喹硫平药物浓度监测及临床参考值范围的初步建立

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、氯丙嗪和氯氮甲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,口服剂量是喹硫甲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.

Preliminary exploration on reference range of serum quetiapine fumarate concentration

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.