无针注射器和胰岛素笔皮下注射赖脯胰岛素的药代动力学—药效学研究：一项随机交叉试验

发布时间：2018-11-25 15:16

【摘要】：目的:本文章以中国受试者为研究对象,旨在探讨北京快舒尔公司无针注射赖脯胰岛素的药效及药代动力学参数。方法:本研究为一项随机、双盲、双模拟、交叉试验。共纳入18例健康受试者,每例受试者交叉接受无针注射或胰岛素笔腹部皮下注射赖脯胰岛素,剂量0.2 U/kg,并于注射后完成7小时正葡萄糖钳夹试验。结果:与有针注射组相比,无针注射组在试验初始0-20min,胰岛素药-时(Ins-AUC)及葡萄糖输注率(GIR-AUC)曲线下面积均更大(0.36±0.24 vs.0.10±0.04 UminL-1,P0.001 for INS-AUC,0 20 min;24.91±15.25 vs.12.52±7.60 mgkg-1,P0.001 for GIR-AUC,0-20min)。无针组较有针组胰岛素浓度达峰时间显著提前53%(37.78±11.14 min vs.80.56±37.18 min,P0.001),葡萄糖输注率(GIR)达峰时间同样提前(73.24±29.89 min vs.116.18±51.89 min,P=0.006)。两组间胰岛素和GIR的曲线下面积(AUC)、峰浓度(Cmax)无显著统计学差异。结论:相比普通胰岛素笔,北京快舒尔公司无针注射器注射赖脯胰岛素后药物吸收更快、起效更迅速,更符合生理性的餐后胰岛素分泌模式。
[Abstract]:Objective: to study the pharmacodynamics and pharmacokinetic parameters of proline without needle injection in Beijing Fesuer Company. Methods: this study was a randomized, double-blind, double-simulation, cross-test. A total of 18 healthy subjects were enrolled in this study. Each patient was cross-administered with proline insulin without needle injection or intraabdominal subcutaneous injection with insulin pen at a dose of 0.2 U / kg, and the 7-hour glucose clamp test was completed. Results: compared with the needle injection group, the needle free injection group was at the beginning of the experiment 0-20 minutes. The area under the curve of insulin dose-hour (Ins-AUC) and glucose infusion rate (GIR-AUC) was larger (0.36 卤0.24 vs.0.10 卤0.04 Umin L ~ (-1) P ~ (0.001) for INS-AUC,0 ~ (20) min;. 24.91 卤15.25 vs.12.52 卤7.60 mg?kg-1,P0.001 for GIR-AUC,0-20min). The peak time of insulin concentration in the acupuncture group was significantly earlier by 53% (37.78 卤11.14 min vs.80.56 卤37.18 min,P0.001) than that in the needle group, and the peak time of glucose infusion rate (GIR) was also advanced (73.24 卤29.89 min vs.116.18 卤51.89 min,). P0. 006). There was no significant difference in (AUC), peak concentration (Cmax) between the two groups under the curve of insulin and GIR. Conclusion: compared with the ordinary insulin pen, the drug absorption, effect and physiological pattern of insulin secretion are faster and faster after injection of proline insulin without needle syringe in Beijing fast syringe.
【学位授予单位】：重庆医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R969

【参考文献】