Stewart Thomas M, Tran Zung Vu
Rocky Mountain MS Center, Westminster, CO, USA (TMS), and the Department of Biostatistics & Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA (ZVT).
Int J MS Care. 2012 Spring;14(1):46-53. doi: 10.7224/1537-2073-14.1.46.
Although injection-site reactions (ISRs) occur with US Food and Drug Administration-approved injectable disease-modifying therapies (DMTs) for multiple sclerosis, there are currently few reports of real-world data on ISR management strategies or possible correlations between ISRs and patient demographics, disease characteristics, and missed injections. Patient-reported data on the use of DMTs, patient demographic and disease characteristics, missed injections, and ISR reduction strategies were collected via e-mail, a patient registry (www.ms-cam.org), and a Web-based survey. Of the 1380 respondents, 1201 (87%) indicated that they had used injectable DMTs, of whom 377 (31%) had used intramuscular (IM) interferon beta-1a (IFNβ-1a), 172 (14%) had used subcutaneous (SC) IFNβ-1a, 183 (15%) had used SC IFNβ-1b, and 469 (39%) had used glatiramer acetate (GA). The majority of respondents were older (73% were ≥40 years), female (79%), married or living with a partner (72%), white (94%), and nonsmoking (82%). Injection-site reaction incidence, grouped according to severity, varied among DMTs, with IM IFNβ-1a causing significantly (P < .001) fewer mild, moderate, or severe ISRs than the other therapies. Female sex and younger age were significantly (P < .05) associated with more moderate ISRs among users of IM IFNβ-1a, SC IFNβ-1b, and GA. Nonwhites reported severe ISRs more often than whites. For all DMTs injection-site massage and avoidance of sensitive sites were the most frequently used strategies to minimize ISRs. These data may help identify patients with characteristics associated with a higher risk for ISRs, allowing health-care professionals to provide anticipatory guidance to patients at risk for decreased adherence or discontinuation.
尽管美国食品药品监督管理局批准的用于治疗多发性硬化症的注射用疾病修正疗法（DMTs）会引发注射部位反应（ISRs），但目前关于ISR管理策略或ISRs与患者人口统计学特征、疾病特征及漏注之间可能存在的相关性的真实世界数据报道较少。通过电子邮件、患者登记系统（www.ms-cam.org）和基于网络的调查收集了患者报告的关于DMTs使用情况、患者人口统计学和疾病特征、漏注情况以及ISR减轻策略的数据。在1380名受访者中，1201人（87%）表示曾使用过注射用DMTs，其中377人（31%）使用过肌肉注射（IM）干扰素β-1a（IFNβ-1a），172人（14%）使用过皮下注射（SC）IFNβ-1a，183人（15%）使用过SC IFNβ-1b，469人（39%）使用过醋酸格拉替雷（GA）。大多数受访者年龄较大（73%年龄≥40岁），为女性（79%），已婚或与伴侣同住（72%），为白人（94%），且不吸烟（82%）。根据严重程度分组的注射部位反应发生率在不同DMTs之间有所差异，IM IFNβ-1a引发的轻度、中度或重度ISRs明显（P < .001）少于其他疗法。在使用IM IFNβ-1a、SC IFNβ-1b和GA的患者中，女性和较年轻的年龄与更中度的ISRs显著（P < .05）相关。非白人比白人更常报告严重的ISRs。对于所有DMTs，注射部位按摩和避免敏感部位是最常使用的减轻ISRs的策略。这些数据可能有助于识别具有与较高ISR风险相关特征的患者，使医护人员能够为有依从性降低或停药风险的患者提供预期指导。
