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癫痫或双相情感障碍患者抗癫痫药物血药浓度监测及其影响因素分析
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| 篇名： | 癫痫或双相情感障碍患者抗癫痫药物血药浓度监测及其影响因素分析 |
| TITLE： | Therapeutic drug monitoring of antiepileptic drugs and analysis of its influencing factors in patients with epilepsy or bipolar affective disorder |
| 摘要： | 目的 为癫痫或双相情感障碍患者抗癫痫药物（AEDs）的个体化使用提供参考。方法回顾性收集2023年1月－2025年12月于西安国际医学中心医院接受AEDs治疗并进行治疗药物监测（TDM）的癫痫或双相情感障碍患者的临床资料，汇总其基本信息、AEDs使用特征、TDM实施现状和实验室指标，采用Spearman相关性分析、单因素分析和多元线性回归分析筛选AEDs血药浓度的独立影响因素。结果共纳入1572例患者，男性660例、女性912例；以≥60岁居多（占30.15%）；71.76%的患者单用AEDs，且以丙戊酸最多（占51.97%）；联合用药以二联方案为主（占26.21%），少见三联方案（占2.04%）。共收集患者血药浓度检测样本2901个，其中丙戊酸、左乙拉西坦的检测样本（1987、684个）较多。5种药物的TDM检测均以1次为主，其中丙戊酸、左乙拉西坦使用者的血药浓度达标率均超过50%，拉莫三嗪、奥卡西平、卡马西平使用者的中位血药浓度均低于治疗参考浓度范围下限。综合Spearman相关性分析、单因素分析和多元线性回归分析结果可知，患者性别、血小板计数（PLT）、丙氨酸转氨酶（ALT）、天冬氨酸转氨酶（AST）、总胆红素（TBil）是丙戊酸血药浓度的独立影响因素（非标准化系数分别为－6.7707、－0.0786、－0.0994、0.0832、－0.5789，P＜0.05），年龄、血肌酐（CRE）是左乙拉西坦血药浓度的独立影响因素（非标准化系数分别为0.1087、0.0478，P＜0.05）。结论女性、AST偏高是丙戊酸血药浓度升高的危险因素，PLT、ALT、TBil水平升高则与丙戊酸血药浓度降低有关；老年及肾功能不全患者体内左乙拉西坦蓄积的风险较高。 |
| ABSTRACT： | OBJECTIVE To provide guidance for the individualized use of antiepileptic drugs （AEDs） in patients with epilepsy or bipolar affective disorder.METHODS Clinical data of patients with epilepsy or bipolar affective disorder who received AEDs treatment and underwent therapeutic drug monitoring （TDM） at Xi’an International Medical Center Hospital from January 2023 to December 2025 were retrospectively collected. The baseline information， characteristics of AEDs utilization， implementation status of TDM and laboratory parameters were summarized. Spearman correlation analysis， univariate analysis and multivariate linear regression analysis were performed to identify the independent influencing factors for blood concentrations of AEDs.RESULTS A total of 1 572 patients were enrolled， including 660 males and 912 females. The majority were aged ≥60 years （30.15%）； 71.76% of patients were on monotherapy with AEDs， with valproic acid being the most commonly prescribed （51.97%）； combination therapy was predominantly a two-drug regimen （26.21%）， while three-drug regimens were rare （2.04%）. A total of 2 901 blood samples for TDM were collected， with the highest number of samples for valproic acid and levetiracetam （1 987 and 684 samples， respectively）. TDM for all five drugs was primarily conducted once； among which， the blood concentrations attainment rates exceeded 50% for patients taking valproic acid and levetiracetam， while the median blood concentrations for patients taking lamotrigine， oxcarbazepine， and carbamazepine were all below the lower limit of the therapeutic reference range. Based on the results of Spearman correlation analysis， univariate analysis， and multivariate linear regression analysis， patient gender， platelet count （PLT）， alanine transaminase （ALT）， aspartate transaminase （AST）， and total bilirubin （TBil） were found to be independent factors influencing blood concentration of valproic acid （unstandardized coefficients were －6.770 7， －0.078 6， －0.099 4， 0.083 2， －0.578 9， P ＜0.05）， while age and creatinine （CRE） were found to be independent factors influencing blood concentration of levetiracetam （unstandardized coefficients were 0.108 7， 0.047 8， P ＜0.05）.CONCLUSIONS Female gender and elevated AST levels are risk factors for increased blood concentration of valproic acid， while elevated PLT， ALT and TBil levels are associated with decreased blood concentration of valproic acid. Patients of advanced age and those with renal insufficiency bear a relatively high risk of in vivo levetiracetam accumulation. |
| 期刊： | 2026年第37卷第18期 |
| 作者： | 袁海玲；田春艳；陈曦；苏怡；张云松；张玉；徐丽婷 |
| AUTHORS： | YUAN Hailing，TIAN Chunyan，CHEN Xi，SU Yi，ZHANG Yunsong，ZHANG Yu，XU Liting |
| 关键字： | 抗癫痫药物;治疗药物监测;癫痫;双相情感障碍;影响因素;丙戊酸;左乙拉西坦 |
| KEYWORDS： | Antiepileptic drugs;Therapeutic drug monitoring;Epilepsy;bipolar affective disorder;Influencing factors;Valproic acid;Levetiracetam |
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