Heise T, Nosek L, Dellweg S, Zijlstra E, Præstmark K A, Kildegaard J, Nielsen G, Sparre T
Profil, Neuss, Germany.
Diabetes Obes Metab. 2014 Oct;16(10):971-6. doi: 10.1111/dom.12304. Epub 2014 May 11.
The aim of this study was to assess pain associated with subcutaneous injection into the abdomen and thigh of different combinations of injection speeds and volumes.
The study was a single-centre, one-visit, double-blinded, randomized controlled trial in 82 adults with type 1 or type 2 diabetes receiving daily injections of insulin or glucagon-like peptide-1 (GLP-1) agonists. Participants received 17 subcutaneous injections (12 in abdomen, 5 in thigh) of saline at different injection speeds (150, 300 and 450 µl/s), with different volumes (400, 800, 1200 and 1600 µl), and two needle insertions without any injection. Pain was evaluated on a 100-mm visual analogue scale (VAS) (0 mm no pain, 100 mm worst pain) and on a yes/no scale for pain acceptability.
Injection speed had no impact on injection pain (p = 0.833). Injection of larger volumes caused significantly more pain [VAS least square mean differences 1600 vs. 400 µl, 7 · 2 mm (95% confidence interval - CI; 4.6-9.7; p < 0.0001); 1600 vs. 800 µl, 7.2 mm (4.4-10.0; p < 0.0001); 1200 vs. 400 µl, 3.5 mm (0.4-6.6; p = 0.025) and 1200 vs. 800 µl, 3.6 mm (0.4-6.7; p = 0.027)]. Significantly more pain occurred in the thigh versus the abdomen [9.0 mm (6.7-11.3; p < 0.0001)].
Injection speed had no effect on injection pain, whereas higher injection volumes caused more pain. The results of this study may be of value for guiding patients to use the appropriate injection site and technique to reduce their injection pain. Furthermore, these findings may have important implications for the development of new injection devices and drug formulations for clinical practice.
本研究旨在评估不同注射速度和体积组合下,腹部和大腿皮下注射所产生的疼痛。
本研究为单中心、单次就诊、双盲、随机对照试验,纳入82例1型或2型糖尿病成年患者,这些患者每日注射胰岛素或胰高血糖素样肽-1(GLP-1)激动剂。参与者接受17次皮下注射(12次注射于腹部,5次注射于大腿),注射不同速度(150、300和450 μl/s)、不同体积(400、800、1200和1600 μl)的生理盐水,并进行两次不注射的进针操作。疼痛通过100毫米视觉模拟量表(VAS)(0毫米表示无疼痛,100毫米表示最剧烈疼痛)以及疼痛可接受性的是/否量表进行评估。
注射速度对注射疼痛无影响(p = 0.833)。注射较大体积时疼痛明显更剧烈[VAS最小二乘均值差异:1600 μl与400 μl相比,7.2毫米(95%置信区间 - CI;4.6 - 9.7;p < 0.0001);1600 μl与800 μl相比,7.2毫米(4.4 - 10.0;p < 0.0001);1200 μl与400 μl相比,3.5毫米(0.4 - 6.6;p = 0.025)以及1200 μl与800 μl相比,3.6毫米(0.4 - 6.7;p = 0.027)]。大腿注射时的疼痛明显多于腹部[9.0毫米(6.7 - 11.3;p < 0.0001)]。
注射速度对注射疼痛无影响,而较高的注射体积会导致更多疼痛。本研究结果可能有助于指导患者采用合适的注射部位和技术以减轻注射疼痛。此外,这些发现可能对临床实践中新型注射装置和药物制剂的研发具有重要意义。