精神分裂症患者氨磺必利血药浓度治疗参考范围的真实世界数据研究  

A real-world study on the reference interval of plasma concentration of amisulpride for treating schizophrenia

作　　者：甘桐营 刘畅[1,2] 李琳 李璐 GAN Tongying;LIU Chang;LI Lin;LI Lu(Department of Pharmacy,The Affiliated Brain Hospital of Guangzhou Medical University,Guangdong Guangzhou 510000,China;Guangdong Provincial Key Laboratory of Neuroscience Disease Research&.Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China,Guangzhou Medical University,Guangdong Guangzhou 510000,China;Department of Clinical Pharmacy,The First Affiliated Hospital,Zhejiang University School of Medicine,Zhejang Hangzhou 310003,China;Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research,Zhejiang Hangzhou 310003,China)

机构地区：[1]广州医科大学附属脑科医院药剂科,广东广州510000 [2]广东省神经科学疾病研究重点实验室/神经致病基因与离子通道病省部共建重点实验室,广东广州510000 [3]浙江大学医学院附属第一医院临床药学部,浙江杭州310003 [4]浙江省药物临床研究与评价技术重点实验室,浙江杭州310003

出　　处：《中国医院药学杂志》2025年第4期427-432,438,共7页Chinese Journal of Hospital Pharmacy

基　　金：广州市基础研究计划市校(院)企联合资助项目(编号:2023A03J0441);广州市医学重点科学(2025-2027)。

摘　　要：目的:基于临床总体印象(clinical global impression,CGI)量表疗效评分和不良反应评估,收集出院医嘱治疗药物监测(therapeutic drug monitoring,TDM)数据,验证提高氨磺必利血药浓度治疗参考范围(320~600 ng·mL^(-1))在真实临床应用中的合理性。方法:回顾分析2022年1月至2023年12月广州医科大学附属脑科医院精神分裂症患者氨磺必利TDM结果及剂量调整情况,比较调整前后血药浓度变化及与出院医嘱TDM结果的差异。结果:共纳入430例患者(103例中途停药、327例出院带药)TDM数据,其中269例患者氨磺必利出院医嘱TDM结果为(390.17±246.01) ng·mL^(-1),仅40.52%血药浓度集中在神经精神药理学与药物精神病学协会(Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie,AGNP)指南治疗参考范围(100~320 ng·mL^(-1))内,而100~600 ng·mL^(-1)范围内血药浓度占76.21%。70例用药调整后复查TDM结果在320~600 ng·mL^(-1)区间增加14.29%,剂量增加组(n=35)在>320 ng·mL^(-1)区间有最大增幅(28.57%),减小组(n=34)在>600 ng·mL^(-1)区间有最大降幅(29.41%)。结论:在真实世界临床应用中,氨磺必利血药浓度在320~600 ng·mL^(-1)范围有良好的有效性和安全性,进一步验证了氨磺必利100~600 ng·mL^(-1)的血药浓度参考范围存在的合理性。OBJECTIVE To validate the rationality of increasing the reference interval of plasma amisulpride(320-600 ng·mL^(-1))in real clinical applications for treating schizophrenia by analyzing the efficacy score and adverse events via the clinical global impression(CGI)and the Therapeutic Drug Monitoring(TDM)data at discharge.METHODS TDM results and dose adjustments of amisulpride in schizophrenia patients from January 2022 to December 2023 in The Affiliated Brain Hospital of Guangzhou Medical University were retrospectively analyzed.Plasma concentrations of amisulpride and TDM results at discharge before and after adjustments were compared.RESULTS TDM data of 430 patients(103 cases of withdrawal during the treatment,and 327 cases of discharged with medication)were included.Among them,269 schizophrenia patients had the plasma amisulpride concentration of(390.17±246.01)ng·mL^(-1) recorded in the TDM data at discharge,with only 40.52%of the plasma concentration concentrated in the therapeutic reference range(100-320 ng·mL^(-1))recommended by the Arbeitsgemeinschaft fur Neuropsychopharmakologie und Pharmakopsychiatrie(AGNP).76.21%of patients had the plasma amisulpride concentration ranged at 100-600 ng·mL^(-1)1.After medication adjustment,70 cases showed a significant increase of 14.29%in TDM within the range of 320-600 ng·mL^(-1),with the increase group(n=35)having the greatest increase of 28.57%in the>320 ng·mL^(-1)range and the decrease group(n=34)having the greatest decrease of 29.41%in the>600 ng·mL^(-1)range.CONCLUSION In real-world clinical applications,plasma amisulpride concentration ranged 320-600 ng·mL^(-1)is efficacy and safe.Our data further validate the rationale for the reference range of 100-600 ng·mL^(-1)of plasma amisulpride concentrations for treating schizophrenia.

关 键 词：氨磺必利 血药浓度 治疗药物监测 治疗参考范围 

分 类 号：R971.411[医药卫生—药品]