【摘要】：目的:本文章以中國受試者為研究對(duì)象,旨在探討北京快舒爾公司無針注射賴脯胰島素的藥效及藥代動(dòng)力學(xué)參數(shù)。方法:本研究為一項(xiàng)隨機(jī)、雙盲、雙模擬、交叉試驗(yàn)。共納入18例健康受試者,每例受試者交叉接受無針注射或胰島素筆腹部皮下注射賴脯胰島素,劑量0.2 U/kg,并于注射后完成7小時(shí)正葡萄糖鉗夾試驗(yàn)。結(jié)果:與有針注射組相比,無針注射組在試驗(yàn)初始0-20min,胰島素藥-時(shí)(Ins-AUC)及葡萄糖輸注率(GIR-AUC)曲線下面積均更大(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)。無針組較有針組胰島素濃度達(dá)峰時(shí)間顯著提前53%(37.78±11.14 min vs.80.56±37.18 min,P0.001),葡萄糖輸注率(GIR)達(dá)峰時(shí)間同樣提前(73.24±29.89 min vs.116.18±51.89 min,P=0.006)。兩組間胰島素和GIR的曲線下面積(AUC)、峰濃度(Cmax)無顯著統(tǒng)計(jì)學(xué)差異。結(jié)論:相比普通胰島素筆,北京快舒爾公司無針注射器注射賴脯胰島素后藥物吸收更快、起效更迅速,更符合生理性的餐后胰島素分泌模式。
[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 鹵0.24 vs.0.10 鹵0.04 Umin L ~ (-1) P ~ (0.001) for INS-AUC,0 ~ (20) min;. 24.91 鹵15.25 vs.12.52 鹵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 鹵11.14 min vs.80.56 鹵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 鹵29.89 min vs.116.18 鹵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.
【學(xué)位授予單位】：重慶醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R969

【參考文獻(xiàn)】

相關(guān)期刊論文 前1條

1 Nasser Mikhail;;Place of technosphere inhaled insulin in treatment of diabetes[J];World Journal of Diabetes;2016年20期

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本文編號(hào)：2356561