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中国临床药理学与治疗学 ›› 2024, Vol. 29 ›› Issue (12): 1322-1328.doi: 10.12092/j.issn.1009-2501.2024.12.001

• “特殊人群药物精准治疗服务与研究”专栏 • 上一篇    下一篇

他克莫司治疗药物监测异常结果干预及评价研究

王学彬1,2,3,高丽红2,张凌鹏2,杨云云2,刘红霞1,王卓2,孙华君1   

  1. 1上海市儿童医院 药学部,上海  200062;2海军军医大学第一附属医院 药剂科,上海  200433;3复旦大学药学院 生物药物系,上海  201203

  • 收稿日期:2024-07-01 修回日期:2024-08-27 出版日期:2024-12-26 发布日期:2024-11-18
  • 通讯作者: 王卓,博士,主任药师,博导,研究方向:临床药学。 E-mail: wangzhuo088@163.com 孙华君,博士,主任药师,研究方向:医院药学。 E-mail: sunhj1@shchildren.com.cn
  • 作者简介:王学彬,男,博士研究生,副主任药师,硕导,研究方向:临床药学。 E-mail: binxuewang@126.com
  • 基金资助:
    国家自然科学基金资助项目(82173900);促进市级医院临床技能与临床创新能力三年行动计划(SHDC2020CR4072);2022年上海青年药学人才能力提升项目(沪药会字[2023]04号)

Study on the intervention and evaluation for the abnormal results of tacrolimus therapeutic drug monitoring 

WANG Xuebin1,2,3, GAO Lihong2, ZHANG Lingpeng2, YANG Yunyun2, LIU Hongxia1, WANG Zhuo2, SUN Huajun1   

  1. 1 Department of Pharmacy, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200062, China; 2 Department of Pharmacy, Shanghai Changhai Hospital, Naval Medical University, Shanghai 200433, China; 3 Department of Biological Medicines & Shanghai Engineering Research Center of Immunotherapeutics, Fudan University School of Pharmacy, Shanghai 201203, China 
  • Received:2024-07-01 Revised:2024-08-27 Online:2024-12-26 Published:2024-11-18

摘要:

目的:探究欧洲医药保健网(Pharmaceutical Care Network Europe,PCNE)分类系统用于评价肾移植受者他克莫司浓度波动药物相关问题(drug related problems,DRPs)的作用。方法:以门诊随访中出现他克莫司血药浓度波动、临床药师介入干预的肾移植受者为研究对象,利用PCNE(9.0)分类系统评价他克莫司的DRPs,并对存在DRPs的问题、原因、介入方案、介入方案的接受和状态进行分析。结果:本研究纳入2019年7月至2021年12月肾移植受者700例,发现1 014个他克莫司DRPs。DRPs的问题包括发生药物不良事件(P2.1,60.16%)和治疗效果不佳(P1.2,39.84%);原因主要包括剂量选择(C3,43%)、其他(C9,38.4%)和药物选择(C1,9.41%);临床药师从受者层面(I2,98.92%)和药物层面(I3,1.08%)积极介入;介入方案(A1.1+A1.3)的接受率达98.62%,完全执行(A1.1)率达72.09%;79.29%的DPRs被全部解决或部分解决(O1.1和O2.1)。结论:临床药师可将PCNE用于评价他克莫司治疗药物监测(therapeutic drug monitoring,TDM)相关DRPs,助力TDM药学服务模式标准化,规范TDM异常结果解读和干预工作,促进安全合理用药。

关键词: 肾移植, 他克莫司, 治疗药物监测, 结果干预, 欧洲医药保健网

Abstract:

AIM: To analyze the Pharmaceutical Care Network Europe (PCNE) classification system used for evaluating the drug related problems (DRPs) of tacrolimus concentration fluctuations in kidney transplant recipients. METHODS: Kidney transplant recipients were selected as the study subjects, who experienced fluctuations in tacrolimus blood concentrations and clinical pharmacist intervention during outpatient follow-up. PCNE (9.0) classification system was used to evaluate the DRPs of tacrolimus. And the DRP problems, causes, intervention plans, acceptance and status were analyzed. RESULTS: A total of 700 kidney transplant recipients were enrolled from July 2019 to December 2021, and 1014 DRPs were found. The problems of DRPs included the occurrence of adverse drug events (P2.1, 60.16%) and poor treatment outcomes (P1.2, 39.84%); The main reasons included dosage selection (C3, 43%), others (C9, 38.4%), and drug selection (C1, 9.41%); Clinical pharmacists actively intervened at the recipient level (I2, 98.92%) and drug level (I3, 1.08%); The acceptance rate of the intervention plan (A1.1+A1.3) reached 98.62%, and the complete implementation rate (A1.1) reached 72.09%; 79.29% of DPRs were fully or partially resolved (O1.1 and O2.1). CONCLUSION: Clinical pharmacists can use PCNE to evaluate tacrolimus therapeutic drug monitoring (TDM) related DRPs, help standardize TDM pharmaceutical service models, standardize TDM abnormal result interpretation and intervention workflows, and promote safe and rational drug utilization.

Key words: kidney transplantation, tacrolimus, therapeutic drug monitoring, outcome intervention, Pharmaceutical Care Network Europe

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