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聚乙二醇干扰素β-1a相关流感样症状和注射部位反应的管理策略:采用德尔菲技术获取建议

Management Strategies for Flu-Like Symptoms and Injection-Site Reactions Associated with Peginterferon Beta-1a: Obtaining Recommendations Using the Delphi Technique.

作者信息

Halper June, Centonze Diego, Newsome Scott D, Huang DeRen, Robertson Christopher, You Xiaojun, Sabatella Guido, Evilevitch Vladimir, Leahy Leslie

出版信息

Int J MS Care. 2016 Jul-Aug;18(4):211-8. doi: 10.7224/1537-2073.2015-042.

Abstract

BACKGROUND

Flu-like symptoms (FLSs) and injection-site reactions (ISRs) have been reported with interferon beta treatments for multiple sclerosis (MS). We sought to obtain consensus on the characteristics/management of FLSs/ISRs in patients with relapsing-remitting MS based on experiences from the randomized, placebo-controlled ADVANCE study of peginterferon beta-1a.

METHODS

ADVANCE investigators with a predefined number of enrolled patients were eligible to participate in a consensus-generating exercise using a modified Delphi method. An independent steering committee oversaw the development of two sequential Delphi questionnaires. An average rating (AR) of 2.7 or more was defined as consensus a priori.

RESULTS

Thirty and 29 investigators (ie, responders) completed questionnaires 1 and 2, respectively, representing 374 patients from ADVANCE. Responders reported that the incidence/duration of FLSs/ISRs in their typical patient generally declined after 3 months of treatment. Responders reached consensus that FLSs typically last up to 24 hours (AR = 3.17) and have mild/moderate effects on activities of daily living (AR = 3.34). Patients should initiate acetaminophen/nonsteroidal anti-inflammatory drug treatment on a scheduled basis (AR = 3.31) and change the timing of injection (AR = 3.28) to manage FLSs. Injection-site rotation/cooling and drug administration at room temperature (all AR ≥ 3.10) were recommended for managing ISRs. Patient education on FLSs/ISRs was advocated before treatment initiation.

CONCLUSIONS

Delphi responders agreed on the management strategies for FLSs/ISRs and agreed that patient education is critical to set treatment expectations and promote adherence.

摘要

背景

已有报告称,使用干扰素β治疗多发性硬化症(MS)会出现类流感症状(FLS)和注射部位反应(ISR)。我们试图基于聚乙二醇化干扰素β-1a的随机、安慰剂对照ADVANCE研究的经验,就复发缓解型MS患者中FLS/ISR的特征/管理达成共识。

方法

纳入预定数量患者的ADVANCE研究调查人员有资格使用改良的德尔菲法参与共识生成活动。一个独立的指导委员会监督了两份连续的德尔菲调查问卷的制定。平均评分(AR)2.7或更高被预先定义为达成共识。

结果

分别有30名和29名调查人员(即应答者)完成了问卷1和问卷2,代表了来自ADVANCE研究的374名患者。应答者报告称,在治疗3个月后,其典型患者中FLS/ISR的发生率/持续时间通常会下降。应答者达成共识,FLS通常持续长达24小时(AR = 3.17),对日常生活活动有轻度/中度影响(AR = 3.34)。患者应定期开始使用对乙酰氨基酚/非甾体抗炎药治疗(AR = 3.31)并改变注射时间(AR = 3.28)来管理FLS。建议采用注射部位轮换/冷敷以及在室温下给药(所有AR≥3.10)来管理ISR。提倡在开始治疗前对患者进行FLS/ISR方面的教育。

结论

德尔菲法应答者就FLS/ISR的管理策略达成了一致,并一致认为患者教育对于设定治疗预期和促进依从性至关重要。

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本文引用的文献

1
Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel.
Mult Scler Relat Disord. 2014 Jul;3(4):513-9. doi: 10.1016/j.msard.2014.03.003. Epub 2014 Apr 1.
2
Pegylated interferon β-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study.
Lancet Neurol. 2014 Jul;13(7):657-65. doi: 10.1016/S1474-4422(14)70068-7. Epub 2014 Apr 30.
4
Practice patterns of US neurologists in patients with SPMS and PPMS: A consensus study.
Neurol Clin Pract. 2012 Mar;2(1):58-66. doi: 10.1212/CPJ.0b013e31824cb0ac.
5
Narrative review of the literature on adherence to disease-modifying therapies among patients with multiple sclerosis.
J Manag Care Pharm. 2013 Jan-Feb;19(1 Suppl A):S24-40. doi: 10.18553/jmcp.2013.19.s1.S24.
6
Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: a systematic review.
Mult Scler. 2012 Dec;18(12):1705-17. doi: 10.1177/1352458512438239. Epub 2012 Feb 27.
8
Injectable disease-modifying therapy for relapsing-remitting multiple sclerosis: a review of adherence data.
J Neurosci Nurs. 2010 Oct;42(5 Suppl):S5-9. doi: 10.1097/jnn.0b013e3181ee1240.
10
Factors that influence adherence with disease-modifying therapy in MS.
J Neurol. 2009 Apr;256(4):568-76. doi: 10.1007/s00415-009-0096-y. Epub 2009 Apr 27.

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