ULR 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, University of Lille, CHU Lille, F-59000, Lille, France.
Institut de Pharmacie, CHU Lille, F-59000, Lille, France.
Eur J Pediatr. 2021 Sep;180(9):2985-2992. doi: 10.1007/s00431-021-04041-y. Epub 2021 Apr 17.
Neonatal hyperglycaemia is frequent and requires insulin therapy. To resolve the difficulties encountered by paediatricians in stabilising glycaemia, the preparation and administration of insulin aspart were assessed and optimised. After high-performance liquid chromatography (HPLC-UV) assessment of insulin aspart preparations made according to the old protocol, a new protocol was drawn up. Dosage reliability of solutions prepared by paediatric nurses was evaluated by HPLC-UV. This new protocol was also tested in a Y-infusion situation and the need to saturate infusion tubes assessed. Wide deviations in insulin aspart concentrations were found between theoretical concentrations and preparations made according to the old protocol. Glycated insulin aspart was found in the majority of these preparations. The new protocol significantly reduced the variability of data and relative deviations around the target value. It also eliminated the formation of glycated insulin even in the case of co-infusion of parenteral nutrition and confirmed the need to saturate infusion tubes.Conclusion: The revision of the insulin therapy protocol reduced the variability of insulin concentration in preparations and avoided the administration of glycated derivatives potentially toxic for neonates. What is Known: • Insulin preparation in NICUs is a risky task because it is a two-step preparation • Diluted in dextrose, insulin aspart is unstable, with formation of potentially toxic glycated derivatives What is New: • This work proposes a new insulin therapy protocol validated by HPLC-UV for NICU allowing suppression of the formation of glycated insulin, to significantly reduce deviations from theoretical concentrations and to limit adsorption phenomena • This protocol is validated in case of co-infusion of parenteral nutrition.
新生儿高血糖症很常见,需要胰岛素治疗。为了解决儿科医生在稳定血糖方面遇到的困难,评估并优化了门冬胰岛素的配制和给药。在对根据旧方案配制的门冬胰岛素制剂进行高效液相色谱(HPLC-UV)评估后,制定了新方案。通过 HPLC-UV 评估儿科护士配制的溶液的剂量可靠性。还在 Y 型输液情况下测试了该新方案,并评估了是否需要使输液管饱和。发现根据旧方案配制的理论浓度与制剂之间的门冬胰岛素浓度存在很大偏差。在大多数这些制剂中都发现了糖化胰岛素。新方案显著降低了数据的变异性和目标值周围的相对偏差。它还消除了糖化胰岛素的形成,即使在肠外营养同时输注的情况下,也证实了需要使输液管饱和。结论:胰岛素治疗方案的修订降低了制剂中胰岛素浓度的可变性,并避免了给予可能对新生儿有毒的糖化衍生物。已知内容:•NICU 中的胰岛素制备是一项危险的任务,因为它是一个两步制备过程。•在葡萄糖中稀释后,门冬胰岛素不稳定,会形成潜在毒性的糖化衍生物。新内容:•这项工作提出了一种新的胰岛素治疗方案,通过 HPLC-UV 验证可用于 NICU,从而抑制糖化胰岛素的形成,显著降低与理论浓度的偏差,并限制吸附现象。•该方案在同时输注肠外营养的情况下得到验证。