Department of Paediatric Cardiology and Rheumatology, Medical University of Lodz, Sporna 36/50, 91-738, Lodz, Poland.
Clinic of Dermatology, Military Medical Institute, Warsaw, Poland.
Pediatr Rheumatol Online J. 2020 Aug 12;18(1):64. doi: 10.1186/s12969-020-00455-4.
Methotrexate is the most commonly used disease-modifying antirheumatic drug recommended in the treatment of juvenile idiopathic arthritis. It can be administered orally or subcutaneously, the latter method is associated with fewer side effects and higher drug bioavailability. Nevertheless, the pain associated with injection is a considerable drawback of this treatment option in the pediatric population. Currently, there are two single-use subcutaneous injection devices available: the prefilled syringe and the prefilled pen. This prospective, two-sequence crossover study aimed to compare ease of use, frequency of therapy side effects, injection-site pain and parent/patient preference of those methotrexate parenteral delivery systems.
Twenty-three patients with juvenile idiopathic arthritis, already treated with subcutaneous methotrexate in the form of prefilled syringe in the period October 2018 - April 2019 completed a questionnaire evaluating their experience with this device. Subsequently, children received a one-month supply of pen autoinjector and completed the same questionnaire, regarding their experience with the new methotrexate delivery system. If the patient was not performing the injections himself the questionnaires were completed by the caregiver administrating MTX. The results obtained in both questionnaires were compared using the Wilcoxon matched-pairs signed-rank test.
82,6% patients and their caregivers voted for the prefilled pen as their preferred method of subcutaneous methotrexate administration. Moreover, the injection with the prefilled pen was reported as less painful in comparison to the prefilled syringe (p < 0.01). Side effects of methotrexate were less pronounced after the prefilled pen treatment, this difference was most prominent regarding gastrointestinal adverse events associated with the injection (p < 0.01).
Administration of methotrexate using the pen device is a promising way of subcutaneous methotrexate delivery in children with juvenile idiopathic arthritis, as the injection is less painful and associated with fewer side effects.
甲氨蝶呤是治疗幼年特发性关节炎(JIA)最常推荐使用的疾病修饰抗风湿药物。它可以口服或皮下给药,后者的副作用更少,药物生物利用度更高。然而,注射带来的疼痛是儿科人群选择这种治疗方案的一个相当大的缺点。目前,有两种即用型皮下注射装置可供选择:预充注射器和预充笔。这项前瞻性、双序列交叉研究旨在比较这两种甲氨蝶呤皮下给药系统的易用性、治疗副作用的频率、注射部位疼痛和家长/患者的偏好。
23 名 JIA 患者已经接受了预充注射器皮下注射甲氨蝶呤治疗,于 2018 年 10 月至 2019 年 4 月期间完成了一份评估他们使用该设备经验的问卷。随后,孩子们接受了一个月的笔式自动注射器供应,并完成了同一份问卷,评估他们对新的甲氨蝶呤给药系统的体验。如果患者自己不进行注射,则由管理 MTX 的护理人员填写问卷。使用 Wilcoxon 配对符号秩检验比较两份问卷的结果。
82.6%的患者及其护理人员投票赞成预充笔作为他们首选的皮下甲氨蝶呤给药方法。此外,与预充注射器相比,预充笔注射的疼痛感更轻(p<0.01)。与预充笔治疗相比,甲氨蝶呤的副作用更不明显,这在与注射相关的胃肠道不良事件方面差异最为显著(p<0.01)。
在儿童 JIA 患者中,使用笔式装置进行甲氨蝶呤给药是一种很有前途的皮下甲氨蝶呤给药方式,因为注射的疼痛感更低,副作用更少。