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User assessment of Norditropin NordiFlex?,a new prefilled growth hormone pen:a Phase IV multicenter prospective study

机译:新型预填充生长激素笔Norditropin NordiFlex?的用户评估:一项IV期多中心前瞻性研究

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Background/aim: In growth disorders, ensuring long-term growth hormone therapy (GHT) remains a challenge that might compromise the clinical outcome. Consequently, strategies aiming at alleviating the burden of daily injection might improve the treatment benefit. The study reported here was performed to assess the ease of use of Norditropin NordiFlex? (Novo Nordisk, Princeton, NJ, USA) compared with that of the devices previously used in children treated with GHT with recombinant somatropin.Methods: This Phase IV prospective, multicenter, open-label study was conducted in France. All patients received Norditropin NordiFlex for 6 weeks. Oral questionnaires were administered by the physician to the patients and/or the parents at inclusion and at the final visit.Results: This study included 103 patients aged between 6 and 17 years. The patients assessed Norditropin NordiFlex as significantly easier to use than their previous device (median value = 7.5, P < 0.001). Almost three-quarters of patients (64.4%) preferred Norditropin NordiFlex to their previous device. Among physicians and nurses, 73% assessed Norditropin NordiFlex training as "very easy" and 26% as "easy." Norditropin NordiFlex improved patient autonomy, with 41% of patients able to self-inject the treatment.Conclusion: This study has shown that Norditropin NordiFlex is reliable, safe, and easy to use and most study patients preferred it to their previous device. These characteristics may improve the adherence to GHT.
机译:背景/目的:在生长障碍中,确保长期生长激素治疗(GHT)仍然是一项挑战,可能会损害临床结果。因此,旨在减轻每日注射负担的策略可能会改善治疗效果。此处报道的研究旨在评估降钙素NordiFlex®的易用性。 (Novo Nordisk,Princeton,NJ,USA)与以前用重组生长激素进行GHT治疗的儿童中使用的设备进行了比较。方法:该IV期前瞻性,多中心,开放标签研究在法国进行。所有患者均接受Norditropin NordiFlex治疗6周。在入组时和最后访视时,医生向患者和/或父母进行了口服问卷调查。结果:本研究包括103名年龄在6至17岁之间的患者。患者评估了Norditropin NordiFlex比以前的设备使用起来容易得多(中位数= 7.5,P <0.001)。近四分之三的患者(64.4%)较之以前的设备更喜欢使用Norditropin NordiFlex。在医师和护士中,有73%的人将Norditropin NordiFlex培训评估为“非常容易”,而将26%的评估为“容易”。 Norditropin NordiFlex改善了患者的自主性,有41%的患者能够自行注射治疗。结论:这项研究表明Norditropin NordiFlex是可靠,安全且易于使用的,并且大多数研究患者均较以前的设备偏爱它。这些特性可以改善对GHT的依从性。

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