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肾移植超过1年的受者中与钙调神经磷酸酶抑制剂血药浓度变异性相关的因素。

Factors associated with the variability of calcineurin inhibitor blood levels in kidney recipients grafted for more than 1 year.

作者信息

Belaiche Stéphanie, Décaudin Bertrand, Dharancy Sébastien, Gautier Sophie, Noel Christian, Odou Pascal, Hazzan Marc

机构信息

Institut de pharmacie, CHU Lille, F-59000, Lille, France.

EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, Université Lille, F-59000, Lille, France.

出版信息

Fundam Clin Pharmacol. 2018 Feb;32(1):88-97. doi: 10.1111/fcp.12328. Epub 2017 Nov 10.

Abstract

The study of calcineurin inhibitor (CNI) blood level variability to evaluate adherence in transplantation has improved over the years. The aim of our study was to assess factors associated with this variability using the coefficient of variation (CV). A cross-sectional sample of kidney recipients grafted for more than 1 year was recruited. We recorded clinical data, data from a clinical pharmacist interview and from six questionnaires measuring adherence, satisfaction, behaviours, beliefs, perception of the illness and social vulnerability. A total of 408 recipients were enrolled (61.2% male, mean age 54) and divided into two groups: low variability CV < 30% (n = 302), high variability CV ≥ 30% (n = 106). In univariate analysis, hospital-home distance, cyclosporine, time since transplantation and presence of discrepancies in drug regimen were associated with a greater risk of CV ≥ 30%. In contrast, tacrolimus QD conferred a lower risk of CV ≥ 30%. In multivariate analysis, only the presence of discrepancies remained significant: (OR 3.2 [1.21-9.01]; P = 0.022). Discrepancies in drug regimen appear as the main risk factor associated with CNI blood variability. The clinical pharmacist's input is an accurate and simple way of detecting non-adherence which is not revealed in self-report questionnaires.

摘要

多年来,对钙调神经磷酸酶抑制剂(CNI)血药浓度变异性的研究不断改进,以评估移植患者的依从性。本研究旨在使用变异系数(CV)评估与这种变异性相关的因素。我们招募了移植超过1年的肾移植受者横断面样本。我们记录了临床数据、临床药师访谈数据以及六份用于测量依从性、满意度、行为、信念、疾病认知和社会脆弱性的问卷数据。共纳入408名受者(男性占61.2%,平均年龄54岁),并分为两组:低变异性组(CV<30%,n = 302),高变异性组(CV≥30%,n = 106)。在单因素分析中,医院到家的距离、环孢素、移植后的时间以及药物治疗方案存在差异与CV≥30%的风险增加相关。相比之下,他克莫司每日一次给药使CV≥30%的风险较低。在多因素分析中,只有治疗方案存在差异仍然具有统计学意义:(比值比3.2 [1.21 - 9.01];P = 0.022)。药物治疗方案的差异似乎是与CNI血药浓度变异性相关的主要危险因素。临床药师的参与是检测不依从性的一种准确且简单的方法,而这在自我报告问卷中并未体现。

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