Castillo M, Nemery A, Verdin E, Lefebvre P J, Luyckx A S
Eur J Clin Pharmacol. 1983;25(6):767-71. doi: 10.1007/BF00542517.
Sixteen hospitalized insulin requiring diabetics treated with a single daily subcutaneous injection were randomly allocated either to a mixture of porcine Actrapid + Lente MC or a mixture of Regular + NPH-Biosynthetic human insulin (Study 1). In Study 2, 10 patients receiving two daily insulin injections were treated at random with either porcine Actrapid + Monotard, or Actrapid + Monotard-Semisynthetic human insulin or Regular + NPH--Biosynthetic human insulin. Once an optimal insulin regimen was obtained, circadian blood glucose and plasma free insulin profiles (7-9 time points) were determined with the two (Study 1) or three (Study 2) insulin preparations, keeping the doses of insulin constant. In Study 1 no significant difference in blood glucose (BG) or plasma free insulin (FIRI) profiles was observed. The mean daily blood glucose, the mean amplitude of glycaemic excursions (MAGE), the index of blood glucose control (M-value of Schlichtkrull), as well as the postbreakfast increases in blood glucose and mean free IRI, were similar with both types of insulin. In Study 2, BG and FIRI profiles were also similar, except for a significantly lower (p less than 0.02) BG at 8.30 p.m. with both human insulins. No significant differences were found in free IRI at that time. Mean BG, M index, MAGE and mean FIRI were similar but the postbreakfast increase was significantly smaller with SHI. In conclusion, the pharmacokinetics of animal monocomponent, semisynthetic and biosynthetic human insulin appear similar, but evening BG control was better with both types of human insulins given twice daily.
16名住院的需要胰岛素治疗的糖尿病患者,采用每日一次皮下注射治疗,被随机分配接受猪胰岛素速秀霖+中效胰岛素锌混悬液(MC)混合制剂,或正规胰岛素+中性精蛋白生物合成人胰岛素混合制剂(研究1)。在研究2中,10名每日接受两次胰岛素注射的患者,被随机用猪胰岛素速秀霖+慢胰岛素锌悬液,或速秀霖+慢胰岛素锌悬液半合成人胰岛素,或正规胰岛素+中性精蛋白生物合成人胰岛素进行治疗。一旦获得最佳胰岛素治疗方案,就用两种(研究1)或三种(研究2)胰岛素制剂测定昼夜血糖和血浆游离胰岛素曲线(7 - 9个时间点),同时保持胰岛素剂量恒定。在研究1中,未观察到血糖(BG)或血浆游离胰岛素(FIRI)曲线有显著差异。两种类型的胰岛素在平均每日血糖、血糖波动幅度平均值(MAGE)、血糖控制指数(施利希特克鲁尔M值),以及早餐后血糖升高值和平均游离IRI方面相似。在研究2中,BG和FIRI曲线也相似,只是两种人胰岛素在晚上8:30时的BG显著较低(p小于0.02)。此时游离IRI未发现显著差异。平均BG、M指数、MAGE和平均FIRI相似,但早餐后血糖升高值在半合成人胰岛素时显著较小。总之,动物单组分胰岛素、半合成和生物合成人胰岛素的药代动力学似乎相似,但每日两次给予两种人胰岛素时,晚上的血糖控制更好。