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1.河北医科大学第二医院鹿泉院区 药学部,石家庄 050200
2.河北医科大学第一医院临床药学部,石家庄 050031
3.河北省人工智能临床药学技术创新中心,石家庄 050031
主管药师,硕士研究生。研究方向:个体化治疗、抗抑郁药物研究。E-mail:359502111@qq.com
主任药师,博士生导师,博士。研究方向:个体化治疗、药物基因组学、临床药理学。E-mail:zhouchunhua@hebmu.edu.cn
收稿:2025-11-06,
修回:2026-02-13,
录用:2026-03-16,
纸质出版:2026-03-30
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张泽,赵梦强,于瑞妍,等.米氮平稳态谷浓度及剂量校正血药浓度的特征与影响因素分析 [J].中国药房,2026,37(06):776-781.
ZHANG Ze,ZHAO Mengqiang,YU Ruiyan,et al.Analysis of the characteristics and influencing factors of mirtazapine steady-state trough concentration and concentration-to-dose ratio[J].ZHONGGUO YAOFANG,2026,37(06):776-781.
张泽,赵梦强,于瑞妍,等.米氮平稳态谷浓度及剂量校正血药浓度的特征与影响因素分析 [J].中国药房,2026,37(06):776-781. DOI: 10.6039/j.issn.1001-0408.2026.06.14.
ZHANG Ze,ZHAO Mengqiang,YU Ruiyan,et al.Analysis of the characteristics and influencing factors of mirtazapine steady-state trough concentration and concentration-to-dose ratio[J].ZHONGGUO YAOFANG,2026,37(06):776-781. DOI: 10.6039/j.issn.1001-0408.2026.06.14.
目的
2
分析米氮平稳态谷浓度及剂量校正血药浓度(
C
/
D
)的分布特征,并探讨临床及遗传因素对
C
/
D
的影响。
方法
2
回顾性选择河北医科大学第一医院2022年5月至2025年5月接受米氮平治疗并完成治疗药物监测的抑郁症住院患者为研究对象。收集患者的性别、年龄、体重指数、日给药剂量、稳态谷浓度、吸烟状态、肝病史、药品类型、联合用药情况以及
CYP2D6
代谢表型等资料,并计算
C
/
D
;采用Spearman等级相关分析探究米氮平稳态谷浓度与日给药剂量的关系;采用单因素分析和多元线性回归模型筛选可能影响米氮平
C
/
D
的因素。
结果
2
共纳入226例患者,其米氮平日给药剂量为25.00(24.82,30.00)mg/d,稳态谷浓度为44.46(20.00,70.00)ng/mL,
C
/
D
为1.83(1.00,2.00)(ng·d)/(mL·mg)。121例患者(53.54%)的稳态谷浓度处于参考范围(30~80 ng/mL)内,80例(35.40%)低于参考范围下限,25例(11.06%)高于参考范围上限。米氮平稳态谷浓度与日给药剂量呈正相关(决定系数=0.320 8,
P
<0.001),性别、吸烟状态及
CYP2D6
代谢表型与米氮平
C
/
D
显著相关(
P
<0.05)。
结论
2
米氮平稳态谷浓度个体差异明显;性别、吸烟状态、
CYP2D6
代谢表型为米氮平
C
/
D
的独立影响因素,其中女性、不吸烟、中间代谢型患者的
C
/
D
更高。
OBJECTIVE
2
To analyze the distribution characteristics of mirtazapine steady-state trough concentration and concentration-to-dose ratio (
C
/
D
), and to investigate the influence of clinical and genetic factors on
C
/
D
.
METHODS
2
A retrospective study was conducted on hospitalized patients with depression who received mirtazapine treatment and underwent therapeutic drug monitoring at the First Hospital of Hebei Medical University from May 2022 to May 2025. The collected data included patients’ gender, age, body mass index, daily dose, steady-state trough concentration, smoking status, history of liver disease, drug type, concomitant medications, and
CYP2D6
metabolic phenotype. The
C
/
D
was calculated. Spearman rank correlation was used to analyze the relationship between mirtazapine steady-state trough concentration and daily dose. Univariate analysis and multiple linear regression model were employed to screen the factors potentially influencing the
C
/
D
of mirtazapine.
RESULTS
2
A total of 226 patients were included. The daily dose of mirtazapine was 25.00 (24.82, 30.00) mg/d, the steady-state trough concentration was 44.46 (20.00, 70.00) ng/mL, and the
C
/
D
was 1.83 (1.00, 2.00) (ng·d)/(mL·mg). Steady-state trough concentrations were within the reference range (30-80 ng/mL) in 121 patients (53.54%), below the lower limit in 80 patients (35.40%), and above the upper limit in 25 patients (11.06%). A positive correlation was observed between mirtazapine steady-state trough concentration and daily dose (coefficient of determination was 0.320 8,
P
<0.001). Gender, smoking status, and
CYP2D6
metabolic phenotype were significantly associated with the mirtazapine
C
/
D
(
P
<0.05).
CONCLUSIONS
2
Significant interindividual variability exists in mirtazapine steady-state trough concentrations. Gender, smoking status, and
CYP2D6
metabolic phenotype are identified as independent influencing factors for the mirtazapine
C
/
D
, with higher
C
/
D
ratios observed in females, non-smokers, and intermediate metabolizers.
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