正常血糖-高胰島素鉗夾技術在胰島素制劑藥物代謝動力學研究中的應用進展_West China Medical Journal

Authors：

譚惠文 ,  余葉蓉 , 李秀鈞

四川大學華西醫院內分泌科（成都 610041）;

Corresponding?author：

余葉蓉, Email: yerongyu@scu.edu.cn

Keywords：

正常血糖-高胰島素鉗夾技術; 胰島素制劑; 藥物代謝動力學; 藥物效應動力學

DOI：

10.7507/1002-0179.201603278

Video：

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正常血糖-高胰島素鉗夾技術是評價胰島素敏感性的金標準技術。葡萄糖鉗夾技術在糖尿病和胰島素抵抗相關疾病的研究中具有獨特的價值。近年來，隨著胰島素制劑及其類似物的迅速發展，該技術在其藥物代謝動力學和藥物效應動力學研究中的應用日益廣泛。該文就正常血糖-高胰島素鉗夾技術在胰島素制劑的藥物代謝動力學及藥物效應動力學研究中的發展歷程和應用進展作一簡要綜述。

Citation： 譚惠文, 余葉蓉, 李秀鈞. 正常血糖-高胰島素鉗夾技術在胰島素制劑藥物代謝動力學研究中的應用進展. 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.	鄧尚平. 胰島素抵抗的臨床測定方法和評價//李秀鈞. 代謝綜合征. 2 版. 北京: 人民衛生出版社, 2007: 101-109.
6.	董立厚, 宋海峰. 高胰島素-正葡萄糖鉗夾技術的研究進展. 中國新藥雜志, 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.	趙維綱, 袁濤, 付勇, 等. 正常血糖高胰島素鉗夾法觀察羅格列酮治療 2 型糖尿病胰島素抵抗的療效. 中華臨床營養雜志, 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.	趙維綱, 王姮, 李玉秀, 等. 胰島素口腔噴霧劑在正常人口腔粘膜的吸收和生物學效應. 中華內分泌代謝雜志, 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.	廖志紅, 廖瑛, 李延兵, 等. 吸入胰島素粉霧劑對 1 型糖尿病患者藥代學的一期臨床研究. 中華醫學雜志, 2006, 86(28): 2005-2007.
19.	程時武, 陸菊明, 潘長玉, 等. 重組甘精胰島素注射液的人體藥代動力學、藥效學及生物等效性研究. 中國糖尿病雜志, 2010, 18(5): 387-391.
20.	譚惠文, 王椿, 劉瑤霞, 等. 短效重組人胰島素在人體內的藥動學及藥效學研究. 華西藥學雜志, 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, H?velmann 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. 鄧尚平. 胰島素抵抗的臨床測定方法和評價//李秀鈞. 代謝綜合征. 2 版. 北京: 人民衛生出版社, 2007: 101-109.
6. 董立厚, 宋海峰. 高胰島素-正葡萄糖鉗夾技術的研究進展. 中國新藥雜志, 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. 趙維綱, 袁濤, 付勇, 等. 正常血糖高胰島素鉗夾法觀察羅格列酮治療 2 型糖尿病胰島素抵抗的療效. 中華臨床營養雜志, 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. 趙維綱, 王姮, 李玉秀, 等. 胰島素口腔噴霧劑在正常人口腔粘膜的吸收和生物學效應. 中華內分泌代謝雜志, 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. 廖志紅, 廖瑛, 李延兵, 等. 吸入胰島素粉霧劑對 1 型糖尿病患者藥代學的一期臨床研究. 中華醫學雜志, 2006, 86(28): 2005-2007.
19. 程時武, 陸菊明, 潘長玉, 等. 重組甘精胰島素注射液的人體藥代動力學、藥效學及生物等效性研究. 中國糖尿病雜志, 2010, 18(5): 387-391.
20. 譚惠文, 王椿, 劉瑤霞, 等. 短效重組人胰島素在人體內的藥動學及藥效學研究. 華西藥學雜志, 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, H?velmann 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-高胰島素鉗夾技術在胰島素制劑藥物代謝動力學研究中的應用進展

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