Development of an Abbreviated Mycophenolic Acid Area Under the Time-Concentration Curve for Renal Transplant Patients Under Enteric-Coated Mycophenolate Sodium: A Comparison With Critical Analysis of Available Equations

被引:0
作者
David-Neto, Elias [1 ]
Triboni, Ana Heloisa [1 ]
Ramos, Fernanda [1 ]
Agena, Fabiana [1 ]
Romano, Paschoalina [2 ]
机构
[1] Univ Sao Paulo, Sch Med, Hosp Clin, Div Urol,Renal Transplantat Serv, Sao Paulo, Brazil
[2] Univ Sao Paulo, Hosp Clin, Sch Med, Div Cent Lab LIM 03, Sao Paulo, Brazil
关键词
MPA; abbreviated equation; renal transplantation; TDM; AUC; LIMITED SAMPLING STRATEGY; UNDER-THE-CURVE; RECIPIENTS; EXPOSURE; MOFETIL; TACROLIMUS;
D O I
10.1097/FTD.0000000000000529
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Background: Enteric-coated mycophenolate sodium is frequently used in renal transplantation. The pharmacokinetic profile of mycophenolic acid (MPA) shows a broad range of time-tomaximum concentration (T-max) that limits the use of a single MPA concentration to calculate the area under the time-concentration curve (AUC). For both research and clinical MPA monitoring, measuring a complete AUC is troublesome to the center and patients. Methods: We obtained 171 complete MPA-AUC(12h) (0, 20, 40, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes) from 59 adult (54 +/- 16 years) patients (29 men and 43 whites) who have been receiving stable doses of tacrolimus/enteric-coated mycophenolate sodium and steroids. We used the 59 curves drawn at 31 +/- 4 days after transplantation to develop the abbreviated equations, and the remaining 112 curves drawn at 109 +/- 59 days were used to validate them. We used 5 other proposed equations to estimate MPA-AUC (eAUC) (4 with enzyme-multiplied immunoassay technique assay and one with high-performance liquid chromatography [HPLC]) and then used these results to compare with our measured AUC, the bias, and the 10% and 30% accuracy. MPA was measured by ultraperformance liquid chromatography coupled to a tandem mass spectrometry, and AUC was calculated by the trapezoidal rule. Results: For both MPA-measuring methods, enzyme-multiplied immunoassay technique and ultraperformance liquid chromatography coupled to a tandem mass spectrometry, the Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP) equations, and others that measure MPA up to 6 hours after the dose had an acceptable low bias with more results in the 10%-30% range than those using data collected until 4 hours. A highly adequate eAUC is obtained using blood collected at 8 hours. Conclusions: This analysis offers blood-sampling alternatives for MPA monitoring depending on the precision needed.
引用
收藏
页码:411 / 416
页数:6
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