正常血糖-高胰岛素钳夹技术在胰岛素制剂药物代谢动力学研究中的应用进展_West China Medical Journal

Authors：

谭惠文 ,  余叶蓉 , 李秀钧

四川大学华西医院内分泌科（成都 610041）;

Corresponding author：

余叶蓉, Email: yerongyu@scu.edu.cn

Keywords：

正常血糖-高胰岛素钳夹技术; 胰岛素制剂; 药物代谢动力学; 药物效应动力学

DOI：

10.7507/1002-0179.201603278

Video：

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正常血糖-高胰岛素钳夹技术是评价胰岛素敏感性的金标准技术。葡萄糖钳夹技术在糖尿病和胰岛素抵抗相关疾病的研究中具有独特的价值。近年来，随着胰岛素制剂及其类似物的迅速发展，该技术在其药物代谢动力学和药物效应动力学研究中的应用日益广泛。该文就正常血糖-高胰岛素钳夹技术在胰岛素制剂的药物代谢动力学及药物效应动力学研究中的发展历程和应用进展作一简要综述。

Citation： 谭惠文, 余叶蓉, 李秀钧. 正常血糖-高胰岛素钳夹技术在胰岛素制剂药物代谢动力学研究中的应用进展. West China Medical Journal, 2017, 32(11): 1801-1804. doi: 10.7507/1002-0179.201603278 Copy

1.	Polonsky KS. The past 200 years in diabetes. N Engl J Med. 2012, 367: 1332-1340.
2.	Heise T, Zijlstra E, Nosek L, et al. Euglycaemic glucose clamp: what it can and cannot do, and how to do it. Diabetes Obes Metab, 2016, 18(10): 962-972.
3.	Andres R, Baltzan MA, Cader G, et al. Effect of insulin on carbohydrate metabolism and on potassium in the forearm of man. J Clin Invest, 1962, 41(1): 108-115.
4.	DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol, 1979, 237(3): E214-E223.
5.	邓尚平. 胰岛素抵抗的临床测定方法和评价//李秀钧. 代谢综合征. 2 版. 北京: 人民卫生出版社, 2007: 101-109.
6.	董立厚, 宋海峰. 高胰岛素-正葡萄糖钳夹技术的研究进展. 中国新药杂志, 2007, 16(19): 1561-1564.
7.	Huang M, Joseph JW. Assessment of the metabolic pathways associated with glucose-stimulated biphasic insulin secretion. Endocrinology, 2014, 155(5): 1653-1666.
8.	Donga E, Dekkers OM, Corssmit EP, et al. Insulin resistance in patients with type 1 diabetes assessed by glucose clamp studies: systematic review and meta-analysis. Eur J Endocrinol. 2015, 173(1): 101-109.
9.	赵维纲, 袁涛, 付勇, 等. 正常血糖高胰岛素钳夹法观察罗格列酮治疗 2 型糖尿病胰岛素抵抗的疗效. 中华临床营养杂志, 2009, 17(3): 133-135.
10.	Rave K, Nosek L, Heinemann L, et al. Time-action profile of the long-acting insulin analogue insulin glargine in comparison to NPH insulin in Japanese volunteers. Diabetes Metab, 2003, 29(4 Pt 1): 430-431.
11.	赵维纲, 王姮, 李玉秀, 等. 胰岛素口腔喷雾剂在正常人口腔粘膜的吸收和生物学效应. 中华内分泌代谢杂志, 2003, 19(4): 275-278.
12.	Becker RH, Frick AD, Burger F, et al. A comparison of the steady-state pharmacokinetics and pharmacodynamics of a novel rapid-acting insulin analog, insulin glulisine, and regular human insulin in healthy volunteers using the euglycemic clamp technique. Exp Clin Endocrinol Diabetes, 2005, 113(5): 292-297.
13.	Scholtz HE, Pretorius SG, Wessels DH, et al. Pharmacokinetic and glucodynamic variability: assessment of insulin glargine, NPH insulin and insulin ultralente in healthy volunteers using a euglycaemic clamp technique. Diabetologia, 2005, 48(10): 1988-1995.
14.	Hompesch M, Ocheltree SM, Wondmagegnehu ET, et al. Pharmacokinetics and pharmacodynamics of insulin lispro protamine suspension compared with insulin glargine and insulin detemir in type 2 diabetes. Curr Med Res Opin, 2009, 25(11): 2679-2687.
15.	Benesch C, Heise T, Klein O, et al. How to assess the quality of glucose clamps? Evaluation of clamps performed with ClampArt, a novel automated clamp device. J Diabetes Sci Technol, 2015, 9(4): 792-800.
16.	Cahn A, Miccoli R, Dardano A, et al. New forms of insulin and insulin therapies for the treatment of type 2 diabetes. Lancet Diabetes Endocrinol, 2015, 3(8): 638-652.
17.	De Souza AL, Batista GA, Alegre SM. Assessment of insulin sensitivity by the hyperinsulinemic euglycemic clamp: comparison with the spectral analysis of photoplethysmography. J Diabetes Complications, 2017, 31(1): 128-133.
18.	廖志红, 廖瑛, 李延兵, 等. 吸入胰岛素粉雾剂对 1 型糖尿病患者药代学的一期临床研究. 中华医学杂志, 2006, 86(28): 2005-2007.
19.	程时武, 陆菊明, 潘长玉, 等. 重组甘精胰岛素注射液的人体药代动力学、药效学及生物等效性研究. 中国糖尿病杂志, 2010, 18(5): 387-391.
20.	谭惠文, 王椿, 刘瑶霞, 等. 短效重组人胰岛素在人体内的药动学及药效学研究. 华西药学杂志, 2011, 26(5): 430-434.
21.	Li J, Wang Y, Han L, et al. Time-action profile of an oral enteric insulin formulation in healthy Chinese volunteers. Clin Ther, 2012, 34(12):2333-2338.
22.	Koehler G, Treiber G, Wutte A, et al. Pharmacodynamics of the long-acting insulin analogues detemir and glargine following single-doses and under steady-state conditions in patients with type 1 diabetes. Diabetes Obes Metab, 2014, 16 (1): 57-62.
23.	Heise T, Hövelmann U, Nosek L, et al. Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol, 2015, 11(8):1193-1201.
24.	Linnebjerg H, Lam EC, Zhang X, et al. Duration of action of two insulin glargine products, LY2963016 insulin glargine and Lantus insulin glargine, in subjects with type 1 diabetes mellitus. Diabetes Obes Metab, 2017, 19(1): 33-39.
25.	Kapitza C, Nowotny I, Lehmann A, et al. Similar pharmacokinetics and pharmacodynamics of rapid-acting insulin lispro products SAR342434 and US- and EU-approved Humalog in subjects with type 1 diabetes. Diabetes Obes Metab, 2017, 19(5): 622-627.
26.	Setji TL, Hong BD, Feinglos MN. Technosphere insulin: inhaled prandial insulin. Expert Opin Biol Ther, 2016, 16(1): 111-117.

1. Polonsky KS. The past 200 years in diabetes. N Engl J Med. 2012, 367: 1332-1340.
2. Heise T, Zijlstra E, Nosek L, et al. Euglycaemic glucose clamp: what it can and cannot do, and how to do it. Diabetes Obes Metab, 2016, 18(10): 962-972.
3. Andres R, Baltzan MA, Cader G, et al. Effect of insulin on carbohydrate metabolism and on potassium in the forearm of man. J Clin Invest, 1962, 41(1): 108-115.
4. DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol, 1979, 237(3): E214-E223.
5. 邓尚平. 胰岛素抵抗的临床测定方法和评价//李秀钧. 代谢综合征. 2 版. 北京: 人民卫生出版社, 2007: 101-109.
6. 董立厚, 宋海峰. 高胰岛素-正葡萄糖钳夹技术的研究进展. 中国新药杂志, 2007, 16(19): 1561-1564.
7. Huang M, Joseph JW. Assessment of the metabolic pathways associated with glucose-stimulated biphasic insulin secretion. Endocrinology, 2014, 155(5): 1653-1666.
8. Donga E, Dekkers OM, Corssmit EP, et al. Insulin resistance in patients with type 1 diabetes assessed by glucose clamp studies: systematic review and meta-analysis. Eur J Endocrinol. 2015, 173(1): 101-109.
9. 赵维纲, 袁涛, 付勇, 等. 正常血糖高胰岛素钳夹法观察罗格列酮治疗 2 型糖尿病胰岛素抵抗的疗效. 中华临床营养杂志, 2009, 17(3): 133-135.
10. Rave K, Nosek L, Heinemann L, et al. Time-action profile of the long-acting insulin analogue insulin glargine in comparison to NPH insulin in Japanese volunteers. Diabetes Metab, 2003, 29(4 Pt 1): 430-431.
11. 赵维纲, 王姮, 李玉秀, 等. 胰岛素口腔喷雾剂在正常人口腔粘膜的吸收和生物学效应. 中华内分泌代谢杂志, 2003, 19(4): 275-278.
12. Becker RH, Frick AD, Burger F, et al. A comparison of the steady-state pharmacokinetics and pharmacodynamics of a novel rapid-acting insulin analog, insulin glulisine, and regular human insulin in healthy volunteers using the euglycemic clamp technique. Exp Clin Endocrinol Diabetes, 2005, 113(5): 292-297.
13. Scholtz HE, Pretorius SG, Wessels DH, et al. Pharmacokinetic and glucodynamic variability: assessment of insulin glargine, NPH insulin and insulin ultralente in healthy volunteers using a euglycaemic clamp technique. Diabetologia, 2005, 48(10): 1988-1995.
14. Hompesch M, Ocheltree SM, Wondmagegnehu ET, et al. Pharmacokinetics and pharmacodynamics of insulin lispro protamine suspension compared with insulin glargine and insulin detemir in type 2 diabetes. Curr Med Res Opin, 2009, 25(11): 2679-2687.
15. Benesch C, Heise T, Klein O, et al. How to assess the quality of glucose clamps? Evaluation of clamps performed with ClampArt, a novel automated clamp device. J Diabetes Sci Technol, 2015, 9(4): 792-800.
16. Cahn A, Miccoli R, Dardano A, et al. New forms of insulin and insulin therapies for the treatment of type 2 diabetes. Lancet Diabetes Endocrinol, 2015, 3(8): 638-652.
17. De Souza AL, Batista GA, Alegre SM. Assessment of insulin sensitivity by the hyperinsulinemic euglycemic clamp: comparison with the spectral analysis of photoplethysmography. J Diabetes Complications, 2017, 31(1): 128-133.
18. 廖志红, 廖瑛, 李延兵, 等. 吸入胰岛素粉雾剂对 1 型糖尿病患者药代学的一期临床研究. 中华医学杂志, 2006, 86(28): 2005-2007.
19. 程时武, 陆菊明, 潘长玉, 等. 重组甘精胰岛素注射液的人体药代动力学、药效学及生物等效性研究. 中国糖尿病杂志, 2010, 18(5): 387-391.
20. 谭惠文, 王椿, 刘瑶霞, 等. 短效重组人胰岛素在人体内的药动学及药效学研究. 华西药学杂志, 2011, 26(5): 430-434.
21. Li J, Wang Y, Han L, et al. Time-action profile of an oral enteric insulin formulation in healthy Chinese volunteers. Clin Ther, 2012, 34(12):2333-2338.
22. Koehler G, Treiber G, Wutte A, et al. Pharmacodynamics of the long-acting insulin analogues detemir and glargine following single-doses and under steady-state conditions in patients with type 1 diabetes. Diabetes Obes Metab, 2014, 16 (1): 57-62.
23. Heise T, Hövelmann U, Nosek L, et al. Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol, 2015, 11(8):1193-1201.
24. Linnebjerg H, Lam EC, Zhang X, et al. Duration of action of two insulin glargine products, LY2963016 insulin glargine and Lantus insulin glargine, in subjects with type 1 diabetes mellitus. Diabetes Obes Metab, 2017, 19(1): 33-39.
25. Kapitza C, Nowotny I, Lehmann A, et al. Similar pharmacokinetics and pharmacodynamics of rapid-acting insulin lispro products SAR342434 and US- and EU-approved Humalog in subjects with type 1 diabetes. Diabetes Obes Metab, 2017, 19(5): 622-627.
26. Setji TL, Hong BD, Feinglos MN. Technosphere insulin: inhaled prandial insulin. Expert Opin Biol Ther, 2016, 16(1): 111-117.

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正常血糖-高胰岛素钳夹技术在胰岛素制剂药物代谢动力学研究中的应用进展

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