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Kang,Y S,K Hirai,H Sato,A Tsuji 한국약제학회 1987 Journal of Pharmaceutical Investigation Vol.17 No.4
The receptor-mediated degradation and internalization of insulin have been studied in vitro, while simple pharmacokinetic models have been used for in vivo analysis. However, no pharmacokinetic analysis of insulin has been performed using physiological and biochemical parameters, such as binding to plasma proteins transcapillary permeability, tissue blood flow. blood-to-plasma partition coefficient, and receptor binding. Therefore, we used [^(125)I-Tyr^(A14) human insulin which possesses the same biological activity as native insulin, and analysed the plasma and tissue concentration time-courses using a physiologically-based pharmacokinetic model. The results were as follows: 1. The total body clearance after i.v. injection of tracer insulin and excess amount of unlabelled insulin almost corresponded to the glomerular filtration rate(9.7㎖/min/㎏), and the volume of distribution was in agreement with extracellular space(250 ㎖/㎏). 2. There was no significant difference between the renal clearance of insulin and the glomerular filtration rate, and the total body clearance after i.v. injection of tracer insulin was nearly equal to the sum of the hepatic clearance and the glomerular filtration rate. 3. Under the consideration of these results, physiological parameters, such as the transcapillary permeability and the affinity constant and capacity for the receptor binding were calculated by a nonlinear least squares regression analysis(NONLIN 74). Transcapillary permeability of insulin has a good correlation with that of inulin in each tissue.
( Keiji Hirai ),( Susumu Ookawara ),( Taisuke Kitano ),( Haruhisa Miyazawa ),( Kiyonori Ito ),( Yuichirou Ueda ),( Yoshio Kaku ),( Taro Hoshino ),( Honami Mori ),( Izumi Yoshida ),( Kenji Kubota ),( Y 대한신장학회 2017 Kidney Research and Clinical Practice Vol.36 No.2
Background: Mizoribine (MZR) is an immunosuppressive drug used in Japan for treating patients with lupus nephritis and nephrotic syndrome and has been also reportedly effective in patients with immunoglobulin A (IgA) nephropathy. However, to date, few randomized control studies of MZR are performed in patients with IgA nephropathy. Therefore, this prospective, open-label, randomized, controlled trial aimed to investigate the efficacy and safety of adding MZR to standard treatment in these patients, and was conducted between April 1, 2009, and March 31, 2016, as a multicenter study. Methods: Patients were randomly assigned (1:1) to receiving standard treatment plus MZR (MZR group) or standard treatment (control group). MZR was administered orally at a dose of 150 mg once daily for 12 months. Results: Primary outcomes were the percentage reduction in urinary protein excretion from baseline and the rate of patients with hematuria disappearance 36 months after study initiation. Secondary outcomes were the rate of patients with proteinuria disappearance, clinical remission rate, absolute changes in estimated glomerular filtration rate from baseline, and the change in daily dose of prednisolone. Forty-two patients were randomly assigned to MZR (n = 21) and control groups (n = 21). Nine patients in MZR group and 15 patients in the control group completed the study. No significant differences were observed between the two groups with respect to primary and secondary outcomes. Conclusion: The addition of MZR to standard treatment has no beneficial effect on reducing urinary protein excretion and hematuria when treating patients with IgA nephropathy.