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完整後設資料紀錄
DC 欄位 | 值 | 語言 |
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dc.contributor.advisor | 林慧玲(Fe-Lin Lin Wu),蔡孟昆(Meng-Kun Tsai) | |
dc.contributor.author | Hsuan-Ping Chang | en |
dc.contributor.author | 張瑄玶 | zh_TW |
dc.date.accessioned | 2021-06-15T16:45:42Z | - |
dc.date.available | 2020-09-24 | |
dc.date.copyright | 2015-09-24 | |
dc.date.issued | 2015 | |
dc.date.submitted | 2015-08-10 | |
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Pharmacological research : the official journal of the Italian Pharmacological Society 2006;54:181-5. 10. Undre NA, van Hooff 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. Transplantation proceedings 1998;30:1299-302. 11. Shihab F, Christians U, Smith L, Wellen JR, Kaplan B. Focus on mTOR inhibitors and tacrolimus in renal transplantation: pharmacokinetics, exposure-response relationships, and clinical outcomes. Transplant immunology 2014;31:22-32. 12. Mourad M, Wallemacq P, Konig J, et al. Therapeutic monitoring of mycophenolate mofetil in organ transplant recipients: is it necessary? Clinical pharmacokinetics 2002;41:319-27. 13. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clinical pharmacokinetics 2007;46:13-58. 14. Dean PG, Lund WJ, Larson TS, et al. 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Kelly PA, Gruber SA, Behbod F, Kahan BD. Sirolimus, a new, potent immunosuppressive agent. Pharmacotherapy 1997;17:1148-56. 25. Kirchner GI, Meier-Wiedenbach I, Manns MP. Clinical pharmacokinetics of everolimus. Clinical pharmacokinetics 2004;43:83-95. 26. Pascual J, del Castillo D, Cabello M, et al. Interaction between everolimus and tacrolimus in renal transplant recipients: a pharmacokinetic controlled trial. Transplantation 2010;89:994-1000. 27. Crowe A, Bruelisauer A, Duerr L, Guntz P, Lemaire M. Absorption and intestinal metabolism of SDZ-RAD and rapamycin in rats. Drug metabolism and disposition: the biological fate of chemicals 1999;27:627-32. 28. Sanchez-Fructuoso AI. Everolimus: an update on the mechanism of action, pharmacokinetics and recent clinical trials. Expert opinion on drug metabolism toxicology 2008;4:807-19. 29. Halleck F, Duerr M, Waiser J, et al. An evaluation of sirolimus in renal transplantation. Expert opinion on drug metabolism toxicology 2012;8:1337-56. 30. Stenton SB, Partovi N, Ensom MH. Sirolimus: the evidence for clinical pharmacokinetic monitoring. Clinical pharmacokinetics 2005;44:769-86. 31. Cooper JE, Christians U, Wiseman AC. Everolimus in kidney transplantation. Transpl Res Risk Manag 2011;3:97-112. 32. Product Information: CellCept(R) oral capsules, mycophenolate mofetil oral capsules. Roche S.p.A., Via Morelli, Segrate, 2012. 33. Braun F, Schocklmann H, Ziegler E, Kunzendorf U, Armstrong VW, Renders L. Increased mycophenolic acid exposure in stable kidney transplant recipients on tacrolimus as compared with those on sirolimus: implications for pharmacokinetics. Clinical pharmacology and therapeutics 2009;86:411-5. 34. Park SI, Felipe CR, Pinheiro-Machado PG, et al. Tacrolimus pharmacokinetic drug interactions: effect of prednisone, mycophenolic acid or sirolimus. Fundamental clinical pharmacology 2009;23:137-45. 35. Kuypers DR, Claes K, Evenepoel P, Maes B, Vanrenterghem Y. Long-term pharmacokinetic study of the novel combination of tacrolimus and sirolimus in de novo renal allograft recipients. Therapeutic drug monitoring 2003;25:447-51. 36. Kovarik JM, Curtis JJ, Hricik DE, Pescovitz MD, Scantlebury V, Vasquez A. Differential pharmacokinetic interaction of tacrolimus and cyclosporine on everolimus. Transplantation proceedings 2006;38:3456-8. 37. Brandhorst G, Tenderich G, Zittermann A, et al. Everolimus exposure in cardiac transplant recipients is influenced by concomitant calcineurin inhibitor. Therapeutic drug monitoring 2008;30:113-6. 38. Chan L, Hartmann E, Cibrik D, Cooper M, Shaw LM. Optimal everolimus concentration is associated with risk reduction for acute rejection in de novo renal transplant recipients. Transplantation 2010;90:31-7. 39. Zucker K, Rosen A, Tsaroucha A, et al. Augmentation of mycophenolate mofetil pharmacokinetics in renal transplant patients receiving Prograf and CellCept in combination therapy. Transplantation proceedings 1997;29:334-6. 40. Pirsch J, Bekersky I, Vincenti F, et al. Coadministration of tacrolimus and mycophenolate mofetil in stable kidney transplant patients: pharmacokinetics and tolerability. Journal of clinical pharmacology 2000;40:527-32. 41. Rostaing L, Christiaans MH, Kovarik JM, Pascual J. The pharmacokinetics of everolimus in de novo kidney transplant patients receiving tacrolimus: an analysis from the randomized ASSET study. Annals of transplantation : quarterly of the Polish Transplantation Society 2014;19:337-45. 42. ARCHITECT Tacrolimus reg; [package insert]. Malvern, PA: Abbott Laboratories; 2012. . 43. Burton, M. E. (2006). Applied pharmacokinetics pharmacodynamics: Principles of therapeutic drug monitoring. Baltimore: Lippincott Williams Wilkins. . 44. Shargel L, Wu-Pong S, Yu A. Introduction to Biopharmaceutics and Pharmacokinetics. Applied Biopharmaceutics Pharmacokinetics. 5 ed2005:7. 45. Garbe E, R ouml;hmel J, Gundert-Remy U. Clinical and statistical issues in therapeutic equivalence trials. European journal of clinical pharmacology 1993;45:1-7. 46. Filler G, Womiloju T, Feber J, Lepage N, Christians U. Adding sirolimus to tacrolimus-based immunosuppression in pediatric renal transplant recipients reduces tacrolimus exposure. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 2005;5:2005-10. 47. Kuypers DR, Claes K, Evenepoel P, Maes B, Vanrenterghem Y. The rate of gastric emptying determines the timing but not the extent of oral tacrolimus absorption: simultaneous measurement of drug exposure and gastric emptying by carbon-14-octanoic acid breath test in stable renal allograft recipients. Drug metabolism and disposition: the biological fate of chemicals 2004;32:1421-5. 48. Mendonza AE, Zahir H, Gohh RY, Akhlaghi F. Tacrolimus in diabetic kidney transplant recipients: pharmacokinetics and application of a limited sampling strategy. Therapeutic drug monitoring 2007;29:391-8. 49. Shargel L, Wu-Pong S, Yu A. Pharmacokinetics of Oral Absorption. Applied Biopharmaceutics Pharmacokinetics2005:176. 50. Kalliokoski A, Niemi M. Impact of OATP transporters on pharmacokinetics. British journal of pharmacology 2009;158:693-705. 51. Bramow S, Ott P, Thomsen Nielsen F, Bangert K, Tygstrup N, Dalhoff K. Cholestasis and regulation of genes related to drug metabolism and biliary transport in rat liver following treatment with cyclosporine A and sirolimus (Rapamycin). Pharmacology toxicology 2001;89:133-9. 52. Picard N, Levoir L, Lamoureux F, Yee SW, Giacomini KM, Marquet P. Interaction of sirolimus and everolimus with hepatic and intestinal organic anion-transporting polypeptide transporters. Xenobiotica; the fate of foreign compounds in biological systems 2011;41:752-7. 53. Product Information: CellCept(R) oral capsules, tablets, suspension, mycophenolate mofetil oral capsules, tablets, suspension. Genentech USA, Inc. (per FDA), South San Francisco, CA. 2012. 54. Abu-Elmagd K, Fung JJ, Alessiani M, et al. The effect of graft function on FK506 plasma levels, dosages, and renal function, with particular reference to the liver. Transplantation 1991;52:71-7. 55. Abu-Elmagd KM, Fung JJ, Alessiani M, et al. Strategy of FK 506 therapy in liver transplant patients: effect of graft function. Transplantation proceedings 1991;23:2771-4. 56. Pou L, Brunet M, Andres I, Rodamilans M, Lopez R, Corbella J. Influence of posttransplant time on dose and concentration of tacrolimus in liver transplant patients. Transplant international : official journal of the European Society for Organ Transplantation 1998;11 Suppl 1:S270-1. 57. Jain AB, Abu-Elmagd K, Abdallah H, et al. Pharmacokinetics of FK506 in liver transplant recipients after continuous intravenous infusion. Journal of clinical pharmacology 1993;33:606-11. 58. Chitnis SD, Ogasawara K, Schniedewind B, Gohh RY, Christians U, Akhlaghi F. Concentration of tacrolimus and major metabolites in kidney transplant recipients as a function of diabetes mellitus and cytochrome P450 3A gene polymorphism. Xenobiotica; the fate of foreign compounds in biological systems 2013;43:641-9. 59. Zuo X-c, Zhou Y-n, Zhang B-k, et al. Effect of CYP3A5*3 polymorphism on pharmacokinetic drug interaction between tacrolimus and amlodipine. Drug Metabolism And Pharmacokinetics 2013;28:398-405. 60. Zhao W, Baudouin V, Fakhoury M, Storme T, Deschenes G, Jacqz-Aigrain E. Pharmacokinetic interaction between tacrolimus and amlodipine in a renal transplant child. Transplantation 2012;93:e29-30. 61. Braun F, Peters B, Schutz E, et al. Therapeutic drug monitoring of tacrolimus early after liver transplantation. Transplantation proceedings 2002;34:1538-9. 62. Jorgensen K, Povlsen J, Madsen S, et al. C2 (2-h) levels are not superior to trough levels as estimates of the area under the curve in tacrolimus-treated renal-transplant patients. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association 2002;17:1487-90. 63. Pisitkun T, Eiam-Ong S, Chusil S, Praditpornsilpa K, Pansin P, Tungsanga K. The roles of C4 and AUC0-4 in monitoring of tacrolimus in stable kidney transplant patients. Transplantation proceedings 2002;34:3173-5. 64. Hariharan S, Tomlanovich SJ, Filo RS, Dessimoz M, Wisemandle W, Townsend RW. Pharmacokinetics (PK) and tolerability of tacrolimus and sirolimus combination therapy in stable renal transplant recipients. Am J Transplant 2002;1 (Suppl 1):406 (Abstract 1074). 65. Undre NA. Pharmacokinetics of tacrolimus-based combination therapies. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association 2003;18 Suppl 1:i12-5. 66. Undre NA, van Hooff J, Christiaans M, Wallemacq PE, Squifflet JP, Stevenson PJ. Pharmacokinetics (PK) of tacrolimus (tac) and rapamycin (rapa) following the administration of different doses of rapa in combination with tac in kidney transplantation. 2nd International Congress on Immunosuppression, San Diego 2002;127: (Abstract P‐66). 67. Tortorici MA, Parks V, Matschke K, Korth-Bradley J, Patat A. The evaluation of potential pharmacokinetic interaction between sirolimus and tacrolimus in healthy volunteers. European journal of clinical pharmacology 2013;69:835-42. | |
dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/53122 | - |
dc.description.abstract | 簡介: 有關everolimus (EVL) 對tacrolimus (TAC) 藥品動態學 (簡稱藥動學) 影響的研究很少,且結果並不一致,而過去研究顯示mycophenolate mofetil (MMF) 對於TAC藥動學的影響很小,未達統計上差異,故本研究欲以MMF-TAC為對照組,探討EVL對TAC藥動學的影響。 方法: 本研究為一前瞻性、隨機分配、開放性試驗,納入初次接受腎臟移植且年齡在20-65歲的病人,排除條件包括:懷孕、再移植或多重器官移植、人類免疫缺乏病毒反應呈陽性、B型或C型肝炎帶原、胺基轉化酶數值在正常值上限的兩倍以上,以及有類風濕關節炎病史。病人納入後隨機分成兩組:EVL (1 mg bid) /TAC/類固醇和MMF (10-15 mg/kg bid) /TAC/類固醇,且調整TAC劑量以達到目標谷濃度 (Ctrough) 8-12 ng/mL,當TAC與EVL血中濃度達穩定狀態後,分別在給藥前及給藥後1、2、3、5、8、12小時抽血,TAC全血濃度以延遲性一步驟免疫分析法 (delayed one-step immunoassay) 測定,EVL全血濃度以免疫濁度法 (turbidimetric immunoassay) 測定。藥動學參數使用WinNonLin的non-compartmental analysis計算;統計分析方法,在連續性變項使用independent t-test,類別變項使用Fisher’s exect test,相關性使用Spearman rank correlation分析。 結果: 本研究納入15位病人,其中三位分別因為輸尿管狹窄、腸胃道出血和未遵守protocol退出研究,最後共有12位病人完成試驗;兩組病人的年齡、性別、體重、肝腎功能、白蛋白沒有差異;TAC劑量在EVL組需為MMF組的2倍 (5.0±1.3 vs. 2.5±0.7 mg bid,p <0.01) 才能達到目標Ctrough。與MMF組相比,EVL組的TAC劑量校正Ctrough低61% (1.23±0.32 vs. 3.13±1.15 ng/mL/mg,p = 0.009)、TAC劑量校正濃度-時間曲線下面積 (area under the curve,AUC0-12) 低47% (29.00±6.22 vs. 55.14±17.32 hr*ng/mL/mg,p = 0.012)、TAC劑量校正峰濃度 (Cmax) 低37% (5.32±1.31 vs. 8.48±1.85 ng/mL/mg,p = 0.009)、TAC口服清除率 (CL/F) 高51% (0.62±0.12 vs. 0.41±0.20 ng/mL/mg,p = 0.044)。此外,MMF組的TAC Ctrough與AUC0-12線性相關性較EVL組高 (r = 0.94 vs. 0.66),所有病人在給藥後第5小時血中濃度 (C5) 與AUC0-12相關性最高。 結論: 在新腎臟移植病人,使用TAC/EVL/類固醇比起TAC/MMF/類固醇,TAC的體內暴露量低61%,且TAC併用EVL比起併用MMF,需要2倍劑量來達到相同目標Ctrough;因此,若TAC在合併EVL或MMF治療之間作轉換,TAC的Ctrough須密切監測,且TAC劑量須調整。 | zh_TW |
dc.description.abstract | Introduction: Studies on the effect of everolimus (EVL) on tacrolimus (TAC) pharmacokinetics (PK) were limited and the results were inconsistent. In contrast, studies showed that mycophenolate mofetil (MMF) had limited effect on tacrolimus PK. This study investigated the influence of EVL on TAC PK, using MMF-TAC combination as a control. Methods: This was a prospective, randomized, open-label study. De novo renal transplant recipients aged 20-65 years were included. Exclusion criteria were pregnancy, retransplantation or multiorgan transplantation, positive for human immunodeficiency virus, hepatitis B or C virus, aminotransferase level ≥ 2 times the upper limit of normal, and history of rheumatoid arthritis. Patients were randomized to receive either EVL (1 mg bid) or MMF (10-15 mg/kg bid) in combination with TAC and corticosteroids. Doses of TAC were adjusted to maintain trough concentration in the range of 8-12 ng/mL. Steady-state PK profiles of TAC and EVL using whole blood sample were taken just before and 1, 2, 3, 5, 8, 12 hour after drug administration. TAC and EVL were analyzed in whole blood sample by delayed one-step immunoassay and tturbidimetric immunoassay respectively. PK parameters were evaluated by noncompartmental methods using WinNonLin. Continuious and categorical variables were analyzed with unpaired two-tailed t test and Fisher’s exact test, respectively. Correlations were analyzed with Spearman’s correlation coefficient. Results: Fifteen patients were enrolled in the study. Three patients dropped out because of ureteral stenosis, gastrointestinal bleeding or protocol violation; thus, 12 patients completed the study. There were no significant differences in age, gender, weight, renal function, liver function, and albumin level between the two groups.TAC dosage required to maintain the same target trough concentration (Ctrough) in EVL group was 2 times higher than in MMF group (5.0±1.3 vs. 2.5±0.7 mg bid,p <0.01). Compared to MMF group, dose-normalized TAC Ctrough was 61% lower (1.23±0.32 vs. 3.13±1.15 ng/mL/mg,p = 0.009) and dose-normalized TAC area under the curve (AUC0-12) was 47% lower (29.00±6.22 vs. 55.14±17.32 hr*ng/mL/mg,p = 0.012) in EVL group. In EVL group, dose-normalized TAC peak concentration (Cmax) was 37% lower (5.32±1.31 vs. 8.48±1.85 ng/mL/mg,p = 0.009) and TAC oral clearance (CL/F) was 51% higher (0.62±0.12 vs. 0.41±0.20 ng/mL/mg,p = 0.044) than those in MMFgroup. In addition, we observed a better linear correlation between TAC Ctrough and AUC0-12 in MMF group than that in EVL group (r = 0.94 vs. 0.66). TAC concentration at 5 hour after drug administration (C5) correlated the best with AUC0-12 in all patients. Conclusion: In de novo renal transplant recipients, when combined with EVL, TAC exposure was 61% lower than when combined with MMF. TAC dosage had to be doubled to maintain same target Ctrough in everolimus-treated patients than in MMF-treated patients. TAC dosage should be adjusted, and Ctrough should be closely monitored when switch between EVL and MMF combination. | en |
dc.description.provenance | Made available in DSpace on 2021-06-15T16:45:42Z (GMT). No. of bitstreams: 1 ntu-104-R02451009-1.pdf: 1662529 bytes, checksum: f2062d516381f6ac995ca61df39d07e7 (MD5) Previous issue date: 2015 | en |
dc.description.tableofcontents | 論文口試委員審定書:I 致謝:II 中文摘要:III Abstract:V 目錄:VII 圖目錄:IX 表目錄:X 第1章 前言:1 第2章 文獻探討:2 2.1 免疫抑制劑的臨床使用情形:2 2.2 Tacrolimus藥品動態學:3 2.2.1 吸收:3 2.2.2 分布:4 2.2.3 代謝和排除:4 2.3 Everolimus藥品動態學:4 2.4 MMF藥品動態學:5 2.5 Sirolimus、everolimus和MMF對tacrolimus藥動學的影響:5 2.5.1 Sirolimus對Tacrolimus藥品動態學的影響:5 2.5.2 Everolimus對tacrolimus藥品動態學的影響:6 2.5.3 MMF對tacrolimus藥品動態學的影響:8 2.5.4 Tacrolimus對everolimus藥品動態學的影響:8 第3章 研究目的及方法:10 3.1 研究目的:10 3.2 研究方法:10 3.2.1 研究架構:10 3.2.2 病人:10 3.2.3 免疫抑制劑治療:10 3.2.4 併用藥品:11 3.2.5 藥動學與藥品血中濃度檢驗方法:11 3.2.6 其它實驗室檢查:13 3.2.7 藥動學參數:13 3.2.8 統計分析:14 第4章 研究結果:16 4.1 病人人口學資料:16 4.2 排斥發生率及不良反應:16 4.3 免疫抑制劑:17 4.4 藥品動態學:17 4.5 相關性分析:18 第5章 討論:19 5.1 研究結果與過去文獻之比較:19 5.2 探討everolimus如何影響tacrolimus藥動學:21 5.3 其他影響tacrolimus藥動學的因素:22 5.4 相關性研究:24 第6章 結論:26 圖表:33 附錄:67 | |
dc.language.iso | zh-TW | |
dc.title | 在新腎臟移植病人Everolimus對Tacrolimus藥動學的影響:以Mycophenolate Mofetil作為對照組 | zh_TW |
dc.title | Effect of Everolimus on Tacrolimus Pharmacokinetics in De Novo Renal Transplant Recipients: Using Mycophenolate Mofetil as a Control | en |
dc.type | Thesis | |
dc.date.schoolyear | 103-2 | |
dc.description.degree | 碩士 | |
dc.contributor.oralexamcommittee | 沈麗娟(Li-Jiuan Shen) | |
dc.subject.keyword | tacrolimus,everolimus,mycophenolate mofetil,腎移植,藥品動態學,藥品交互作用,免疫抑制劑, | zh_TW |
dc.subject.keyword | tacrolimus,everolimus,mycophenolate mofetil,kidney transplant,pharmacokinetics,drug interaction,immunosuppressants, | en |
dc.relation.page | 78 | |
dc.rights.note | 有償授權 | |
dc.date.accepted | 2015-08-10 | |
dc.contributor.author-college | 藥學專業學院 | zh_TW |
dc.contributor.author-dept | 臨床藥學研究所 | zh_TW |
顯示於系所單位: | 臨床藥學研究所 |
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