Klasen Alison, Kessari Romain, Mercier Lionel, Valade Cyril, Grill Jacques, Desmaris Romain, Paci Angelo
Service Interdépartemental de Pharmacologie et d'Analyse du Médicament (SIPAM), Institut Gustave-Roussy, 114, rue Edouard Vaillant, 94805, Villejuif Cedex, France.
Drugs R D. 2014 Mar;14(1):13-23. doi: 10.1007/s40268-014-0037-9.
In a context of day hospital care of cancer patients, a protocol combining etoposide and carboplatin is used in paediatrics. Disposable infusion devices can be used to improve patient quality of life and to optimize nursing time. Stability data are available for carboplatin in these devices but not for etoposide. The aim of this study was to determine the stability of etoposide solutions in these devices by monitoring the changing etoposide concentration. To study the changing etoposide concentration, we investigated three different concentrations, each in two different solvents: sodium chloride (NaCl) 0.9 % and dextrose 5 %, in Intermate(®) disposable infusion devices. Quantitative analyses were performed by high-performance liquid chromatography coupled with ultraviolet (UV) detection on samples collected over a 24-h study period. The results showed that 100 mg/L etoposide solutions were stable for 24 h in NaCl 0.9 % and for 12 h in dextrose 5 %, whatever the temperature. The 400-mg/L solutions were stable for 24 h in both diluents, whatever the temperature, whereas the 600-mg/L solutions when diluted in NaCl 0.9 % and dextrose 5 % in water were stable for 8 and 6 h, respectively. We found that precipitation was the main phenomenon responsible for decreased etoposide concentrations. This study allowed us to conclude that etoposide solutions prepared in Intermate(®) infusion devices are stable for day hospital administration in paediatrics. It will also allow us to conduct a future clinical study that will focus on the medico-economic feasibility of this protocol and on the evaluation of patient and nurse satisfaction.
在癌症患者日间医院护理的背景下,儿科使用了一种将依托泊苷和顺铂联合使用的方案。一次性输液装置可用于改善患者生活质量并优化护理时间。这些装置中有顺铂的稳定性数据,但没有依托泊苷的。本研究的目的是通过监测依托泊苷浓度的变化来确定依托泊苷溶液在这些装置中的稳定性。为了研究依托泊苷浓度的变化,我们在Intermate®一次性输液装置中研究了三种不同浓度的依托泊苷,每种浓度分别在两种不同溶剂中:0.9%氯化钠(NaCl)和5%葡萄糖,通过在24小时研究期间采集的样本进行高效液相色谱结合紫外(UV)检测进行定量分析。结果表明,无论温度如何,100mg/L依托泊苷溶液在0.9%NaCl中稳定24小时,在5%葡萄糖中稳定12小时。400mg/L溶液在两种稀释剂中无论温度如何均稳定24小时,而600mg/L溶液在0.9%NaCl和5%葡萄糖水溶液中分别稳定8小时和6小时。我们发现沉淀是导致依托泊苷浓度降低的主要现象。本研究使我们得出结论,在Intermate®输液装置中制备的依托泊苷溶液在儿科日间医院给药时是稳定的。这也将使我们能够开展一项未来的临床研究,该研究将关注该方案的医学经济可行性以及患者和护士满意度的评估。