Qu Kankan, Zhou Qin, Tian Lin, Shen Yuan, Zhou Zhenhe
The Affiliated Wuxi Mental Health Center of JiangNan University, Wuxi Tongren Rehabilitation Hospital, Wuxi, Jiangsu, China.
Int Clin Psychopharmacol. 2022 Nov 1;37(6):255-262. doi: 10.1097/YIC.0000000000000420. Epub 2022 Jun 27.
The aim of the study was to evaluate the reference range of amisulpride for Chinese patients with schizophrenia and to assess its possible influencing factors based on therapeutic drug monitoring information. The relative adverse reactions of patients induced by amisulpride were also systematically investigated. A total of 425 patients with schizophrenia were assessed, including Positive and Negative Syndrome Scales, Treatment Emergent Symptom Scale, blood routine examination, hepatorenal function, lipids, hormones, as well as myocardial enzymes at baseline, and following treatment with amisulpride for 8 weeks. The steady-state plasma concentration of amisulpride was assayed using two-dimensional liquid chromatography. At the same dose, the amisulpride plasma concentration of patients combined with clozapine was higher than that without clozapine. The therapeutic reference range of amisulpride can be defined as 230.3-527.1 ng/ml for Chinese patients with schizophrenia. The potential side effects appear to be associated with significantly increased levels of LDH, CK, creatine kinase isoenzyme (CK-MB), TC and decreased level of E 2 , relative to the amisulpride plasma concentration. These findings could provide individualized medication and reduce the adverse effects of amisulpride for Chinese patients with schizophrenia.
本研究旨在评估氨磺必利在中国精神分裂症患者中的参考范围，并根据治疗药物监测信息评估其可能的影响因素。还系统地调查了氨磺必利引起的患者相对不良反应。共评估了425例精神分裂症患者，包括在基线时以及使用氨磺必利治疗8周后进行阳性和阴性症状量表、治疗中出现的症状量表、血常规检查、肝肾功能、血脂、激素以及心肌酶检查。采用二维液相色谱法测定氨磺必利的稳态血浆浓度。在相同剂量下，联合氯氮平的患者氨磺必利血浆浓度高于未联合氯氮平的患者。中国精神分裂症患者氨磺必利的治疗参考范围可定义为230.3 - 527.1 ng/ml。相对于氨磺必利血浆浓度，潜在的副作用似乎与乳酸脱氢酶（LDH）、肌酸激酶（CK）、肌酸激酶同工酶（CK - MB）、总胆固醇（TC）水平显著升高以及雌二醇（E2）水平降低有关。这些发现可为中国精神分裂症患者提供个体化用药并减少氨磺必利的不良反应。
