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一项探索与皮下注射相比,InsuJet 给药门冬胰岛素在 1 型糖尿病患者中的耐受性和器械偏好的初步研究。

A pilot study to examine the tolerability and device preference in type 1 diabetes of insulin aspart administered by InsuJet compared with subcutaneous injection.

作者信息

Reutens Anne T, Balkau Beverley, Cohen Neale

机构信息

1 Baker IDI Heart and Diabetes Institute , Melbourne, Victoria, Australia .

出版信息

Diabetes Technol Ther. 2014 Apr;16(4):235-40. doi: 10.1089/dia.2013.0250. Epub 2013 Nov 28.

Abstract

BACKGROUND

Jet injectors allow needle-free insulin delivery. The study objective was to compare the tolerability and device preference of subcutaneous insulin aspart delivery by jet injector (InsuJet™; European Pharma Group, Schiphol-Rijk, The Netherlands) with pen injection in an open-label, randomized, crossover pilot study.

SUBJECTS AND METHODS

Ten participants with type 1 diabetes underwent two meal tolerance tests 1 week apart. Plasma glucose and serum insulin levels were sampled from 10 min preceding to 240 min after insulin aspart administration by InsuJet or FlexPen(®) (Novo Nordisk Pharmaceuticals Pty. Ltd., Baulkham Hills, NSW, Australia). Insulin dose was calculated using participants' insulin-to-carbohydrate ratios. Immediately after insulin administration, participants drank 500 mL of Ensure(®) (Abbott Australasia Pty. Ltd., Botany, NSW, Australia) (providing 2,240 kJ of energy, 18.6 g of protein, 96 g of carbohydrate, and 3 g of fat).

RESULTS

In this small pilot study, the devices were similar in glucose excursion (median [quartile 1, quartile 3], InsuJet vs. FlexPen, 9.4 [4.8, 12.8] vs. 8.1 [5.4, 10.6] mmol/L; P=0.43), in the area under the glucose concentration-time curve for 0-240 min corrected for baseline glucose level (InsuJet vs. FlexPen, 1,230 [623, 2,012] vs. 1,175 [91, 1,774] mmol · min/L; P=0.4), and in insulin absorption over the 240-min period. Devices were similar for participant preference and relative injection pain.

CONCLUSIONS

Subcutaneous jet injection of aspart insulin was well tolerated.

摘要

背景

喷射注射器可实现无针胰岛素注射。本研究的目的是在一项开放标签、随机、交叉试点研究中,比较喷射注射器(InsuJet™;欧洲制药集团,荷兰史基浦 - 里耶克)与笔式注射皮下注射门冬胰岛素的耐受性和设备偏好。

受试者与方法

10名1型糖尿病患者,间隔1周进行两次进餐耐量试验。在通过InsuJet或优伴笔(FlexPen®)(诺和诺德制药私人有限公司,澳大利亚新南威尔士州鲍尔克姆山)给予门冬胰岛素前10分钟至给药后240分钟期间采集血浆葡萄糖和血清胰岛素水平样本。胰岛素剂量根据参与者的胰岛素 - 碳水化合物比例计算。胰岛素给药后,参与者立即饮用500毫升安素(Ensure®)(雅培澳大利亚私人有限公司,澳大利亚新南威尔士州博特尼)(提供2240千焦能量、18.6克蛋白质、96克碳水化合物和3克脂肪)。

结果

在这项小型试点研究中,两种设备在血糖波动方面相似(中位数[四分位数1,四分位数3],InsuJet与优伴笔,9.4[4.8,12.8]与8.1[5.4,10.6]毫摩尔/升;P = 0.43),在根据基线血糖水平校正的0 - 240分钟葡萄糖浓度 - 时间曲线下面积方面相似(InsuJet与优伴笔,1230[623,2012]与1175[91,1774]毫摩尔·分钟/升;P = 0.4),以及在240分钟期间的胰岛素吸收方面相似。两种设备在参与者偏好和相对注射疼痛方面相似。

结论

皮下喷射注射门冬胰岛素耐受性良好。

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