探索性分析移动医疗用药依从性干预对他克莫司谷浓度变异性的影响：一项随机对照试验的事后分析结果。
Exploratory Analysis of the Impact of an mHealth Medication Adherence Intervention on Tacrolimus Trough Concentration Variability: Post Hoc Results of a Randomized Controlled Trial.
机构信息
Medical University of South Carolina, Charleston, SC, USA.
出版信息
Ann Pharmacother. 2020 Dec;54(12):1185-1193. doi: 10.1177/1060028020931806. Epub 2020 Jun 8.
BACKGROUND
Medication nonadherence is a leading cause of late allograft loss in kidney transplantation (KT). Tacrolimus trough coefficient of variation (CV), measured using the coefficient of variation, is strongly correlated with acute rejection, graft function, and graft loss.
OBJECTIVE
The objective of this study was to determine if this mobile health (mHealth) intervention aimed at improving medication adherence in a nonadherent KT population would affect high intrapatient tacrolimus variability.
METHODS
A 6-month, prospective, parallel-arm, randomized controlled clinical trial was conducted to determine the effects of an mHealth intervention on tacrolimus CV. Intervention arm participants utilized an electronic medication tray and an mHealth app to monitor home-based adherence. Tailored motivational reinforcement messages were delivered to promote competence for adherence. Tacrolimus CV was measured using a 12-month rolling average, assessed at monthly intervals (6-month intervention period and 6 months after completion of the study); 80 were included, 40 in each arm.
RESULTS
At baseline, tacrolimus CV was similar between arms (37% ± 15% intervention, 37% ± 13% control, = 0.894). Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs ( = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; = 0.001), as compared with the control arm.
CONCLUSION AND RELEVANCE
High tacrolimus CV is a risk factor for acute rejection and graft loss; these results offer the potential promise of improved medication adherence and clinical outcomes through the use of innovative technology.
背景
药物依从性差是导致肾移植（KT）后移植物晚期丢失的主要原因。环孢素谷浓度变异系数（CV），通过变异系数测量，与急性排斥反应、移植物功能和移植物丢失密切相关。
目的
本研究旨在确定针对非依从性 KT 人群改善药物依从性的移动医疗（mHealth）干预措施是否会影响患者体内环孢素的高变异性。
方法
进行了一项为期 6 个月的前瞻性、平行臂、随机对照临床试验，以确定 mHealth 干预措施对环孢素 CV 的影响。干预组参与者使用电子药盒和 mHealth 应用程序来监测家庭用药依从性。通过提供个性化的激励信息来促进患者对药物的依从性。使用 12 个月滚动平均值来测量环孢素 CV，每月评估一次（干预期 6 个月和研究结束后 6 个月）；共纳入 80 例患者，每组 40 例。
结果
基线时，两组间环孢素 CV 相似（干预组 37%±15%，对照组 37%±13%， = 0.894）。与对照组相比，随机分配到干预组的患者 12 个月平均环孢素 CV 显著降低（ = 0.046），并且达到低环孢素 CV 比例显著增加（环孢素 CV <40%； = 0.001）。
结论和相关性
高环孢素 CV 是急性排斥反应和移植物丢失的危险因素；这些结果为通过使用创新技术提高药物依从性和临床结果提供了潜在的前景。
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