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·药事管理·

基于改良德尔菲法的《治疗药物监测管理指南》研究问题体系
构建
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3
1， 2 #
段 蓉 1， 2＊ ，缪丽燕 ，李正翔 （1.天津医科大学总医院药学中心，天津 300052；2.天津市药品使用监测和临
床综合评价中心，天津 300052；3.苏州大学附属第一医院药学部，江苏 苏州 215006）

中图分类号 R95；R969.3 文献标志码 A 文章编号 1001-0408（2026）10-1241-05
DOI 10.6039/j.issn.1001-0408.2026.10.01

摘 要 目的 构建《治疗药物监测管理指南》（以下简称《指南》）的研究问题体系，为《指南》的制定提供依据。方法 在文献研究
和专家访谈的基础上，初步构建《指南》研究问题调查问卷，通过改良德尔菲法对《指南》制定专家进行线上问卷调研并召开专家共
识会议，确定《指南》研究问题体系。结果 共发放调研问卷59份，回收有效问卷52份，专家积极系数为88.14%。纳入专家来自21
个省/自治区/直辖市，涵盖治疗药物监测相关多学科专家，均具有高级专业技术职称。调研专家经过一轮调研即对研究问题达成
共识，形成了涵盖治疗药物监测开展指征（4个一级研究问题、10个二级研究问题、31个三级研究问题）、治疗药物监测技术流程（3
个一级研究问题、9个二级研究问题、13个三级研究问题）、结果解读及临床应用（3个一级研究问题、3个二级研究问题）、质量控制
（8 个一级研究问题、12 个二级研究问题）4 个板块的研究问题体系。4 个板块的重要性评分为 4.71～4.88 分，满分率均不低于
73.08%，专家权威系数均不低于 0.90，重要性评分变异系数均不高于 0.11，肯德尔协调系数 W 为 0.464～0.626（P 均小于 0.05）。
结论 构建的研究问题体系具有较高的权威性、科学性和可靠性，可为《指南》标准化制定奠定基础。
关键词 治疗药物监测；研究问题；体系构建；管理指南；改良德尔菲法

Construction of the research question system of the Guideline for the Management of Therapeutic Drug
Monitoring based on modified Delphi method
1， 2
3
DUAN Rong ，MIAO Liyan ，LI Zhengxiang （1. Pharmacy Center， Tianjin Medical University General
1， 2
Hospital， Tianjin 300052， China；2. Tianjin Center for Drug Use Monitoring and Clinical Comprehensive
Evaluation， Tianjin 300052， China；3. Dept. of Pharmacy， the First Affiliated Hospital of Soochow University，
Jiangsu Suzhou 215006， China）
ABSTRACT OBJECTIVE To construct a research question system of the Guideline for the Management of Therapeutic Drug
Monitoring （hereinafter referred to as the Guideline）， so as to provide the basis for the formulation of the Guideline. METHODS
Based on literature research and expert interviews， the questionnaire about research questions of the Guideline was initially
constructed. Through the modified Delphi method， the online questionnaire survey and expert consensus meeting were conducted
among the Guideline development experts to determine the research question system of the Guideline. RESULTS A total of 59
questionnaires were distributed， and 52 valid questionnaires were collected. The positive coefficient of experts was 88.14%. The
experts came from 21 provinces/autonomous regions/municipalities directly under the central government， covering multidisciplinary
experts related to therapeutic drug monitoring， all of whom held senior professional titles. After one round of survey， a consensus
was reached on the research questions， and a research question framework encompassing four research parts was constructed，
including： indications for conducting therapeutic drug monitoring （4 first-level research questions，10 second-level research
questions， 31 third-level research questions）； therapeutic drug monitoring technical process （3 first-level research questions， 9
second-level research questions， 13 third-level research questions）； result interpretation and clinical application （3 first-level
research questions and 3 second-level research questions）； quality control （8 first-level research questions and 12 second-level
research questions）. The importance scores for the four parts ranged from 4.71 to 4.88， with full-score rates all no less than
73.08%. The expert authority coefficients were all no less than 0.90， the coefficients of variation of importance scores were all no
higher than 0.11， and Kendall’s W ranged from 0.464 to 0.626 （all P＜0.05）. CONCLUSIONS The constructed research question
system has high authority， scientificity， and reliability， laying
Δ 基金项目 天津市药品临床综合评价项目（No.TZH-2025-017）
＊第一作者 副主任药师，硕士。研究方向：药品临床综合评价、治 a foundation for the standardized formulation of the Guideline.
疗药物监测。E-mail：duanrong2001@163.com KEYWORDS therapeutic drug monitoring； research questions；
# 通信作者 主任药师。研究方向：医院药学、治疗药物监测、药品 system development； management guideline； modified Delphi
临床综合评价。E-mail：13820893896@163.com method

中国药房 2026年第37卷第10期 China Pharmacy 2026 Vol. 37 No. 10 · 1241 ·