Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.
Transplant Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Sci Rep. 2021 Mar 8;11(1):5397. doi: 10.1038/s41598-021-84868-5.
This study analyzed the association between medication adherence and the intrapatient variability (IPV) of tacrolimus concentrations among kidney transplant recipients through a post hoc analysis of the dataset from a recently conducted randomized controlled trial. Among 138 patients enrolled in the original trial, 92 patients with ≥ 5 months of medication event monitoring system (MEMS) use and ≥ 4 tacrolimus trough values were included in this post hoc analysis. The variability of tacrolimus trough levels was calculated using coefficient variation (CV) and mean absolute deviation. Adherence was assessed using MEMS and self-report via the Basal Assessment of Adherence to Immunosuppressive Medication Scale. There were no statistically significant differences in the CV [median 16.5% [interquartile range 11.6-25.5%] and 16.0% [11.5-23.5%], respectively, P = .602] between the nonadherent (n = 59) and adherent groups (n = 33). There was also no significant correlation between the CV and adherence detected by MEMS (taking adherence, ρ = - 0.067, P = .527; dosing adherence, ρ = - 0.098, P = .352; timing adherence, ρ = - 0.113, P = .284). Similarly, adherence measured by self-report did not significantly affect the IPV (P = .452). In this post hoc analysis, nonadherent behavior, measured through electronic monitoring or self-report, did not affect the IPV.
本研究通过对最近进行的一项随机对照试验数据集的事后分析,分析了肾移植受者药物依从性与他克莫司浓度个体内变异(IPV)之间的关系。在原试验纳入的 138 名患者中,纳入了 92 名使用药物事件监测系统(MEMS)时间≥5 个月且有≥4 次他克莫司谷值的患者进行本事后分析。采用变异系数(CV)和平均绝对偏差来计算他克莫司谷值的变异性。通过 MEMS 和基于免疫抑制药物依从性基本评估量表的自我报告来评估依从性。在不依从组(n=59)和依从组(n=33)之间,CV 无统计学差异[中位数 16.5%(四分位距 11.6-25.5%)和 16.0%(11.5-23.5%),P=0.602]。通过 MEMS 检测到的 CV 与依从性之间也没有显著相关性(依从性,ρ=-0.067,P=0.527;剂量依从性,ρ=-0.098,P=0.352;时间依从性,ρ=-0.113,P=0.284)。同样,自我报告测量的依从性也不会显著影响 IPV(P=0.452)。在本事后分析中,通过电子监测或自我报告测量的不依从行为不会影响 IPV。