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首页> 外文期刊>BMC Neurology >Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study
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Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study

机译：自我评估皮下干扰素β-1a注射在复发性多发性硬化中的新型电子设备的患者评价适用性：一项国际，单臂，多中心，IIIb期研究

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Background Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adherence. This study was performed to assess the suitability of a new electronic device for the subcutaneous (sc) administration of interferon (IFN) beta-1a, 44 mcg three times weekly, for relapsing MS. Methods In this Phase IIIb, multicentre, single-arm study, patients with relapsing MS who had been consistently self-injecting sc IFN beta-1a using an autoinjector for at least 6 weeks were taught to use the new device and self-administered treatment for 12 weeks thereafter. Patient-rated suitability of the device was assessed at the end of Week 12 using the Patient User Trial Questionnaire. Patient satisfaction with, and evaluation of, the injection process was assessed using the MS Treatment Concern Questionnaire. Trainers evaluated the device using the Trainer User Trial Questionnaire. Results At Week 12, 71.6% (73/102) of patients considered the device 'very suitable' or 'suitable' for self-injection; 92.2% (94/102) reported some degree of suitability and only 7.8% (8/102) found the device 'not at all suitable'. At Weeks?4, 8 and 12, most patients reported that injection preparation and clean-up, performing injections and ease of device use in the previous 4 weeks compared favourably with, or was equivalent to, their previous experience of self-injection. Injection-related pain, injection reactions and 'flu-like' symptoms remained stable over the 12 weeks. Each device feature was rated 'very useful' or 'useful' by at least 80% of patients. All trainers and 95.2% (99/104) of patients found device functions 'very easy' or 'easy' to use. Overall convenience was considered the most important benefit of the device. Conclusions Most patients considered the new electronic injection device suitable for the sc injection of IFN beta-1a. They found the device easy to use with useful features, and reported benefits such as overall convenience. The device may, therefore, increase treatment adherence in patients with MS, particularly those with injection-related issues. Trial registration NCT00735007
机译：背景技术多发性硬化症（MS）当前需要长期使用可改变病情的药物进行治疗，胃肠外给药每天最多一次。定期自我注射的需求可能成为许多患者治疗的障碍。自动注射器可以帮助患者克服自我注射的问题或疑虑，因此可以改善治疗依从性。进行这项研究的目的是评估一种新的电子设备，每周三次，每次44 mcg，皮下（sc）施用干扰素（IFN）beta-1a，用于复发性MS。方法在该IIIb期，多中心，单臂研究中，一直使用自动注射器持续自我注射sc IFN beta-1a至少6周的复发性MS患者被教导使用该新装置并自行治疗此后12周。在第12周结束时，使用“患者用户试验问卷”评估了该设备对患者的适应性。使用“ MS治疗关注问卷”评估患者对注射过程的满意度和评估。培训师使用“培训师用户试用问卷”对设备进行了评估。结果在第12周，有71.6％（73/102）的患者认为该设备“非常适合”或“适合”自我注射; 92.2％（94/102）表示有一定程度的适用性，只有7.8％（8/102）认为该设备“根本不合适”。在第4周，第8周和第12周，大多数患者报告说，前4周的注射准备和清理，进行注射以及设备使用简便性与他们以前的自我注射经验相比，是有利的，或者是等同的。注射相关的疼痛，注射反应和“流感样”症状在12周内保持稳定。至少80％的患者将每个设备功能评定为“非常有用”或“有用”。所有培训师和95.2％（99/104）的患者都发现设备功能“非常容易”或“易于”使用。整体便利性被认为是该设备最重要的好处。结论大多数患者认为新的电子注射装置适合于皮下注射IFN beta-1a。他们发现该设备易于使用且具有有用的功能，并报告了诸如整体便利性之类的好处。因此，该设备可以增加MS患者的治疗依从性，尤其是那些有注射相关问题的患者。试用注册NCT00735007

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