乡村医学 ›› 2025, Vol.2 ›› Issue (4) DOI: 10.12238/jrm.v2i4.14329

精神分裂症患者氨磺必利血药浓度范围：基于治疗药物监测的研究

田秘 , 党伟 (

) , 陈延明 , 丁靖 , 欧盼

1 . 西安医学院研究生处，西安市精神卫生中心
2 . 西安医学院研究生处，西安市精神卫生中心
3 . 西安市精神卫生中心
4 . 西安市精神卫生中心
5 . 西安市精神卫生中心

收稿日期:2025-04-01 07:57:56 发布日期:2025-07-16
通讯作者: 党伟
作者贡献：
基金资助:

Blood Concentration Range of Amisulpride in Patients with Schizophrenia: A Study Based on Therapeutic Drug Monitoring

TIAN Mi DANG Wei (

) CHEN Yanming DING Jing OU Pan

School of Graduate, Xi’an Medical University，Xi’an Mental Health Center
School of Graduate, Xi’an Medical University，Xi’an Mental Health Center
Xi’an Mental Health Center
Xi’an Mental Health Center
Xi’an Mental Health Center

Received:2025-04-01 07:57:56 Online:2025-07-16
Contact: DANG Wei

摘要/Abstract

摘要： 目的：分析探讨氨磺必利血药浓度的主要影响因素，制定氨磺必利治疗药物浓度参考范围，为中国精神分裂症患者群体的个体化用药提供参考。方法：回顾性收集并分析了 142 例接受氨磺必利片治疗的精神分裂症住院患者 TDM 结果及用药情况。利用单因素分析和多元线性回归分析氨磺必利血药浓度的影响因素；根据 PANSS 量表评分结果及减分率评估患者接受氨磺必利治疗的有效性。结果：共纳入 142 例患者，其氨磺必利血药浓度的中位数与血浆浓度 / 剂量比值（C/D）分别为 458.7ng/mL和 8.38。身体质量指数（Body mass index, BMI）与氨磺必利 C/D 值呈显著负相关（p ＜ 0.05），根据 BMI 将患者分群，在肥胖患者中（BMI ≥ 28kg/m² ），中老年患者的 C/D 值显著高于青年患者（p ＜ 0.05）；在超重患者（24kg/m² ≤ BMI ＜ 28kg/m² ）中，女性青年患者的 C/D 值显著高于男性青年患者（p ＜ 0.05）。ROC 分析表明，减分率达 50% 时氨磺必利血药浓度为487.8ng/mL。患者氨磺必利血药浓度与不良反应的相关性分析表明，血药浓度高于 487.8ng/mL 的患者群体中，均未出现肾功异常病例，且药物浓度和催乳素水平升高、心电图异常、肝功能异常等不良反应无显著相关性（p ＞ 0.05）。结论：本研究中，患者的氨磺必利血药浓度普遍高于指南推荐的药物监测浓度范围，BMI 是其 C/D 值的重要影响因素。当治疗有效率达 50% 时，氨磺必利血药浓度为 487.8ng/mL 并表现出良好的安全性，为制定适用于中国精神分裂症患者的氨磺必利血药浓度监测范围提供了重要参考。

关键词: 氨磺必利；血药浓度；BMI；治疗参考范围

Abstract

Objective: Analyze and explore the main influencing factors of blood concentration of amisulpride, establish a reference range for amisulpride treatment drug concentration, and provide reference for individualized medication of Chinese schizophrenia patients.Method: A retrospective collection and analysis were conducted on the TDM results and medication use of 142 hospitalized patients withschizophrenia who received treatment with amisulpride tablets. Using single factor analysis and multiple linear regression to analyze the influencing factors of blood concentration of amisulpride; Evaluate the effectiveness of patients receiving amisulpride treatment based on the PANSS scoring results and reduction rate.Result：A total of 142 patients were included, with a median blood concentration of amisulpride and a plasma concentration/dose ratio (C/D) of 458.7ng/mL and 8.38, respectively. The body mass index (BMI) is significantly negatively correlated with the C/D value of amisulpride (p<0.05). Patients were grouped according to BMI, and among obese patients (BMI ≥ 28kg/m²), the C/D value of middle-aged and elderly patients was significantly higher than that of young patients (p<0.05); In overweight patients (24kg/m² ≤ BMI<28kg/m²), the C/D value of female young patients is significantly higher than that of male young patients (p<0.05). ROC analysis showed that the blood concentration of amisulpride was 487.8ng/mL when the score reduction rate reached 50%. The correlation analysis between the blood concentration of amisulpride and adverse reactions in patients showed that there were no cases of renal dysfunction in the patient population with blood concentration higher than 487.8ng/mL, and there was no significant correlation between drug concentration and prolactin levels, abnormal electrocardiogram, liver function and other adverse reactions (p>0.05).Conclusion: In this study, the blood concentration of amisulpride in patients was generally higher than the recommended drug monitoring concentration range in the guidelines, and BMI was an important influencing factor on their C/D values. When the treatment efficacy reached 50%, the blood concentration of amisulpride was 487.8ng/mL and showed good safety, providing an important reference for developing a monitoring range of amisulpride blood concentration suitable for Chinese patients with schizophrenia.

Objective

Analyze and explore the main influencing factors of blood concentration of amisulpride, establish a reference range for amisulpride treatment drug concentration, and provide reference for individualized medication of Chinese schizophrenia patients.

Methods

A retrospective collection and analysis were conducted on the TDM results and medication use of 142 hospitalized patients with schizophrenia who received treatment with amisulpride tablets. Using single factor analysis and multiple linear regression to analyze the influencing factors of blood concentration of amisulpride; Evaluate the effectiveness of patients receiving amisulpride treatment based on the PANSS scoring results and reduction rate

Results

A total of 142 patients were included, with a median blood concentration of amisulpride and a plasma concentration/dose ratio (C/D) of 458.7ng/mL and 8.38, respectively. The body mass index (BMI) is significantly negatively correlated with the C/D value of amisulpride (p<0.05). Patients were grouped according to BMI, and among obese patients (BMI ≥ 28kg/m²), the C/D value of middle-aged and elderly patients was significantly higher than that of young patients (p<0.05); In overweight patients (24kg/m² ≤ BMI<28kg/m²), the C/D value of female young patients is significantly higher than that of male young patients (p<0.05). ROC analysis showed that the blood concentration of amisulpride was 487.8ng/mL when the score reduction rate reached 50%. The correlation analysis between the blood concentration of amisulpride and adverse reactions in patients showed that there were no cases of renal dysfunction in the patient population with blood concentration higher than 487.8ng/mL, and there was no significant correlation between drug concentration and prolactin levels, abnormal electrocardiogram, liver function and other adverse reactions (p>0.05).

Conclusion

In this study, the blood concentration of amisulpride in patients was generally higher than the recommended drug monitoring concentration range in the guidelines, and BMI was an important influencing factor on their C/D values. When the treatment efficacy reached 50%, the blood concentration of amisulpride was 487.8ng/mL and showed good safety, providing an important reference for developing a monitoring range of amisulpride blood concentration suitable for Chinese patients with schizophrenia.

Key words: Amisulpride；Plasma concentration；BMI；Treatment reference range

田秘,党伟,陈延明,丁靖,欧盼. 精神分裂症患者氨磺必利血药浓度范围：基于治疗药物监测的研究[J]. 乡村医学, . DOI: 10.12238/jrm.v2i4.14329.
TIAN Mi,DANG Wei,CHEN Yanming,DING Jing,OU Pan. Blood Concentration Range of Amisulpride in Patients with Schizophrenia: A Study Based on Therapeutic Drug Monitoring[J]. 乡村医学, . DOI: 10.12238/jrm.v2i4.14329.

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精神分裂症患者氨磺必利血药浓度范围：基于治疗药物监测的研究

Blood Concentration Range of Amisulpride in Patients with Schizophrenia: A Study Based on Therapeutic Drug Monitoring

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