Biso Letizia, Carli Marco, Kolachalam Shivakumar, Monticelli Giorgio, Calabrò Pasquale Fabio, di Paolo Antonello, Giorgi Filippo Sean, Bocci Guido, Scarselli Marco
Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56126 Pisa, Italy.
Aseptic Pharmacy, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London W6 8RF, UK.
Pharmaceuticals (Basel). 2023 Jun 29;16(7):945. doi: 10.3390/ph16070945.
Despite receiving appropriate antiseizure medications (ASMs), a relevant percentage of neuropsychiatric patients do not benefit from this approach, and one reason is subtherapeutic ASMs plasma concentration (C(p)) due to improper drug adherence, interindividual pharmacokinetic differences, or metabolic interactions among different drugs. For these reasons, therapeutic drug monitoring (TDM) by measuring ASMs C(p) is an effective tool that improves pharmacological therapies in clinical practice. Based on these premises, in the present real-world study, we analyzed the C(p) of the most used ASMs in diverse medical conditions, which were assayed during the years 2018-2022 at the University Hospital of Pisa, including about 24,000 samples. This population was largely heterogeneous, and our database did not contain clinical information about the patients. The most used ASMs were Valproate (VPA: 54.5%) and Levetiracetam (LEV: 18.6%), followed by Oxcarbazepine (OxCBZ: 8.3%) and Carbamazepine (CBZ: 7.2%), whereas the associations LEV/VPA, Ethosuximide (ESM)/VPA, and CBZ/VPA were the most frequently proposed. In about 2/3 of assays, ASMs C(p) was in range, except for VPA, which was underdosed in almost half of the samples. Importantly, toxic levels of ASMs C(p) were found very rarely. For VPA, there was a decrease of mean C(p) across ages, from adolescents to older patients, while the C(p) of LEV, CBZ, OxCBZ, and Topiramate (TPM) showed a slight tendency to increase. When we compared females and males, we found that for VPA, the average age was higher for females, whereas women taking Lamotrigine (LTG) and OxCBZ were younger than men. Then, comparing ASMs used in neurologic and psychiatric disorders, based on the request form, it emerged that the mean C(p) of CBZ, OxCBZ, and LTG on samples collected in the Psychiatric Unit was lower compared to the Neurology and Child Neuropsychiatry Units. Finally, the ASMs subjected to multiple dosing starting from an initial subtherapeutic C(p) increased their level at different time points within a year, reaching the reference range for some of them. In conclusion, the present study suggests that TDM is widely applied to monitor ASMs C(p), finding many of them within the reference range, as a demonstration of its utility in clinical practice.
尽管接受了适当的抗癫痫药物(ASMs)治疗,但仍有相当比例的神经精神疾病患者未从这种治疗方法中获益,其中一个原因是由于药物依从性差、个体间药代动力学差异或不同药物之间的代谢相互作用导致ASMs血浆浓度(C(p))低于治疗水平。基于这些原因,通过测量ASMs C(p)进行治疗药物监测(TDM)是一种有效的工具,可改善临床实践中的药物治疗。基于这些前提,在本项真实世界研究中,我们分析了2018年至2022年期间在比萨大学医院检测的各种医疗状况下最常用的ASMs的C(p),样本数量约为24,000份。该人群具有很大的异质性,并且我们的数据库不包含患者的临床信息。最常用的ASMs是丙戊酸盐(VPA:54.5%)和左乙拉西坦(LEV:18.6%),其次是奥卡西平(OxCBZ:8.3%)和卡马西平(CBZ:7.2%),而LEV/VPA、乙琥胺(ESM)/VPA和CBZ/VPA的联合用药是最常被提议的。在大约2/3的检测中,ASMs C(p)处于正常范围,但VPA除外,几乎一半的样本中其剂量不足。重要的是,很少发现ASMs C(p)达到中毒水平。对于VPA,从青少年到老年患者,平均C(p)随年龄增长而降低,而LEV、CBZ、OxCBZ和托吡酯(TPM)的C(p)则有轻微升高趋势。当我们比较女性和男性时,发现对于VPA,女性的平均年龄较高,而服用拉莫三嗪(LTG)和OxCBZ的女性比男性年轻。然后,根据申请表比较用于神经疾病和精神疾病的ASMs,结果显示,与神经内科和儿童神经精神科相比,精神科收集的样本中CBZ、OxCBZ和LTG的平均C(p)较低。最后,从初始低于治疗水平的C(p)开始多次给药的ASMs在一年内的不同时间点其水平有所升高,其中一些达到了参考范围。总之,本研究表明TDM被广泛应用于监测ASMs C(p),发现其中许多处于参考范围内,证明了其在临床实践中的实用性。