Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.
Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
Am J Health Syst Pharm. 2021 Jul 9;78(14):1287-1293. doi: 10.1093/ajhp/zxab157.
Nonadherence is a leading cause of death-censored allograft loss in kidney transplant recipients. Strong associations have tied tacrolimus intrapatient variability (IPV) to degree of nonadherence and high tacrolimus IPV to clinical endpoints such as rejection and allograft loss. Nonadherence is a dynamic, complex problem best targeted by multidimensional interventions, including mobile health (mHealth) technologies.
This was a secondary planned analysis of a 12-month, parallel, 2-arm, semiblind, 1:1 randomized controlled trial involving 136 adult kidney transplant recipients. The primary aims of the TRANSAFE Rx study were to assess the efficacy of a pharmacist-led, mHealth-based intervention in improving medication safety and health outcomes for kidney transplant recipients as compared to usual care.
Patients were randomized equally to 68 patients per arm. The intervention arm demonstrated a statistically significant decrease in tacrolimus IPV over time as compared to the control arm (P = 0.0133). When analyzing a clinical goal of tacrolimus IPV of less than 30%, the 2 groups were comparable at baseline (P = 0.765), but significantly more patients in the intervention group met this criterion at month 12 (P = 0.033). In multivariable modeling, variables that independently impacted tacrolimus IPV included time, treatment effect, age, and warm ischemic time.
This secondary planned analysis of an mHealth-based, pharmacist-led intervention demonstrated an association between the active intervention in the trial and improved tacrolimus IPV. Further prospective studies are required to confirm the mutability of tacrolimus IPV and impact of reducing tacrolimus IPV on long-term clinical outcomes.
不遵医嘱是导致肾移植受者死亡相关移植物丢失的主要原因。已有强有力的证据表明，他克莫司个体内变异（IPV）与不遵医嘱的程度有关，而高他克莫司 IPV 则与排斥反应和移植物丢失等临床终点有关。不遵医嘱是一个动态的、复杂的问题，最好通过多维干预措施来解决，包括移动医疗（mHealth）技术。
这是一项为期 12 个月、平行、2 臂、半盲、1:1 随机对照临床试验的二次计划分析，涉及 136 名成年肾移植受者。TRANSAFE Rx 研究的主要目的是评估由药剂师主导的基于 mHealth 的干预措施在改善肾移植受者药物安全性和健康结果方面的疗效，与常规护理相比。
患者被平均随机分为每组 68 名患者。与对照组相比，干预组的他克莫司 IPV 随时间呈统计学显著下降（P = 0.0133）。当分析他克莫司 IPV 低于 30%的临床目标时，两组在基线时具有可比性（P = 0.765），但干预组在第 12 个月时达到这一标准的患者明显更多（P = 0.033）。在多变量模型中，独立影响他克莫司 IPV 的变量包括时间、治疗效果、年龄和热缺血时间。
对基于 mHealth 的、由药剂师主导的干预措施的这项二次计划分析表明，试验中的积极干预与改善他克莫司 IPV 之间存在关联。需要进一步的前瞻性研究来确认他克莫司 IPV 的可变性以及降低他克莫司 IPV 对长期临床结果的影响。
