Halper June, Centonze Diego, Newsome Scott D, Huang DeRen, Robertson Christopher, You Xiaojun, Sabatella Guido, Evilevitch Vladimir, Leahy Leslie
Int J MS Care. 2016 Jul-Aug;18(4):211-8. doi: 10.7224/1537-2073.2015-042.
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.
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.
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.
Delphi responders agreed on the management strategies for FLSs/ISRs and agreed that patient education is critical to set treatment expectations and promote adherence.
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。
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。
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。
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。