中国药物警戒 ›› 2025, Vol. 22 ›› Issue (4): 420-423.
DOI: 10.19803/j.1672-8629.20240825

• 安全与合理用药 • 上一篇    下一篇

舒必利稳态谷浓度/剂量比及常见不良反应的影响因素分析

兰晓倩1,2, 果伟1,2,*   

  1. 1首都医科大学附属北京安定医院药事部,国家精神心理疾病临床医学研究中心,精神疾病诊断与治疗北京市重点实验室,北京 100088;
    2首都医科大学人脑保护高精尖创新中心,北京 100069
  • 收稿日期:2024-10-24 发布日期:2025-04-17
  • 通讯作者: *果伟,男,硕士,主任药师,精神药理学。E-mail: guowe@ccmu.edu.cn
  • 作者简介:兰晓倩,女,硕士,主管药师,临床药学。
  • 基金资助:
    首都卫生发展科研专项（首发2020-1-2031）; 首都医科大学附属北京安定医院院级基金课题（YJ201903）

Trough Steady-State Concentration/Dose Ratio and Contributors to Adverse Drug Reactions of Sulpiride

LAN Xiaoqian1,2, GUO Wei1,2,*   

  1. 1Department of Pharmacy, Beijing Anding Hospital Affiliated to Capital Medical University, National Medical Research Center for Mental Disorders &Beijing Key Laboratory for Diagnosis and Treatment of Mental Disorders, Beijing 100088, China;
    2Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing 100069, China
  • Received:2024-10-24 Published:2025-04-17

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摘要： 目的 研究舒必利稳态谷浓度/剂量比（Cmin/D）的影响因素,并探索舒必利引起锥体外系反应（EPS）和高泌乳素血症（HPRL）的危险因素,促进舒必利个体化合理用药。方法 纳入首都医科大学附属北京安定医院2018年9月1日至2023年2月28日接受治疗药物监测（TDM）的住院患者,通过电子病历系统收集其性别、年龄、体质量指数（BMI）、吸烟史、血清肌酐值等基本资料,及给药剂量、合并用药、不良反应等药物治疗信息,通过SPSS 26.0软件进行数据统计分析。结果 共纳入TDM测得稳态血药浓度患者113例,服药剂量为0.4（0.3,0.8）g·d-1,采血时间校正后的舒必利稳态谷浓度（Cmin）为374.80（210.64,656.58）ng·mL-1,Cmin/D值范围为0.83（0.59,1.10） ng·mL-1·mg-1·d;多重线性回归提示不同年龄和性别患者Cmin/D值的差异具有统计学意义（P<0.05）。患者服药后不良反应发生率最高的是HPRL和EPS;合并三环类抗抑郁药（TCAs）/5-羟色胺再摄取抑制剂（SSRI）与未合并组舒必利用药后出现EPS的差异具有统计学意义（P<0.05）;性别是服用舒必利后出现HPRL的危险因素（P<0.05）。结论 舒必利的稳态谷浓度与剂量相关,女性Cmin/D低于男性,未成年人Cmin/D低于成年人和老年人;舒必利与TCAs/SSRIs合并给药时应注意EPS风险,女性患者服用舒必利应密切关注催乳素水平。

关键词: 舒必利, 治疗药物监测, 稳态谷浓度, 剂量, 锥体外系反应, 高泌乳素血症, 危险因素

Abstract: Objectives To identify the determinants of the trough steady-state concentration/dose ratio (Cmin/D) of sulpiride, and detect the risk factors for hyperprolactinemia(HPRL) as well as extra pyramidal symptoms (EPS) after sulpiride administration based on therapeutic drug monitoring(TDM). Methods Hospitalized patients who underwent TDM in Beijing Anding Hospital between September 1, 2018 and February 28, 2023 were included. Such basic information as gender, age, body mass index (BMI), history of smoking and serum creatine levels was retrieved from the medical record system. Data on dosage, comedication and adverse drug reactions was also recorded. SPSS 26.0 was used for statistical analysis. Results One hundred and thirteen patients with steady-state concentrations determined by TDM were included. The daily dosage of sulpiride was 0.4 (0.3, 0.8) g·d-1, trough steady-state concentration (Cmin) 374.80 (210.64, 656.58) ng·mL-1,and the trough steady-state concentration/dose ratio (Cmin/D) was 0.83 (0.59, 1.10) ng·mL-1·mg-1·d. Multiple linear regression analysis suggested that gender and age had significant effects on Cmin/D (P<0.05). The most common adverse reactions were HPRL and EPS. The combination of TCAs/SSRIs increased the risk of EPS (P<0.05), and gender was identified as a risk factor for HPRL(P<0.05). Conclusion The Cmin of sulpiride is dose related, and Cmin/D is higher among females than among males, and higher among minors than among adults and geriatric patients. Concomitant use of TCAs/SSRIs with sulpiride requires caution due to the EPS risk, and prolactin levels should be closely monitored when sulpiride is administered to female patients.

Key words: Sulpiride, Therapeutic Drug Monitoring (TDM), Trough Steady-State Concentration, Dose, Extra Pyramidal Symptoms (EPS), Hyperprolactinemia (HPRL), Risk Factors

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