2018 Feb;24(2):96-120. doi: 10.1177/1352458517751049. Epub 2018 Jan 20.
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Safety and tolerability of fingolimod in patients with relapsing-remitting multiple sclerosis: results of an open-label clinical trial in Italy.芬戈莫德在复发缓解型多发性硬化症患者中的安全性和耐受性:意大利一项开放标签临床试验的结果
Neurol Sci. 2017 Jan;38(1):53-59. doi: 10.1007/s10072-016-2701-z. Epub 2016 Oct 18.
4
[Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Galicia].[芬戈莫德:常规临床实践中的有效性和安全性。加利西亚的一项观察性、回顾性、多中心研究]
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Update on the cardiovascular profile of fingolimod in the therapy of relapsing-remitting multiple sclerosis (MS).芬戈莫德治疗复发缓解型多发性硬化症(MS)的心血管状况最新进展。
Mult Scler Relat Disord. 2016 Jul;8:19-26. doi: 10.1016/j.msard.2016.04.002. Epub 2016 Apr 21.
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Consensus statement on the treatment of multiple sclerosis by the Spanish Society of Neurology in 2016.西班牙神经病学学会2016年关于多发性硬化症治疗的共识声明。
Neurologia. 2017 Mar;32(2):113-119. doi: 10.1016/j.nrl.2016.02.026. Epub 2016 May 6.
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The Direct Effects of Fingolimod in the Central Nervous System: Implications for Relapsing Multiple Sclerosis.芬戈莫德在中枢神经系统中的直接作用:对复发型多发性硬化症的影响
CNS Drugs. 2016 Feb;30(2):135-47. doi: 10.1007/s40263-015-0297-0.
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Safety and efficacy of fingolimod in clinical practice: The experience of an academic center in the Middle East.芬戈莫德在临床实践中的安全性和有效性:中东某学术中心的经验。
J Neuroimmunol. 2015 Dec 15;289:93-7. doi: 10.1016/j.jneuroim.2015.10.015. Epub 2015 Oct 26.
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Real-world use of fingolimod in patients with relapsing remitting multiple sclerosis: a retrospective study using the national multiple sclerosis registry in Kuwait.芬戈莫德在复发缓解型多发性硬化症患者中的真实世界应用:一项使用科威特国家多发性硬化症登记处数据的回顾性研究
CNS Drugs. 2014 Sep;28(9):817-24. doi: 10.1007/s40263-014-0185-z.