Zettl Uwe Klaus, Bauer-Steinhusen Ulrike, Glaser Thomas, Czekalla Jörg, Hechenbichler Klaus, Limmroth Volker, Hecker Michael
Department of Neurology, Neuroimmunology Section, University of Rostock, Rostock, Germany.
Neurology, Immunology, and Ophthalmology, Bayer Vital GmbH, Leverkusen, Germany.
Adv Ther. 2016 May;33(5):834-47. doi: 10.1007/s12325-016-0325-6. Epub 2016 Apr 18.
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system requiring long-term treatment, which is often hampered by non-adherence to self-applicable therapies, provoking continued disease activity and health care system burdens. This study assessed the influence of a personal digital assistant (PDA) with diary function (n = 339 patients) on persistence and adherence to an interferon beta treatment regimen in comparison to a paper patient diary (n = 330 patients).
Patients who recently started with subcutaneous injections of interferon beta-1b were recruited in this prospective, non-interventional, national cohort study for an observational period of 2 years after successful completion of the initial dose escalation.
Therapy persistence as assessed by the drop-out rate within 104 weeks was about 50% in both study cohorts. In male patients, the drop-out rate was 10% lower when using a PDA compared to the non-PDA group. Use of a PDA with an injection reminder function increased adherence to the injection schedule (every other day) by a mean of 24.5 injections over 24 months in comparison to use of a PDA without injection reminder function.
Persistence in this study was in the published range of observational MS studies. Furthermore, in male patients continuation of therapy might be positively influenced by use of a PDA, and both female and male patients might benefit from an integrated reminder function. In conclusion, electronic diaries reminding patients of upcoming injections can promote an improved adherence to MS therapy.
ClinicalTrials.gov identifier: NCT00902135.
Bayer Vital GmbH.
多发性硬化症（MS）是一种中枢神经系统的慢性炎症性疾病，需要长期治疗，但患者往往不坚持自行适用的治疗方法，这会导致疾病持续活动并给医疗保健系统带来负担。本研究评估了具有日记功能的个人数字助理（PDA）（n = 339例患者）与纸质患者日记（n = 330例患者）相比，对干扰素β治疗方案的持续性和依从性的影响。
在这项前瞻性、非干预性的全国队列研究中，招募了最近开始皮下注射干扰素β-1b的患者，在成功完成初始剂量递增后进行为期2年的观察期。
两个研究队列中，以104周内的退出率评估的治疗持续性约为50%。在男性患者中，使用PDA的退出率比非PDA组低10%。与使用没有注射提醒功能的PDA相比，使用具有注射提醒功能的PDA在24个月内平均增加了24.5次注射对注射时间表（每隔一天）的依从性。
本研究中的持续性处于已发表的观察性MS研究范围内。此外，在男性患者中，使用PDA可能会对治疗的持续产生积极影响，并且女性和男性患者都可能从集成的提醒功能中受益。总之，提醒患者即将进行注射的电子日记可以促进对MS治疗的更好依从性。
ClinicalTrials.gov标识符：NCT00902135。
拜耳维泰有限公司。
