Chen Xiao, Hu Ke, Shi Hao-Zhe, He Su-Mei, Yang Yang, Yang Chao-Wen, Zhang Yue, Tian Xue, Li Ye, Gao Yu-Hang, Xu Wen-Yi, Zhang Cun, Wang Dong-Dong
School of Nursing, Xuzhou Medical University, Xuzhou, Jiangsu, China.
Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy and School of Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu, China.
Front Pharmacol. 2025 Jan 7;15:1470865. doi: 10.3389/fphar.2024.1470865. eCollection 2024.
The present study aims to explore the initial dosage optimization of sertraline in pediatric major depressive disorder (MDD) patients based on model-informed precision dosing (MIPD).
A total of 111 pediatric MDD patients treated with sertraline were included for analysis using MIPD. Sertraline concentration levels, physiological and biochemical indexes of pediatric MDD patients, combined drug information were included in the construction of model.
Weight and zopiclone co-administration influenced sertraline clearance in pediatric MDD patients. With the same weight, the sertraline clearance rates were 0.453:1 in patients with, or without zopiclone, respectively. Furthermore, without zopiclone, for once-daily sertraline scheme, the dosages of 4.0, and 3.0 mg/kg/day were suggested for pediatric MDD patients with body weight of 30-38.5, and 38.5-80 kg, respectively; for twice-daily sertraline scheme, the dosage of 2.0 mg/kg/day was suggested for pediatric MDD patients with body weight of 30-80 kg. With zopiclone, for once-daily sertraline scheme, the dosage of 1.0 mg/kg/day was suggested for pediatric MDD patients with body weight of 30-80 kg; for twice-daily sertraline scheme, the dosage of 0.5 mg/kg/day was suggested for pediatric MDD patients with body weight of 30-80 kg.
This study first explored the initial dosage optimization of sertraline in pediatric MDD patients based on MIPD, and recommended the optimal sertraline initial dosage in pediatric MDD patients based on zopiclone co-administration.
本研究旨在基于模型引导的精准给药(MIPD)探索舍曲林在儿童重度抑郁症(MDD)患者中的初始剂量优化。
共纳入111例接受舍曲林治疗的儿童MDD患者,采用MIPD进行分析。构建模型时纳入了儿童MDD患者的舍曲林浓度水平、生理生化指标及联合用药信息。
体重和佐匹克隆联合使用影响儿童MDD患者舍曲林的清除率。在相同体重下,使用或未使用佐匹克隆的患者舍曲林清除率分别为0.453:1。此外,未使用佐匹克隆时,对于每日一次舍曲林给药方案,体重30 - 38.5 kg和38.5 - 80 kg的儿童MDD患者建议剂量分别为4.0和3.0 mg/kg/天;对于每日两次舍曲林给药方案,体重30 - 80 kg的儿童MDD患者建议剂量为2.0 mg/kg/天。使用佐匹克隆时,对于每日一次舍曲林给药方案,体重30 - 80 kg的儿童MDD患者建议剂量为1.0 mg/kg/天;对于每日两次舍曲林给药方案,体重30 - 80 kg的儿童MDD患者建议剂量为0.5 mg/kg/天。
本研究首次基于MIPD探索了儿童MDD患者舍曲林的初始剂量优化,并根据佐匹克隆联合使用情况推荐了儿童MDD患者舍曲林的最佳初始剂量。