Præstmark Kezia A, Jensen Morten L, Madsen Nils B, Kildegaard Jonas, Stallknecht Bente M
Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark; Device R&D Device R&D, Novo Nordisk A/S, Hillerød, Denmark.
Medical & Science Devices , Novo Nordisk A/S , Søborg , Denmark.
BMJ Open Diabetes Res Care. 2016 Dec 15;4(1):e000266. doi: 10.1136/bmjdrc-2016-000266. eCollection 2016.
Pen needles used for subcutaneous injections have gradually become shorter, thinner and more thin walled, and thereby less robust to patient reuse. Thus, different needle sizes, alternative tip designs and needles resembling reuse were tested to explore how needle design influences ease of insertion, pain and skin trauma.
30 subjects with injection-treated type 2 diabetes and body mass index 25-35 kg/m were included in the single-blinded study. Each subject received abdominal insertions with 18 different types of needles. All needles were tested twice per subject and in random order. Penetration force (PF) through the skin, pain perception on 100 mm visual analog scale, and change in skin blood perfusion (SBP) were quantified after the insertions.
Needle diameter was positively related to PF and SBP (p<0.05) and with a positive pain trend relation. Lack of needle lubrication and small 'needle hooks' increased PF and SBP (p<0.05) but did not affect pain. Short-tip, obtuse needle grinds affected PF and SBP, but pain was only significantly affected in extreme cases. PF in skin and in polyurethane rubber were linearly related, and pain outcome was dependent of SBP increase.
The shape and design of a needle and the needle tip affect ease of insertion, pain and skin trauma. Relations are seen across different data acquisition methods and across species, enabling needle performance testing outside of clinical trials.
NCT02531776; results.
用于皮下注射的笔式针头已逐渐变得更短、更细且壁更薄，因此对患者重复使用的耐受性降低。因此，对不同的针头尺寸、替代针尖设计以及类似重复使用的针头进行了测试，以探讨针头设计如何影响插入的难易程度、疼痛和皮肤损伤。
这项单盲研究纳入了30名接受注射治疗的2型糖尿病患者，其体重指数为25 - 35 kg/m 。每位受试者在腹部使用18种不同类型的针头进行注射。所有针头对每位受试者均测试两次，且测试顺序随机。在注射后对穿透皮肤的力量（PF）、100 mm视觉模拟量表上的疼痛感知以及皮肤血流灌注（SBP）的变化进行量化。
针头直径与PF和SBP呈正相关（p<0.05），且与疼痛呈正相关趋势。缺乏针头润滑和小的“针钩”会增加PF和SBP（p<0.05），但不影响疼痛。短尖、钝头的针头研磨会影响PF和SBP，但仅在极端情况下疼痛才会受到显著影响。皮肤和聚氨酯橡胶中的PF呈线性相关，疼痛结果取决于SBP的增加。
针头的形状和设计以及针尖会影响插入的难易程度、疼痛和皮肤损伤。在不同的数据采集方法和不同物种之间都观察到了这种关系，从而能够在临床试验之外进行针头性能测试。
NCT02531776；结果
