氨磺必利片治疗药物监测及临床应用研究

Research on therapeutic drug monitoring and clinical application of amisulpride tablets

目的分析氨磺必利的血药浓度与给药剂量、药物品种、性别、年龄和体重的相关性。方法用高效液相色谱-质谱联用法测定患者的氨磺必利血清谷浓度。回顾性查阅2016年至2017年我院1392例次住院患者氨磺必利的血药浓度监测记录,将浓度值、给药剂量、性别、年龄、厂家和合并用药等资料录入数据库,用SPSS 16. 0软件进行统计分析。结果成人患者服用氨磺必利后平均血药浓度为374. 75 ng·m L^(-1),明显高于现有指南的参考范围,提示指南现有范围可能不适用于研究人群。氨磺必利最常见的药物不良反应为轻至中度锥体外系反应。结论老年患者、合并给药(丙戊酸、奥美拉唑和雷贝拉唑)可显著增加剂量校正后氨磺必利血药浓度,建议从低剂量开始给药,并密切注意监测血药浓度,减少发生药物不良反应的概率。性别、<18岁、厂家对该药的血药浓度影响不明显。

Objective To investigate the relationships between dosage, type,gender, age, body weight and serum trough concentration of amisulpride.Methods A high performance liquid chromatography - mass spectrometry technology was used to detect the serum trough concentrations of amisulpride.The clinical information including amisulpride serum trough concentration,dosage,gender,age,manufacturers and concomitant medication of 1392 psychiatric inpatients treated with amisulpride were reviewed from 2016 to 2017,and then analyzed by SPSS 16.0 software retrospectively.Results The mean amisulpride concentration in adult patients in our study was 374.75 ng·mL^-1,far beyond the reference range in guidelines,suggesting current ranges could be inappropriate for the study population.The most common adverse effect of amisulpride was mild to moderate extrapyramidal reactions.Conclusion The elderly and co-medication with valproic acid,omeprazole and rabeprazolewere significantly increase dosage-adjust serum concentrations of amisulpride,indicating slow incremental dosage in these populations, while impacts of gender, age below 18 and manufactory were less important on the serum concentrations of amisulpride.