高温对笔芯中基础胰岛素稳定性的影响：一项随机对照、交叉、等效性试验。
The Effect of high temperature on the stability of basal insulin in a pen: a randomized controlled, crossover, equivalence trial.
机构信息
Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Department of Biochemistry, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
出版信息
BMJ Open Diabetes Res Care. 2022 Dec;10(6). doi: 10.1136/bmjdrc-2022-003105.
INTRODUCTION
Insulin is an essential medicine in the management of diabetes. When stored at high temperatures(HTs), its efficacy could rapidly decline. Therefore, appropriate storage of in-use insulin is necessary to achieve its maximum therapeutic effects. However, the ambient temperature in tropical countries is normally relatively high. This study aimed to compare the efficacies of basal insulin in a pen previously kept at 37°C for 21 days and basal insulin in a refrigerated pen (2°C-8°C). Continuous glucose monitoring (CGM) was used to evaluate daily mean glucose levels (MGLs).
RESEARCH DESIGN AND METHODS
This randomized controlled, crossover, equivalence trial recruited adults with type 2 diabetes mellitus and glycated hemoglobin levels <8% who had used insulin glargine for >3 months. Subjects were randomized for sequential use of refrigerated basal insulin followed by basal insulin kept at HT, with a 2-week washout between phases. The HT insulin pens were stored in a 37°C incubator for 21 days before use, while the refrigerated insulin pens were stored at 2°C-8°C. Study patients received 7-day CGM. The primary outcome was the difference in the groups' MGLs. The secondary outcome parameters were glucose variability represented by the standard deviation (SD), mean amplitude of glycemic excursion (MAGE), and percentage of time in range (TIR). The remaining quantity of insulin was evaluated by ultrahigh-performance liquid chromatography (UHPLC) assay.
RESULTS
Forty patients completed the study. The MGLwas 158.7±30.5 mg/dL and 157.0±40.9 mg/dL in the HT and refrigerated insulin pen groups, respectively (p0.72). The groups had no significant differences in MAGE, SD, percentage of TIR, carryover period, or treatment effects (all p>0.05). There was also no significant difference in the remaining quantity of insulin evaluated by UHPLC (p=0.97).
CONCLUSIONS
HT basal insulin pens retain their potency and have biological activity comparable to that of refrigerated pens. TCTR20210611002.
简介
胰岛素是糖尿病管理中必不可少的药物。当存放在高温下时，其疗效会迅速下降。因此，为了达到最大的治疗效果，有必要对正在使用的胰岛素进行适当的储存。然而，热带国家的环境温度通常相对较高。本研究旨在比较在 37°C 下保存 21 天的笔芯胰岛素和冷藏笔芯胰岛素（2°C-8°C）的基础胰岛素的疗效。连续血糖监测（CGM）用于评估每日平均血糖水平（MGL）。
研究设计和方法
这是一项随机对照、交叉、等效性试验，招募了使用甘精胰岛素超过 3 个月且糖化血红蛋白水平<8%的 2 型糖尿病成年患者。受试者随机顺序使用冷藏基础胰岛素，然后使用高温保存的基础胰岛素，两阶段之间有 2 周的洗脱期。在使用前，高温胰岛素笔芯在 37°C 培养箱中保存 21 天，而冷藏胰岛素笔芯则在 2°C-8°C 下保存。研究患者接受了 7 天的 CGM。主要结局是两组 MGL 的差异。次要结局参数为血糖变异性，以标准差（SD）、平均血糖波动幅度（MAGE）和血糖控制达标时间（TIR）百分比表示。胰岛素剩余量通过超高效液相色谱（UHPLC）测定。
结果
40 名患者完成了研究。高温组和冷藏组的 MGL 分别为 158.7±30.5mg/dL 和 157.0±40.9mg/dL（p>0.72）。两组间 MAGE、SD、TIR 百分比、残留期和治疗效果均无显著差异（均 p>0.05）。UHPLC 评估的胰岛素剩余量也无显著差异（p=0.97）。
结论
高温胰岛素笔芯保留其效力，具有与冷藏笔芯相当的生物活性。TCTR20210611002。
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