Eberlin M, Otto G, Krämer I
Department of Pharmacy, University Medical Center, Mainz, Germany.
Transplant Proc. 2013 Jul-Aug;45(6):2314-20. doi: 10.1016/j.transproceed.2012.10.037. Epub 2013 May 29.
Compliance with immunosuppressive therapy plays a major role in the long-term success of liver transplantation. Thus, the development of strategies to promote compliance of liver transplant patients and its evaluation over time are of particular interest.
The main objective of this study was to compare medication compliance rates among liver transplant patients over time after transplantation where switched from a twice- to once-daily tacrolimus-based regimen.
Sixty-five liver transplant patients being administered tacrolimus-based therapy were classified into three subgroups with regard to time posttransplantation. Medication compliance with tacrolimus-based therapy was measured using an electronic medication event monitoring system over a 12-month period: for 6 months tacrolimus was administered twice-daily and for 6 months, once-daily. Dosing, taking, and timing compliance as well as drug holidays were compared intra-individually between twice- and once-daily intake and among the three subgroups. In addition, patient compliance and quality of life were evaluated using questionnaires.
A per protocol analysis of electronically obtained data showed 63 patients to be eligible. The resulting dosing, taking, and timing compliance rates of the patients were higher during the once-daily dosing period. No significant differences in compliance rates with tacrolimus therapy were observed among three subgroups independent of the dosing regimen. More patients failed the correct timing of the evening compared to the morning dose. Missing doses occurred particularly during weekends. Compliance variables measured by questionnaires (Morisky score, self-report, Medication Experience Scale for Immunosuppressants (MESI) score) and the Hospital Anxiety and Depression Scale score were similar in the two dosing periods. The short-form health survey (SF-36) score was higher with once-daily intake.
The high measured compliance rates did not vary significantly dependent upon the time after transplantation. Nevertheless, compliance rates were greater using once-daily tacrolimus dosing.
免疫抑制治疗的依从性对肝移植的长期成功起着重要作用。因此,制定促进肝移植患者依从性的策略并对其进行长期评估尤为重要。
本研究的主要目的是比较肝移植患者在从每日两次他克莫司给药方案转换为每日一次给药方案后的不同时间点的药物依从率。
65例接受以他克莫司为基础治疗的肝移植患者根据移植后的时间分为三个亚组。使用电子药物事件监测系统在12个月内测量以他克莫司为基础治疗的药物依从性:他克莫司每日给药两次,持续6个月,然后每日给药一次,持续6个月。比较每日两次和每日一次给药之间以及三个亚组之间个体内的给药、服药和时间依从性以及停药情况。此外,使用问卷评估患者的依从性和生活质量。
对电子获取的数据进行的符合方案分析显示63例患者符合条件。患者在每日一次给药期间的给药、服药和时间依从率更高。在不考虑给药方案的情况下,三个亚组之间他克莫司治疗的依从率没有显著差异。与早晨给药相比,更多患者晚上给药时间不正确。漏服剂量尤其发生在周末。两个给药期间通过问卷测量的依从性变量(Morisky评分、自我报告、免疫抑制剂药物体验量表(MESI)评分)和医院焦虑抑郁量表评分相似。每日一次服药时简短健康调查问卷(SF-36)评分更高。
所测得的高依从率并没有因移植后的时间而有显著差异。然而,每日一次服用他克莫司时的依从率更高。