Assessment of tacrolimus intrapatient variability in stable adherent transplant recipients: Establishing baseline values
Assessment of tacrolimus intrapatient variability in stable adherent transplant recipients: Establishing baseline values
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DOI：
10.1111/ajt.15199
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发表时间：
2019-05-01
影响因子：
8.8
通讯作者：
Rohan, Jennifer M.
中科院分区：
文献类型：
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作者：
Leino, Abbie D.;King, Eileen C.;Rohan, Jennifer M.
本研究的目的是确定他克莫司在依从性患者中的患者内（同一患者内）变异性。在肾和肝移植受者中，使用干血斑技术在家中获得每日他克莫司谷浓度。患者随机接受3种他克莫司制剂，每种制剂治疗2周。通过患者日记、药丸计数和药物事件监测系统（MEMS）的使用监测依从性。将变异性定量为变异系数（CV）。组间CV的比较通过独立t检验或单因素方差分析（如适用）进行。发现人群的依从率为99.9%，他克莫司夜间和早晨给药之间的平均间隔为11.86小时。整个人群的中位CV为15.2%（范围4.8%-110%）。同种异体移植物类型或他克莫司制剂的CV无差异。多变量分析未发现任何与CV > 30%相关的人口统计学特征。在高依从性人群中，他克莫司未显示高患者内变异性。考虑到IPV和移植物不良结局之间的相关性，需要进一步研究来量化依从性的影响并建立IPV目标。
The purpose of this study was to determine the intrapatient (within the same patient) variability of tacrolimus in adherent patients. Daily tacrolimus trough levels were obtained at home using dried blood spot technology in kidney and liver transplant recipients. Patients were randomized to receive 3 formulations of tacrolimus, each for two 1-week periods. Adherence was monitored by patient diary, pill counts, and use of the Medication Event Monitoring System (MEMS). Variability was quantified as the coefficient of variation (CV). Comparison of CV between groups was by independent t test or one-way ANOVA as appropriate. The population was found to be adherent with a rate of 99.9% with a mean interval between the evening and morning dose of tacrolimus of 11.86 hours. The median CV for the entire population was 15.2% (range 4.8%-110%). There were no differences in CV by allograft type or tacrolimus formulation. The multivariate analysis did not identify any demographic characteristics associated with a CV > 30%. In a highly adherent population, tacrolimus did not display high intrapatient variability. Given the association between IPV and poor allograft outcomes, future studies are needed to quantitate the influence of adherence and establish target IPV goals.