Baumann Pierre, Ulrich Sven, Eckermann Gabriel, Gerlach Manfred, Kuss Hans-Joachim, Laux Gerd, Müller-Oerlinghausen Bruno, Rao Marie Luise, Riederer Peter, Zernig Gerald, Hiemke Christoph
Department of Psychiatry, University of Lausanne, Prilly Lausanne, Switzerland.
Dialogues Clin Neurosci. 2005;7(3):231-47. doi: 10.31887/DCNS.2005.7.3/pbaumann.
Therapeutic drug monitoring (TDM) of psychotropic drugs such as antidepressants has been widely introduced for optimization of pharmacotherapy in psychiatric patients. The interdisciplinary TDM group of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) has worked out consensus guidelines with the aim of providing psychiatrists and TDM laboratories with a tool to optimize the use of TDM. Five research-based levels of recommendation were defined with regard to routine monitoring of drug plasma concentrations: (i) strongly recommended; (ii) recommended; (iii) useful; (iv) probably useful; and (v) not recommended. In addition, a list of indications that justify the use of TDM is presented, eg, control of compliance, lack of clinical response or adverse effects at recommended doses, drug interactions, pharmacovigilance programs, presence of a genetic particularity concerning drug metabolism, and children, adolescents, and elderly patients. For some drugs, studies on therapeutic ranges are lacking, but target ranges for clinically relevant plasma concentrations are presented for most drugs, based on pharmacokinetic studies reported in the literature. For many antidepressants, a thorough analysis of the literature on studies dealing with the plasma concentration-clinical effectiveness relationship allowed inclusion of therapeutic ranges of plasma concentrations. In addition, recommendations are made with regard to the combination of pharmacogenetic (phenotyping or genotyping) tests with TDM. Finally, practical instructions are given for the laboratory practitioners and the treating physicians how to use TDM: preparation of TDM, drug analysis, reporting and interpretation of results, and adequate use of information for patient treatment TDM is a complex process that needs optimal interdisciplinary coordination of a procedure implicating patients, treating physicians, clinical pharmacologists, and clinical laboratory specialists. These consensus guidelines should be helpful for optimizing TDM of antidepressants.
为优化精神病患者的药物治疗,抗抑郁药等精神药物的治疗药物监测(TDM)已被广泛采用。神经精神药理学与药物精神病学工作组(AGNP)的跨学科TDM小组制定了共识指南,旨在为精神科医生和TDM实验室提供优化TDM使用的工具。针对药物血浆浓度的常规监测定义了基于研究的五个推荐级别:(i)强烈推荐;(ii)推荐;(iii)有用;(iv)可能有用;(v)不推荐。此外,还列出了证明使用TDM合理的适应症清单,例如,控制依从性、在推荐剂量下缺乏临床反应或出现不良反应、药物相互作用、药物警戒计划、存在与药物代谢有关的遗传特殊性,以及儿童、青少年和老年患者。对于某些药物,缺乏关于治疗范围的研究,但基于文献报道的药代动力学研究,给出了大多数药物临床相关血浆浓度的目标范围。对于许多抗抑郁药,通过对有关血浆浓度 - 临床疗效关系的研究文献进行全面分析,纳入了血浆浓度的治疗范围。此外,还就药物遗传学(表型分析或基因分型)检测与TDM的联合应用提出了建议。最后,为实验室工作人员和治疗医生提供了关于如何使用TDM的实用指导:TDM的准备、药物分析、结果报告与解读,以及为患者治疗充分利用信息。TDM是一个复杂的过程,需要患者、治疗医生、临床药理学家和临床实验室专家之间进行最佳的跨学科协调。这些共识指南应有助于优化抗抑郁药的TDM。