文献詳細
特集 知っておきたい腎移植の最新情報—基礎から臨床まで
Ⅴ.免疫抑制法とTDM
文献概要
要旨 免疫抑制薬はNTI(narrow therapeutic index drugs)に分類され,通常の薬剤に比較して効果が得られつつ副作用を起こしにくい薬物の血中濃度の幅が非常に狭いことからTDM(therapeutic drug monitoring)が必要な薬剤と考えられている。腎移植後の免疫抑制療法は,導入療法(抗CD25抗体など)にCNI(CsA・TAC)と代謝拮抗薬(MMF,EVR,Mizoribin)±低用量ステロイドを組み合わせる多剤併用療法が標準である。免疫抑制薬同士や免疫抑制薬以外の併用薬との相互作用を熟知し,各薬剤に適したTDMによって適切な投与量設計を行うことが現在において安全にかつ効果的に使用する唯一の方法である。
参考文献
1)Johnston A:Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation. Eur J Hosp Pharm 20:302-307, 2013
2)日本TDM学会・日本移植学会(編):免疫抑制薬TDM標準化ガイドライン2014.金原出版,東京,2014
3)Mahalati K, Belitsky P, Sketris I, et al:Neoral monitoring by simplified sparse sampling area under the concentration-time curve:its relationship to acute rejection and cyclosporine nephrotoxicity early after kidney transplantation. Transplantation 68:55-62, 1999
4)Kovarik JM, Mueller EA, van Bree JB, et al:Cyclosporine pharmacokinetics and viability from a microemulsion formulation—a multicenter investigation in kidney transplant patients. Transplantation 58:658-663, 1994
5)Halloran PF, Helms LM, Kung L, et al:The temporal profile of calcineurin inhibition by cyclosporine in vivo. Transplantation 68:1356-1361, 1999
6)Thervet E, Pfffer P, Scolari MP, et al:Clinical outcomes during the first three months posttransplant in renal allograft recipients managed by C2 monitoring of cyclosporine microemulsion. Transplantation 76:903-908, 2003
monitoring in de novo kidney transplant patients:a prospective randomized single-center pilot study. Transplantation 81:1010-1015, 2006
8)Undre NA, van Hooff J, Christiaans M, et al:Low systemic exposure to tacrolimus correlates with acute rejection. Transplant Proc 31:296-298, 1999
9)Armendariz Y, Pou L, Cantarell C, et al:Evaluation of a limited sampling strategy to estimate area under the curve of tacrolimus in adult renal transplant patients. Ther Drug Monit 27:431-434, 2005
10)Ekberg H, Tedesco-Silva H, Demirbas A, et al:Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med 357:2562-2575, 2007
11)E kberg H, Bernasconi C, Tedesco-Silva H, et al:Calcineurin inhibitor minimization in the Symphony study:observational results 3 years after transplantation. Am J Transplant 9:1876-1885, 2009
12)Satoh S, Kagaya H, Saito M, et al:Lack of tacrolimus circadian pharmacokinetics and CYP3A5 pharmacogenetics in the early and maintenance stages in Japanese renal transplant recipients. Br J Clin Pharmacol 66:207-214, 2008
13)MacPhee IA, Federicks S, Tai T, et al:The influence of pharmacogenetics on the time to achieve target tacrolimus concentrations after kidney transplantation. Am J Transplant 4:914-919, 2004
14)van Gelder T, Silva HT, de Fijter JW, et al:Comparing mycophenolate mofetil regimens for de novo renal transplant recipients:the fixed-dose concentration-controlled trial. Transplantation 86:1043-1051, 2008
15)van Gelder T, Tedesco Silva H, de Fijter JW, et al:Renal transplant patients at high risk of acute rejection benefit from adequate exposure to mycophenolic acid. Transplantation 89:595-599, 2010
16)Le Meura Y, Büchlerb M, Thierry A, et al:Individualized mycophenolate mofetil dosing based on drug exposure significantly improves patient outcomes after renal transplantation. Am J of Transplant 7:2496-2503, 2007
17)Arns W, Cibrik DM, Walker RG, et al:Therapeutic drug monitoring of mycophenolic acid in solid organ transplant patients treated with mycophenolate mofetil:review of the literature. Transplantation 82:1004-1012, 2006
18)Knight SR and Morris PJ:Does the evidence support the use of mycophenolate mofetil therapeutic drug monitoring in clinical practice? a systematic Review. Transplantation 85:1675-1685, 2008
19)Staatz CE and Tett SE:Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clinical Pharmacokinet 46:13-58, 2007
20)Smak Gregoor PJM, van Gelder T, HessecJ, et al:Mycophenolic acid plasma concentrations in kidney allograft recipients with or without cyclosporine:a cross-sectional study. Nephrol Dial Transplant 29:706-708, 1999
21)Undre NA, vanHoof J, Christiaans M, et al:Pharmacokinetics of FK 506 and mycophenolic acid after the administration of a FK 506-based regimen in combination with mycophenolate mofetil in kidney transplantation. Transplant Proc 30:1299-1302, 1998
22)Schuler W, Sedrani R, Cottens S, et al:SDZ RAD, a new rapamycin derivative:pharmacological properties in vitro and in vivo. Transplantation 64:36-42, 1997
23)Schuurman HJ, Ringers J, Schuler W, et al:Oral efficacy of the macrolide immunosuppressant SDZ RAD and of cyclosporine microemulsion in cynomolgus monkey kidney allotransplantation. Transplantation 69:737-742, 2000
24)Delgado JF, Manito N, Segovia J, et al:The use of proliferation signal inhibitors in the prevention and treatment of allograft vasculopathy in heart transplantation. Transplant Rev 23:69-79, 2009
25)Weir MR, Mulgaonkar S, Chan L, et al:Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation:a randomized, controlled Spare-the-Nephron trial. Kidney Int 79:897-907, 2011
26)Schena FP, Pascoe MD, Alberu J, et al:Conversion from calcineurin inhibitors to sirolimus maintenance therapy in renal allograft recipients:24-month efficacy and safety results from the CONVERT trial. Transplantation 87:233-242, 2009
27)Budde K, Becker T, Arns W, et al:Everolimus-based, calcineurin-inhibitor-free regimen in recipients of de-novo kidney transplants:an open-label, randomised, controlled trial. Lancet 377:837-847, 2011
28)Tedesco Silva H Jr, Cibrik D, Johnston T, et al:Everolimus plus reduced-exposure CsA versus mycophenolic acid plus standard-exposure CsA in renal-transplant recipients. Am J Transplant 10:1401-1413, 2010
29)Langer RM, Hené R, Vitko S, et al:Everolimus plus early tacrolimus minimization:a phase Ⅲ, randomized, open-label, multicentre trial in renal transplantation. Transpl Int 25:592-602, 2012
30)Nankivell BJ, Borrows RJ, Fung CL, et al:The natural history of chronic allograft nephropathy. N Engl J Med 349:2326-2333, 2003
31)Nankivell BJ, Borrows RJ, Fung CL, et al:Calcineurin inhibitor nephrotoxicity:longitudinal assessment by protocol histology. Transplantation 78:557-565, 2004
32)Kovarik JM, Kalbag J, Figueiredo J, et al:Differential influence of two cyclosporine formulations on everolimus pharmacokinetics:a clinically relevant pharmacokinetic interaction. J Clin Pharmacol 42:95-99, 2002
33)Sigal NH and Dumont FJ:Cyclosporin A, FK-506, and rapamycin:pharmacologic probes of lymphocyte signal transduction. Annu Rev Immunol 10:519-560, 1992
34)平光高久,島袋修一,後藤憲彦,他:ミゾリビン血中濃度の周術期詳細研究.今日の移植21:657-659,2008
35)Akiyama T, Okazaki H, Takahashi K, et al:Mizoribine in combination therapy with tacrolimus for living donor renal transplantation:analysis of a nationwide study in Japan. Transplant Proc 37:843-845, 2005
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