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首页> 外文期刊>Clinical therapeutics >Time to reach tacrolimus maximum blood concentration,mean residence time, and acute renal allograft rejection: an open-label, prospective, pharmacokinetic study in adult recipients.
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Time to reach tacrolimus maximum blood concentration,mean residence time, and acute renal allograft rejection: an open-label, prospective, pharmacokinetic study in adult recipients.

机译：达到他克莫司最大血药浓度，平均停留时间和急性肾移植排斥反应的时间：一项针对成人接受者的开放性，前瞻性，药代动力学研究。

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OBJECTIVES: The aims of this study were to determine whether disposition-related pharmacokinetic parameters such as T(max) and mean residence time (MRT) could be used as predictors of clinical efficacy of tacrolimus in renal transplant recipients, and to what extent these parameters would be influenced by clinical variables. METHODS: We previously demonstrated, in a prospective pharmacokinetic study in de novo renal allograft recipients, that patients who experienced early acute rejection did not differ from patients free from rejection in terms of tacrolimus pharmacokinetic exposure parameters (dose interval AUC, preadministration trough blood concentration, C(max), dose). However, recipients with acute rejection reached mean (SD) tacrolimus T(max) significantly faster than those who were free from rejection (0.96 [0.56] hour vs 1.77 [1.06] hours; P < 0.001). Taking into account that neither differences in tacrolimus steady-state clearance nor T(1/2) could explain this unusual finding, we used data from the previous study to calculate MRT from the concentration-time curves. RESULTS: As part of the previous study, 100 patients (59 male, 41 female; mean [SD] age, 51.4 [13.8] years;age range, 20-75 years) were enrolled in the study The calculated MRT was significantly shorter in recipients with acute allograft rejection (11.32 [031] hours vs 11.52 [028] hours; P = 0.02), just like T(max) was an independent risk factor for acute rejection in a multivariate logistic regression model (odds ratio, 0.092 [95% CI, 0.014-0.629]; P = 0.01). Analyzing the impact of demographic, transplantation-related, and biochemical variables on MRT, we found that increasing serum albumin and hematocrit concentrations were associated with a prolonged MRT (P < 0.05). Conversely, serum albumin and hematocrit concentrations were significantly lower in recipients with acute rejection (P < (101). CONCLUSIONS: In this selected population of de novo renal allograft recipients, a shorter tacrolimus T(max) and calculated MRT were associated with a higher incidence of early acute graft rejection. These findings suggest that a shorter transit time of tacrolimus in certain tissue compartments, rather than failure to obtain a maximum absolute tacrolimus blood concentration, might lead to inadequate immunosuppression early after transplantation.
机译：目的：本研究的目的是确定与处置有关的药代动力学参数，例如T（max）和平均停留时间（MRT）是否可以用作他克莫司在肾移植受体中临床疗效的预测指标，以及这些参数在多大程度上会受到临床变量的影响。方法：我们先前在一项从头进行的同种异体肾移植受者进行的前瞻性药代动力学研究中证实，经历了急性急性排斥反应的患者与他克莫司的药物代谢动力学暴露参数（剂量间隔AUC，给药前谷血浓度， C（最大），剂量）。但是，急性排斥反应的接受者达到他克莫司平均（SD）T（max）的速度明显快于无排斥反应的接受者（0.96 [0.56]小时vs. 1.77 [1.06]小时; P <0.001）。考虑到他克莫司稳态清除率或T（1/2）的差异都不能解释这一不寻常的发现，我们使用先前研究的数据从浓度-时间曲线计算MRT。结果：作为先前研究的一部分，纳入了100例患者（男59例，女41例;平均[SD]年龄51.4 [13.8]岁;年龄范围20-75岁）。急性同种异体排斥反应的接受者（11.32 [031]小时vs 11.52 [028]小时; P = 0.02），就像T（max）是多因素Logistic回归模型中急性排斥反应的独立危险因素（赔率，0.092 [95] ％CI，0.014-0.629]; P ＝ 0.01）。分析人口统计学，移植相关和生化变量对MRT的影响，我们发现血清白蛋白和血细胞比容浓度的升高与MRT延长有关（P <0.05）。相反，急性排斥反应的接受者的血清白蛋白和血细胞比容浓度显着较低（P <（101）。结论）：在这一选择的从头移植肾脏接受者人群中，他克莫司T（max）越短和计算得出的MRT越高，这些发现表明，他克莫司在某些组织腔室中的转运时间较短，而不是未能获得最大他克莫司的绝对绝对血药浓度，可能导致移植后早期免疫抑制不足。

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