Article(id=1309634592252981342, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634582362809158, articleNumber=null, orderNo=null, doi=10.12048/j.issn.1674-229X.2026.04.009, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1748275200000, receivedDateStr=2025-05-27, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1790170818626, onlineDateStr=2026-09-23, pubDate=1777046400000, pubDateStr=2026-04-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1790170818626, onlineIssueDateStr=2026-09-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1790170818626, creator=13701087609, updateTime=1790170818626, updator=13701087609, issue=Issue{id=1309634582362809158, tenantId=1146029695717560320, journalId=1227999776411738115, year='2026', volume='36', issue='4', pageStart='241', pageEnd='320', issueExtLink='null', onlineDate='null', pubDate='1777046400000', pubDateStr='2026-04-25', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1790170816268, creator='13701087609', updateTime=1790219015105, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1309836742979576497, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634582362809158, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1309836742979576498, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634582362809158, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=299, endPage=307, ext={EN=ArticleExt(id=1309634592429142111, articleId=1309634592252981342, tenantId=1146029695717560320, journalId=1227999776411738115, language=EN, title=Model-informed Precision Dosing of Aripiprazole in Chinese Patients With Schizophrenia in Clinical Practice, columnId=null, journalTitle=Pharmacy Today, columnName=null, runingTitle=null, highlight=null, articleAbstract=
OBJECTIVE

To establish a new pathway for the external validation of population pharmacokinetics (PPK) models based on real-world data, using aripiprazole in the treatment of schizophrenia as an example, and to explore a novel strategy for the clinical application of model-informed precision dosing (MIPD) and its feasibility.

METHODS

A total of 101 patients with schizophrenia (1 178 blood drug concentration samples) were retrospectively enrolled at a class Ⅲ Grade A specialized hospital. Published PPK models of aripiprazole were identified by searching PubMed, Web of Science, and China National Knowledge Infrastructure (CNKI). Candidate models were evaluated using goodness-of-fit (R2) prediction error tests (PE, RPE%) to assess their predictive performance, and the model consistent with the characteristics of the blood concentration data was screened. Based on the selected PPK model, Monte Carlo simulation was performed to predict the steady-state plasma concentration of aripiprazole under different dosing regimens for individualized medication.

RESULTS

Three published PPK models of aripiprazole were included in this study. Goodness-of- fit and prediction error analyses showed that Model 3 had the best predictive performance. Based on Monte Carlo simulations with Model 3, plasma concentrations under 10 mg qd, 20 mg qd, and 30 mg qd regimens were ranked as IM > EM >UM in patients with the same body weight. For patients with the same CYP2D6 metabolic phenotype, plasma concentrations decreased with increasing body weight: 30 kg > 50 kg > 70 kg > 90 kg > 110 kg.

CONCLUSION

After validation with real-world data, the screened model with satisfactory predictive performance can be directly used in clinical practice to guide individualized medication and achieve model-informed precision dosing.

, authors=Shuyan ZENG1, 2, Wanting HUANG1, 2, Hui XIA1, 2, Zhihao GUO1, 2, Shanqing HUANG1, 3, Dewei SHANG1, 3, *, authorsList=Shuyan ZENG, Wanting HUANG, Hui XIA, Zhihao GUO, Shanqing HUANG, Dewei SHANG, authorCompany=null, correspAuthors=Dewei SHANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1309634592848572512, articleId=1309634592252981342, tenantId=1146029695717560320, journalId=1227999776411738115, language=CN, title=模型引导的阿立哌唑精准用药在中国精神分裂症患者的临床实践, columnId=1228268588277105398, journalTitle=今日药学, columnName=临床药学, runingTitle=null, highlight=null, articleAbstract=
目的

基于真实世界数据反向验证群体药代动力学(Population pharmacokinetics, PPK)模型的新路径,以阿立哌唑治疗精神分裂症为例,探索模型引导的精准用药(Model-informed precision dosing, MIPD)临床应用的新方法及可行性。

方法

回顾性纳入某三甲专科医院101例精神分裂症患者(1178个血药浓度点),利用PubMed、Web of Science、中国国家知识基础设施(China National Knowledge Infrastructure, CNKI)检索已发表的阿立哌唑PPK模型,通过拟合优度法(R2)和预测误差检验(PE、RPE%)对候选模型进行评价,评估已发表的PPK模型的预测性能,筛选得到符合血药浓度数据特征的模型。基于该PPK模型,应用蒙特卡洛模拟法仿真不同用药方案下阿立哌唑的稳态血药浓度范围,探索个体化用药。

结果

本研究共收集到3篇已发表的阿立哌唑的PPK模型。通过拟合优度法、预测误差检验发现,模型3最终模型的预测能力最佳。基于模型3采用蒙特卡洛模拟不同给药方案后的结果表明,10 mg qd、20 mg qd、30 mg qd方案下,相同体重患者的血药浓度:IM > EM > UM,相同CYP2D6代谢型患者的血药浓度:30 kg > 50 kg > 70 kg > 90 kg > 110 kg。

结论

通过真实世界数据的验证,在模型预测性能较为理想的情况下,能够直接将筛选得到的模型应用于临床实践指导个体化用药,实现模型引导的精准用药。

, authors=曾淑燕1, 2, 黄婉婷1, 2, 夏慧1, 2, 郭徵豪1, 2, 黄善情1, 3, 尚德为1, 3, *, authorsList=曾淑燕, 黄婉婷, 夏慧, 郭徵豪, 黄善情, 尚德为, authorCompany=null, correspAuthors=尚德为, authorNote=

曾淑燕,硕士研究生,研究方向:临床药学

, correspAuthorsNote=

*

尚德为,主任药师,研究方向:临床药学、群体药代动力学,E-mail:
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模型引导的阿立哌唑精准用药在中国精神分裂症患者的临床实践
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曾淑燕 1, 2 , 黄婉婷 1, 2 , 夏慧 1, 2 , 郭徵豪 1, 2 , 黄善情 1, 3 , 尚德为 1, 3, *
今日药学 | 临床药学 2026,36(4): 299-307
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今日药学 |临床药学 2026 , 36 (4) : 299 -307
模型引导的阿立哌唑精准用药在中国精神分裂症患者的临床实践
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曾淑燕1, 2, 黄婉婷1, 2, 夏慧1, 2, 郭徵豪1, 2, 黄善情1, 3, 尚德为1, 3, *
作者信息
  • 1.广州医科大学附属脑科医院,广东 广州 510000
  • 2.广州医科大学药学院,广东 广州 510000
  • 3.广东省神经科学疾病研究重点实验室、神经致病基因和离子通道病教育部重点实验室,广东 广州 510000
通讯作者:

*

尚德为,主任药师,研究方向:临床药学、群体药代动力学,E-mail:
作者简介:

曾淑燕,硕士研究生,研究方向:临床药学

Model-informed Precision Dosing of Aripiprazole in Chinese Patients With Schizophrenia in Clinical Practice
Shuyan ZENG1, 2, Wanting HUANG1, 2, Hui XIA1, 2, Zhihao GUO1, 2, Shanqing HUANG1, 3, Dewei SHANG1, 3, *
Affiliations
  • 1.The Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, Guangdong 510000, China
  • 2.School of Pharmacy, Guangzhou Medical University, Guangzhou, Guangdong 510000, China
  • 3.Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, Guangdong 510000, China
出版时间: 2026-04-25 doi: 10.12048/j.issn.1674-229X.2026.04.009
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目的

基于真实世界数据反向验证群体药代动力学(Population pharmacokinetics, PPK)模型的新路径,以阿立哌唑治疗精神分裂症为例,探索模型引导的精准用药(Model-informed precision dosing, MIPD)临床应用的新方法及可行性。

方法

回顾性纳入某三甲专科医院101例精神分裂症患者(1178个血药浓度点),利用PubMed、Web of Science、中国国家知识基础设施(China National Knowledge Infrastructure, CNKI)检索已发表的阿立哌唑PPK模型,通过拟合优度法(R2)和预测误差检验(PE、RPE%)对候选模型进行评价,评估已发表的PPK模型的预测性能,筛选得到符合血药浓度数据特征的模型。基于该PPK模型,应用蒙特卡洛模拟法仿真不同用药方案下阿立哌唑的稳态血药浓度范围,探索个体化用药。

结果

本研究共收集到3篇已发表的阿立哌唑的PPK模型。通过拟合优度法、预测误差检验发现,模型3最终模型的预测能力最佳。基于模型3采用蒙特卡洛模拟不同给药方案后的结果表明,10 mg qd、20 mg qd、30 mg qd方案下,相同体重患者的血药浓度:IM > EM > UM,相同CYP2D6代谢型患者的血药浓度:30 kg > 50 kg > 70 kg > 90 kg > 110 kg。

结论

通过真实世界数据的验证,在模型预测性能较为理想的情况下,能够直接将筛选得到的模型应用于临床实践指导个体化用药,实现模型引导的精准用药。

模型引导的精准用药  /  阿立哌唑  /  精神分裂症  /  群体药动学模型  /  蒙特卡洛模拟
OBJECTIVE

To establish a new pathway for the external validation of population pharmacokinetics (PPK) models based on real-world data, using aripiprazole in the treatment of schizophrenia as an example, and to explore a novel strategy for the clinical application of model-informed precision dosing (MIPD) and its feasibility.

METHODS

A total of 101 patients with schizophrenia (1 178 blood drug concentration samples) were retrospectively enrolled at a class Ⅲ Grade A specialized hospital. Published PPK models of aripiprazole were identified by searching PubMed, Web of Science, and China National Knowledge Infrastructure (CNKI). Candidate models were evaluated using goodness-of-fit (R2) prediction error tests (PE, RPE%) to assess their predictive performance, and the model consistent with the characteristics of the blood concentration data was screened. Based on the selected PPK model, Monte Carlo simulation was performed to predict the steady-state plasma concentration of aripiprazole under different dosing regimens for individualized medication.

RESULTS

Three published PPK models of aripiprazole were included in this study. Goodness-of- fit and prediction error analyses showed that Model 3 had the best predictive performance. Based on Monte Carlo simulations with Model 3, plasma concentrations under 10 mg qd, 20 mg qd, and 30 mg qd regimens were ranked as IM > EM >UM in patients with the same body weight. For patients with the same CYP2D6 metabolic phenotype, plasma concentrations decreased with increasing body weight: 30 kg > 50 kg > 70 kg > 90 kg > 110 kg.

CONCLUSION

After validation with real-world data, the screened model with satisfactory predictive performance can be directly used in clinical practice to guide individualized medication and achieve model-informed precision dosing.

model-informed precision dosing  /  aripiprazole  /  schizophrenia  /  population pharmacokinetic model  /  Monte Carlo simulation
曾淑燕, 黄婉婷, 夏慧, 郭徵豪, 黄善情, 尚德为. 模型引导的阿立哌唑精准用药在中国精神分裂症患者的临床实践. 今日药学, 2026 , 36 (4) : 299 -307 . DOI: 10.12048/j.issn.1674-229X.2026.04.009
Shuyan ZENG, Wanting HUANG, Hui XIA, Zhihao GUO, Shanqing HUANG, Dewei SHANG. Model-informed Precision Dosing of Aripiprazole in Chinese Patients With Schizophrenia in Clinical Practice[J]. Pharmacy Today, 2026 , 36 (4) : 299 -307 . DOI: 10.12048/j.issn.1674-229X.2026.04.009
  • 广东省医院药学研究基金(2023A29)
  • 广州地区临床高新、重大和特色技术项目(2023C-TS22)
  • 广州市医学重点学科(2025-2027年)
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doi: 10.12048/j.issn.1674-229X.2026.04.009
  • 接收时间:2025-05-27
  • 首发时间:2026-09-23
  • 出版时间:2026-04-25
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出版历史
  • 收稿日期:2025-05-27
基金
广东省医院药学研究基金(2023A29)
广州地区临床高新、重大和特色技术项目(2023C-TS22)
广州市医学重点学科(2025-2027年)
作者信息
    1.广州医科大学附属脑科医院,广东 广州 510000
    2.广州医科大学药学院,广东 广州 510000
    3.广东省神经科学疾病研究重点实验室、神经致病基因和离子通道病教育部重点实验室,广东 广州 510000

通讯作者:

*

尚德为,主任药师,研究方向:临床药学、群体药代动力学,E-mail:
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https://castjournals.cast.org.cn/joweb/jryx/CN/10.12048/j.issn.1674-229X.2026.04.009
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2种不同金属材料的力学参数
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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