Patrick Morgan, Parmiter Samuel, Mahmoud Sherif Hanafy
Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, 3-142H Katz Group Centre for Pharmacy and Health Research, Edmonton, AB, T6G 2E1, Canada.
Eur J Drug Metab Pharmacokinet. 2021 Mar;46(2):205-223. doi: 10.1007/s13318-020-00661-1.
Therapeutic drug monitoring (TDM) of antiepileptic drugs (AED) using blood is well established but limited by its invasiveness, accessibility, cost, interpretation errors, and related disturbances in protein binding. TDM using oral fluid (OF) could overcome these limitations. This paper provides a summary of the current evidence for using OF as a matrix to perform TDM of AEDs, as well as practical considerations. A literature search of MEDLINE, EMBASE, and the Cochrane Library was conducted on April 9, 2018 (and then updated on May 20, 2020) using all AEDs as keywords along with "oral fluid," "saliva," "salivary," "seizure," "epilepsy," "antiepileptic," and "anticonvulsant." A total of 18 relevant articles were found and included in this review. There is evidence to suggest that AED TDM using OF is feasible and that reference ranges can be calculated for the following drugs: carbamazepine, ethosuximide, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, primidone, topiramate, and valproic acid. For all other AEDs, there is either a lack of evidence on the feasibility of TDM using OF or the evidence indicates that TDM using OF is not feasible. Practical considerations should include the timing and method of OF collection (stimulated or unstimulated) due to their probable impact on the reliability of AED TDM. Using OF may improve the acceptability and accessibility and reduce the cost of AED TDM. Clinical implementation requires standardized collection protocols, more rigorously defined OF reference ranges, and further studies to determine the relevance to clinically important outcomes.
使用血液对抗癫痫药物(AED)进行治疗药物监测(TDM)已得到广泛应用,但受到其侵入性、可及性、成本、解释误差以及蛋白质结合相关干扰的限制。使用口腔液(OF)进行TDM可以克服这些限制。本文总结了目前将OF作为基质进行AED TDM的证据以及实际考虑因素。2018年4月9日对MEDLINE、EMBASE和Cochrane图书馆进行了文献检索(并于2020年5月20日更新),使用所有AED作为关键词,同时加入“口腔液”“唾液”“唾液的”“癫痫发作”“癫痫”“抗癫痫的”和“抗惊厥的”。共找到18篇相关文章并纳入本综述。有证据表明,使用OF进行AED TDM是可行的,并且可以为以下药物计算参考范围:卡马西平、乙琥胺、拉科酰胺、拉莫三嗪、左乙拉西坦、奥卡西平、苯巴比妥、苯妥英、扑米酮、托吡酯和丙戊酸。对于所有其他AED,要么缺乏使用OF进行TDM可行性的证据,要么证据表明使用OF进行TDM不可行。实际考虑因素应包括OF采集的时间和方法(刺激或未刺激),因为它们可能会影响AED TDM的可靠性。使用OF可能会提高可接受性和可及性,并降低AED TDM的成本。临床实施需要标准化的采集方案、更严格定义的OF参考范围,以及进一步的研究来确定其与临床重要结果的相关性。