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迟释富马酸二甲酯相关胃肠道事件的共识管理:德尔菲研究。

Consensus Management of Gastrointestinal Events Associated with Delayed-Release Dimethyl Fumarate: A Delphi Study.

机构信息

Baylor Institute for Immunology Research, Dallas, TX, USA.

NeuroMedical Center Clinic, Baton Rouge, LA, USA.

出版信息

Neurol Ther. 2015 Dec;4(2):137-46. doi: 10.1007/s40120-015-0037-x. Epub 2015 Nov 2.

DOI:10.1007/s40120-015-0037-x
PMID:26525536
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4685868/
Abstract

INTRODUCTION

Delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF) is indicated for the treatment of patients with relapsing multiple sclerosis. Gastrointestinal (GI) adverse events (AEs) occur with DMF therapy.

METHODS

We used a Delphi process to reach consensus among North American clinicians on effective real-world management strategies for GI AEs associated with DMF. Clinicians were asked to complete two rounds of questionnaires developed by a steering committee; consensus in round 2 was attained if ≥70% of respondents agreed on a particular strategy.

RESULTS

Consensus was reached on several strategies to manage GI AEs, including administering DMF with food, slow titration, dose reduction, and use of symptomatic therapies.

CONCLUSION

These consensus strategies provide clinicians with information on real-world approaches used to address the tolerability of DMF in patients with multiple sclerosis.

FUNDING

Biogen.

摘要

简介

延迟释放富马酸二甲酯(DMF,也称为耐胃酸 DMF)用于治疗复发型多发性硬化症患者。DMF 治疗会引起胃肠道(GI)不良反应(AE)。

方法

我们使用 Delphi 流程在北美临床医生中就与 DMF 相关的 GI AE 的有效真实世界管理策略达成共识。临床医生被要求完成由指导委员会制定的两轮问卷;如果≥70%的应答者同意特定策略,则在第二轮中达成共识。

结果

针对管理 GI AE 的几种策略达成了共识,包括随餐服用 DMF、缓慢滴定、剂量减少和使用对症治疗。

结论

这些共识策略为临床医生提供了有关用于解决多发性硬化症患者 DMF 耐受性的真实世界方法的信息。

资金来源

Biogen。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c4f/4685868/5b0d58dac8d9/40120_2015_37_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c4f/4685868/e15f960a30e9/40120_2015_37_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c4f/4685868/83d8d640c2a1/40120_2015_37_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c4f/4685868/616b34653567/40120_2015_37_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c4f/4685868/5b0d58dac8d9/40120_2015_37_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c4f/4685868/e15f960a30e9/40120_2015_37_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c4f/4685868/83d8d640c2a1/40120_2015_37_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c4f/4685868/616b34653567/40120_2015_37_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c4f/4685868/5b0d58dac8d9/40120_2015_37_Fig4_HTML.jpg

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本文引用的文献

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Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel.管理与缓释富马酸二甲酯相关的潮红和胃肠道事件:一个国际专家小组的经验
Mult Scler Relat Disord. 2014 Jul;3(4):513-9. doi: 10.1016/j.msard.2014.03.003. Epub 2014 Apr 1.
2
Efficacy of delayed-release dimethyl fumarate in relapsing-remitting multiple sclerosis: integrated analysis of the phase 3 trials.延迟释放二甲基富马酸酯在复发缓解型多发性硬化症中的疗效:3 期试验的综合分析。
Ann Clin Transl Neurol. 2015 Feb;2(2):103-18. doi: 10.1002/acn3.148. Epub 2014 Dec 4.
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Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis.
富马酸二甲酯作为一种新型口服免疫调节疗法用于多发性硬化的复发形式:新兴数据的综述。
Drug Des Devel Ther. 2022 Nov 10;16:3915-3927. doi: 10.2147/DDDT.S236926. eCollection 2022.
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Health-Related Quality of Life with Diroximel Fumarate in Patients with Relapsing Forms of Multiple Sclerosis: Findings from Qualitative Research Using Patient Interviews.二羟麦角隐亭富马酸盐治疗复发性多发性硬化症患者的健康相关生活质量:采用患者访谈进行定性研究的结果。
Adv Ther. 2022 Jul;39(7):3199-3213. doi: 10.1007/s12325-022-02164-8. Epub 2022 May 13.
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Dimethyl fumarate treatment for psoriasis in a real-life setting: A multicentric retrospective study.在真实环境下用富马酸二甲酯治疗银屑病:一项多中心回顾性研究。
Dermatol Ther. 2021 Sep;34(5):e15066. doi: 10.1111/dth.15066. Epub 2021 Aug 2.
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口服 BG-12 治疗复发型多发性硬化症的安慰剂对照 3 期研究。
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The Global Adherence Project (GAP): a multicenter observational study on adherence to disease-modifying therapies in patients with relapsing-remitting multiple sclerosis.全球依从性项目(GAP):一项关于复发缓解型多发性硬化症患者对疾病修正治疗依从性的多中心观察性研究。
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A review of disease-modifying therapies for MS: maximizing adherence and minimizing adverse events.多发性硬化症疾病修正疗法综述:最大化依从性并最小化不良事件
Curr Med Res Opin. 2009 Jan;25(1):77-92. doi: 10.1185/03007990802569455.