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一项使用 RebiSmart™ 的青少年多发性硬化症患者自我管理干扰素-β1a 的自我报告和父母报告的生活质量的多中心、观察性、前瞻性研究——FUTURE 研究。

A multicenter, observational, prospective study of self- and parent-reported quality of life in adolescent multiple sclerosis patients self-administering interferon-β1a using RebiSmart™-the FUTURE study.

机构信息

Azienda Ospedaliera S. Antonio Abate, Gallarate, Italy.

AOU S. Luigi Gonzaga Neurologia 2 CRESM, Orbassano, Italy.

出版信息

Neurol Sci. 2017 Nov;38(11):1999-2005. doi: 10.1007/s10072-017-3091-6. Epub 2017 Aug 22.

DOI:10.1007/s10072-017-3091-6
PMID:28831635
Abstract

Besides the impact of disease per se, the use of immunomodulatory therapies in adolescents with relapsing-remitting multiple sclerosis (RRMS) may have an effect on quality of life (QL). The FUTURE (Quality of liFe in adolescent sUbjecTs affected by mUltiple sclerosis treated with immunomodulatoRy agEnt using self-injecting device) study was designed to evaluate the changes in QL of Italian adolescents with RRMS receiving treatment with IFN-β1a (Rebif; 22 μg), administered subcutaneously three times weekly using the RebiSmart™ electronic autoinjection device over a 52-week period. Fifty adolescents with RRMS were enrolled and 40 completed the study. Changes from baseline to end of treatment (EoT) in adolescent self-reported and parent-reported QL were assessed using the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL), which has been validated for use in pediatric MS and for which an Italian version is available. The adolescent self-reported total PedsQL4.0 score and all of its subscales tended to increase from baseline to EoT, the only exception being "Emotional functioning." In parent-reported measures, the total PedsQL4.0 score increased significantly from baseline to EoT (+ 5.27 points, p = 0.041). Significant increases were also evident for parent-reported "Psychosocial health summary score" (+ 5.90 points; p = 0.015) and "School functioning" (+ 7.84 points; p = 0.029). Our results indicate that adolescents with RRMS using the electronic injection device RebiSmart™ for self-administration of Rebif® can experience long-term improvements in QL.

摘要

除疾病本身的影响外,免疫调节疗法在复发缓解型多发性硬化症(RRMS)青少年中的应用可能会对生活质量(QL)产生影响。FUTURE(使用自我注射装置接受免疫调节药物治疗的多发性硬化症青少年的生活质量)研究旨在评估接受 IFN-β1a(Rebif;22μg)治疗的意大利 RRMS 青少年的 QL 变化,每周三次皮下使用 RebiSmart™电子自动注射装置治疗 52 周。50 名 RRMS 青少年入选,40 名完成研究。使用已在儿科多发性硬化症中验证并具有意大利语版本的儿科生活质量量表多维疲劳量表(PedsQL)评估青少年自我报告和家长报告的 QL 从基线到治疗结束(EoT)的变化。青少年自我报告的 PedsQL4.0 总分及其所有子量表均倾向于从基线到 EoT 增加,唯一的例外是“情绪功能”。在家长报告的测量中,PedsQL4.0 总分从基线到 EoT 显著增加(+5.27 分,p=0.041)。家长报告的“心理社会健康综合评分”(+5.90 分;p=0.015)和“学校功能”(+7.84 分;p=0.029)也有显著增加。我们的结果表明,使用 RebiSmart™电子注射装置为自己皮下注射 Rebif®的 RRMS 青少年可以长期改善 QL。

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