基于药动/药效学建模与模拟的中枢镇静类儿科用药研究进展  

Advances in pediatric drug for central sedation based on pharmacokinetic/pharmacodynamic modeling and simulation

作　　者：朱金颖 周素凤 王璐 许明哲[3] 邵凤 ZHU Jinying;ZHOU Sufeng;WANG Lu;XU Mingzhe;SHAO Feng(Phase I Clinical Trial Unit,The First Affiliated Hospital of Nanjing Medical University,Nanjing Jiangsu 210029,China;School of Pharmacy,Nanjing Medical University,Nanjing Jiangsu 211166,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]南京医科大学第一附属医院Ⅰ期临床试验研究室,江苏南京210029 [2]南京医科大学药学院,江苏南京211166 [3]中国食品药品检定研究院,北京102629

出　　处：《中国药物警戒》2022年第7期721-727,共7页Chinese Journal of Pharmacovigilance

基　　金：重大新药创制国家科技重大专项2017年度(2017ZX09101001)。

摘　　要：目的 对中枢镇静类儿科药物的药动/药效学(PK/PD)模型进行综述,为定量药理学模型在儿科药物研发上提供参考。方法 对近20年中枢镇静类儿科药物定量药理学相关文献进行整理、分析、归纳。结果 清除率是确定不同年龄段的儿科人群用药剂量的重要参数,也是PK/PD模型模拟的关键拟合参数,且清除率变化与儿科人群的体重变化呈现良好的相关性。结论 儿科患者具有明显的发育学特征,尤其在作用于中枢系统的药物上需要更密切地关注。基于儿科人群与成人之间的生理药动学差异、药物暴露-效应差异以及儿科人群临床试验的实施特点,PK/PD模型有助于儿科患者个体化治疗。Objective To summarize the pharmacokinetic/pharmacodynamic(PK/PD) models of central sedative pediatric drugs in order to provide references for quantitative pharmacological models in pediatric drug research and development.Methods The related literature of quantitative pharmacology of central sedative pediatric drugs were collected,analyzed,and summarized in the recent 20 years.Results Clearance was a key parameter to fit the PK/PD models,so it could be critical for determining the doses for pediatrics at different ages.Moreover,there was also a good correlation between the clearance and body weight in pediatric population.Conclusion A close attention should be paid on the physiological characteristics of pediatric patients,especially for investigating drugs acting on the central nervous system.Based on the physiological pharmacokinetic differences and drug exposure-response differences between pediatrics and adults,and considering the practice points of pediatric clinical trials,the PK/PD model supports the pediatric individualized treatment with central sedation drugs.

关 键 词：儿科人群 药动/药效学模型 数据外推 中枢镇静 剂量方案 个体化治疗 

分 类 号：R916.62[医药卫生—药学]