Leichtle Alexander Benedikt, Ceglarek Uta, Witzigmann Helmut, Gäbel Gábor, Thiery Joachim, Fiedler Georg Martin
Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital Leipzig, 04103 Leipzig, Germany.
J Transplant. 2010;2010:201918. doi: 10.1155/2010/201918. Epub 2010 Jun 27.
Background. Close therapeutic drug monitoring of Cyclosporine (CsA) in transplant outpatients is a favourable procedure to maintain the long-term blood drug levels within their respective narrow therapeutic ranges. Compared to basal levels (C(0)), CsA peak levels (C(2)) are more predictive for transplant rejection. However, the application of C(2) levels is hampered by the precise time of blood sampling and the need of qualified personnel. Therefore, we evaluated a new C(2) self-obtained blood sampling in transplant outpatients using dried capillary and venous blood samples and compared the CsA levels, stability, and clinical practicability of the different procedures. Methods. 55 solid organ transplant recipients were instructed to use single-handed sampling of each 50 muL capillary blood and dried blood spots by finger prick using standard finger prick devices. We used standardized EDTA-coated capillary blood collection systems and standardized filter paper WS 903. CsA was determined by LC-MS/MS. The patients and technicians also answered a questionnaire on the procedure and sample quality. Results. The C(0) and C(2) levels from capillary blood collection systems (C(0) [ng/mL]: 114.5 +/- 44.5; C(2): 578.2 +/- 222.2) and capillary dried blood (C(0) [ng/mL]: 175.4 +/- 137.7; C(2): 743.1 +/- 368.1) significantly (P < .01) correlated with the drug levels of the venous blood samples (C(0) [ng/mL]: 97.8 +/- 37.4; C(2): 511.2 +/- 201.5). The correlation at C(0) was rho( (cap.-ven.) ) = 0.749, and rho( (dried blood-ven) ) = 0.432; at C(2): rho( (cap.-ven.) ) = 0.861 and rho( (dried blood-ven) ) = 0.711. The patients preferred the dried blood sampling because of the more simple and less painful procedure. Additionally, the sample quality of self-obtained dried blood spots for LC-MS/MS analytics was superior to the respective capillary blood samples. Conclusions. C(2) self-obtained dried blood sampling can easily be performed by transplant outpatients and is therefore suitable and cost-effective for close therapeutic drug monitoring.
背景。对移植门诊患者进行环孢素(CsA)的密切治疗药物监测是一种有利的方法,可将长期血药水平维持在各自狭窄的治疗范围内。与基础水平(C(0))相比,CsA峰值水平(C(2))对移植排斥反应的预测性更强。然而,C(2)水平的应用受到采血精确时间和对合格人员需求的限制。因此,我们评估了一种新的移植门诊患者自行采集C(2)血样的方法,使用干毛细血管血样和静脉血样,并比较了不同方法的CsA水平、稳定性和临床实用性。方法。指导55名实体器官移植受者使用标准手指采血装置,通过手指针刺单手采集每份50μL毛细血管血和干血斑。我们使用标准化的EDTA涂层毛细血管采血系统和标准化滤纸WS 903。通过液相色谱-串联质谱法(LC-MS/MS)测定CsA。患者和技术人员还回答了一份关于该方法和样本质量的问卷。结果。毛细血管采血系统的C(0)和C(2)水平(C(0) [ng/mL]:114.5±44.5;C(2):578.2±222.2)以及毛细血管干血的C(0)和C(2)水平(C(0) [ng/mL]:175.4±137.7;C(2):743.1±368.1)与静脉血样的药物水平(C(0) [ng/mL]:97.8±37.4;C(2):511.2±201.5)显著(P <.01)相关。C(0)时的相关性为rho( (cap.-ven.) ) = 0.749,rho( (dried blood-ven) ) = 0.432;C(2)时:rho( (cap.-ven.) ) = 0.861,rho( (dried blood-ven) ) = 0.711。患者更喜欢干血采样,因为该方法更简单且疼痛较轻。此外,用于LC-MS/MS分析的自行采集的干血斑样本质量优于相应的毛细血管血样。结论。移植门诊患者可轻松进行自行采集C(2)干血样,因此适用于密切治疗药物监测且具有成本效益。