喹硫平药物浓度监测及临床参考值范围的初步建立  

Preliminary exploration on reference range of serum quetiapine fumarate concentration

作　　者：刘红梅[1] 林治光[1] 任娟娟[1] 崔慧茹[1] 蒋平[1] 朱怡康 孙秀佳[1] 李春波[1] 

机构地区：[1]上海交通大学医学院附属精神卫生中心,上海200030

出　　处：《世界临床药物》2012年第10期612-615,共4页World Clinical Drug

基　　金：国家自然科学基金项目(81071098);"重大新药创制"科技重大专项:精神药物新药临床评价研究技术平台(2012ZX09303-003);上海交通大学科技创新发展专项资金-重点项目;上海市精神卫生中心院级课题(2011-YJ-14)

摘　　要：目的建立大样本喹硫平血药浓度临床参考值范围,并探讨相关影响因素。方法收集口服喹硫平治疗2周以上的住院病例(2 246例)血样,以反相高效液相色谱(RP-HPLC)技术测定样本喹硫平血药浓度,采用SPSS17.0软件对部分因素做相关性分析。结果血药浓度数据分析显示,不同年龄、性别间的喹硫平血药浓度差异无统计学意义;与阿立哌唑、奥氮平、利培酮、氯丙嗪和氯氮平等常见抗精神病药物联用时,喹硫平血药浓度变化也无统计学意义。多因素方差分析显示,口服剂量是喹硫平血药浓度的主要影响因素。本研究总样本喹硫平血药浓度的临床参考值范围为(32.0～525.5)ng/mL。结论常规剂量下喹硫平血药浓度临床参考值范围为(32.0～525.5)ng/mL,且血药浓度与剂量有一定关联,而年龄、性别以及联合用药等因素的影响尚需待进一步评价。Objective To establish the reference range of quetiapine fumarate concentration in serum by monitoring a large quantity of patients, and to investigate some related factors. Methods A total of 2 246 patients administrated by oral quetiapine fumarate for at least two weeks were collected. The quetiapine concentration in serum was determined by reverse phase high-performance liquid chromatography （RP-HPLC）. Data were analyzed by SPSS 17.0 software. Results The drug concentrations in serum were not significantly different between male and female, as well as individuals aged 18 to 60 years and those aged 〉60 years. Co-medicated with aripiprazole, olanzapine, risperidone, chlorpromazine and clozapine did not significantly change the serum quetiapine fumarate concentrations. Multivariate tests showed that serum drug concentration was related to dose. The reference range of total samples （2.5%-97.5%） was （32.0-525.5） ng/mL. Conclusion The reference range of quetiapine fumarate concentration in serum is not significantly related to age, gender and co-medication but dose.

关 键 词：富马酸喹硫平 治疗药物监测(TDM) 参考值范围 

分 类 号：R971.41[医药卫生—药品] R969.1[医药卫生—药学]