改善人格功能受损个体肝或肾移植后免疫抑制治疗的依从性——一项单中心随机对照可行性研究。
Improving adherence to immunosuppression after liver or kidney transplantation in individuals with impairments in personality functioning - A randomized controlled single center feasibility study.
作者信息
Wagner-Skacel Jolana, Fink Nadja, Kahn Judith, Dalkner Nina, Jauk Emanuel, Bengesser Susanne, Mairinger Marco, Schüssler Gerhard, Pieh Christoph, Stadlbauer Vanessa, Kirsch Alexander H, Zitta Sabine, Rosenkranz Alexander R, Fickert Peter, Schemmer Peter
机构信息
Department of Medical Psychology, Psychosomatics, and Psychotherapy, Medical University of Graz, Graz, Austria.
University Transplant Center Graz, Medical University of Graz, Graz, Austria.
出版信息
Front Psychol. 2023 Mar 9;14:1150548. doi: 10.3389/fpsyg.2023.1150548. eCollection 2023.
INTRODUCTION
Although adherence to immunosuppressive medication is the key factor for long-term graft survival today, 20-70% of transplant recipients are non-adherent to their immunosuppressive medication.
OBJECTIVE
A prospective, randomized, controlled single-center feasibility study was designed to evaluate the impact of a step guided multicomponent interprofessional intervention program for patients after kidney or liver transplantation on adherence to their immunosuppressive medication in daily clinical practice.
MATERIALS AND METHODS
The intervention consisted of group therapy and daily training as well as individual sessions in a step guided approach. The primary endpoint of the study was adherence to immunosuppression as assessed with the "Basel Assessment of Adherence to Immunosuppressive Medications Scale" (BAASIS). The coefficient of variation (CV%) of Tacrolimus (TAC) through levels and the level of personality functioning was a secondary endpoint. We conducted six monthly follow-up visits.
RESULTS
Forty-one age- and sex-matched patients [19 females, 58.5 ( = 10.56) years old, 22 kidney- and 19 liver transplantation] were randomized to the intervention- ( = 21) or control-group ( = 20). No differences between intervention- and control groups were found in the primary endpoint adherence and CV% of TAC. However, in further exploratory analyses, we observed that individuals with higher impairments in personality functioning showed higher CV% of TAC in the controls. The intervention might compensate personality-related susceptibility to poor adherence as evident in CV% of TAC.
DISCUSSION
The results of the feasibility study showed that this intervention program was highly accepted in the clinical setting. The Intervention group could compensate higher CV% of TAC after liver or kidney transplantation in individuals with lower levels of personality functioning and non-adherence.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, identifier NCT04207125.
引言
尽管坚持服用免疫抑制药物是目前移植器官长期存活的关键因素，但仍有20%-70%的移植受者不坚持服用免疫抑制药物。
目的
设计一项前瞻性、随机、对照单中心可行性研究，以评估肾脏或肝脏移植术后患者的多学科分步指导干预计划对日常临床实践中免疫抑制药物依从性的影响。
材料与方法
干预措施包括小组治疗、每日训练以及采用分步指导方法进行的个体辅导。研究的主要终点是使用“免疫抑制药物依从性巴塞尔评估量表”（BAASIS）评估的免疫抑制依从性。他克莫司（TAC）血药浓度的变异系数（CV%）和人格功能水平是次要终点。我们进行了6次月度随访。
结果
41名年龄和性别匹配的患者[19名女性，年龄58.5（±10.56）岁，22例肾移植和19例肝移植]被随机分为干预组（n = 21）或对照组（n = 20）。干预组和对照组在主要终点依从性和TAC的CV%方面未发现差异。然而，在进一步的探索性分析中，我们观察到对照组中人格功能受损程度较高的个体TAC的CV%更高。干预可能弥补了人格相关的依从性差的易感性，这在TAC的CV%中很明显。
讨论
可行性研究结果表明，该干预计划在临床环境中得到了高度认可。干预组可以弥补肝或肾移植后人格功能水平较低且不依从的个体中较高的TAC CV%。
临床试验注册
ClinicalTrials.gov，标识符NCT04207125。
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