Kiang Tony K L, Ensom Mary H H
a Faculty of Pharmaceutical Sciences , The University of British Columbia , Vancouver , British Columbia , Canada.
b Department of Pharmacy , Vancouver General Hospital , Vancouver , British Columbia , Canada.
Expert Opin Drug Metab Toxicol. 2016 May;12(5):545-53. doi: 10.1517/17425255.2016.1170806. Epub 2016 Apr 7.
Mycophenolate (MPA) therapeutic drug monitoring (TDM) in adult solid organ transplant recipients was summarized extensively in consensus reports published between 2009 and 2011. Thus, this review provides an update on the science of MPA TDM over the past 5 years.
PubMed and Google Scholar (January 2010-January 2016) were searched; relevant articles from bibliographies of identified articles were extracted for further review. New evidence on TDM-guided dosing in MPA efficacy and toxicity and best approaches for estimating MPA area-under-the-curve for TDM were retrieved.
Since 2011, little advancement in consensus on MPA TDM has been established for any type of solid organ transplant. Lack of systematic studies validating or further defining MPA's target range suggests that routine TDM is still unwarranted. Accurate, precise, and user-friendly limited sampling strategies (LSSs) are available in specific patient populations taking mycophenolate mofetil but not enteric-coated mycophenolate sodium. In absence of outcome data, routine use of LSSs in MPA TDM still cannot be recommended. Further research should attempt to define factors that modulate MPA's pharmacokinetics to elucidate their impact on utility of TDM. Future studies should also validate LSSs in larger patient populations and demonstrate benefits of LSSs in improving patient outcomes.
2009年至2011年间发表的共识报告广泛总结了成人实体器官移植受者的霉酚酸(MPA)治疗药物监测(TDM)情况。因此,本综述提供了过去5年MPA TDM科学的最新进展。
检索了PubMed和谷歌学术(2010年1月 - 2016年1月);从已识别文章的参考文献中提取相关文章进行进一步审查。检索了关于TDM指导剂量对MPA疗效和毒性影响的新证据以及TDM中估计MPA曲线下面积的最佳方法。
自2011年以来,对于任何类型的实体器官移植,MPA TDM的共识进展甚微。缺乏验证或进一步界定MPA目标范围的系统研究表明,常规TDM仍然没有必要。在服用吗替麦考酚酯而非肠溶型麦考酚钠的特定患者群体中,有准确、精确且用户友好的有限采样策略(LSS)。在缺乏结局数据的情况下,仍不建议在MPA TDM中常规使用LSS。进一步的研究应尝试确定调节MPA药代动力学的因素,以阐明它们对TDM效用的影响。未来的研究还应在更大的患者群体中验证LSS,并证明LSS在改善患者结局方面的益处。