| 摘要: |
| 目的:系统分析中国儿科治疗药物监测(TDM)的发展现状、存在问题及未来发展方向。方法:采用结构化问卷对中国药
理学会TDM 研究专业委员会儿童TDM 研究工作组成员单位开展回顾性调查,系统评估服务资源配置及药师认知需求,通过多
维度评分机制量化质控完整性,并应用非参数统计学方法分析。结果:最终纳入22 省、自治区、直辖市53 家三级医疗机构的有
效问卷。结果显示,我国儿科TDM 整体呈加速发展态势,但区域分布不够均衡,开展TDM 的机构47. 2%集中在华东地区。在
人才与技术层面,中级职称药师和色谱分析技术构成了当前服务体系的主力,但质量控制体系尚未健全,各机构在随行质控样
本数量标准上存在差异。药物监测结构亦不均衡,传统药物如丙戊酸的监测覆盖率达77. 4%,而奥氮平等精神类药物的监测机
构占比仅为前者的1/ 13。此外,73. 6%的药师将实验室建设困难列为主要发展障碍。临床药师在TDM 结果解读与个体化用药
决策方面的核心职能已获得高度共识。结论:中国儿科TDM 发展迅速但面临挑战。未来应致力于体系标准化、能力专业化与
服务价值化三方面建设,通过构建全流程质控闭环、提升药师高级定量药理学应用能力、加强临床与经济价值实证,最终推动
TDM 成为儿童精准医疗不可或缺的核心支撑体系。 |
| 关键词: 儿童 治疗药物监测 问卷调查 个体化给药 质量控制 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2026.01.001 |
|
| 基金项目:国家重点研发计划资助项目,编号2023YFC2706100;国家卫生健康委医院管理研究所2024 年度医院药学高质量发展研究项目
专项课题,编号NIHAZX202402。 |
|
| Survey and Development of Pediatric Therapeutic Drug Monitoring in China |
| Li Yue1, Wu Wenwen1, Guo Hongli1, Chen Feng1, Wang Xiaoling2 |
| (1. Children’s Hospital of Nanjing Medical University,
Nanjing 210008, China; 2. Beijing Children’s Hospital, Capital Medical University, Beijing 100045, China) |
| Abstract: |
| Objective: To systematically analyze the current development status, existing problems and future directions of pediatric
therapeutic drug monitoring ( TDM) in China. Methods: A structured questionnaire was administered retrospectively to member
institutions of the Pediatric TDM Research Group under the TDM Research Professional Committee of the Chinese Pharmacological
Society. The survey systematically evaluated resource allocation for TDM services and pharmacists’ cognitive needs. A multidimensional
scoring mechanism was used to quantify the integrity of quality control, and non-parametric statistical methods were applied
to analyze differences. Results: Valid questionnaires from 53 tertiary medical institutions across 22 provinces,autonomous regions and
municipality were included in the final analysis. The study revealed that the overall trend of pediatric TDM in China was experiencing
accelerated development. However, its geographical distribution was uneven, with 47. 2% of the institutions offering services located in
East China. In terms of expertise and technology, intermediate professional titles in pharmacists and chromatographic analysis technology
held the main force of the current service system. Nevertheless, quality control systems was still underdeveloped, with significant variations
observed among institutions regarding standards for the number of accompanying quality control samples. The spectrum of monitored drugs
was also imbalanced: traditional drugs like valproic acid reached a monitoring coverage rate of 77. 4%, whereas monitoring for psychiatric
agents like olanzapine was offered by only 1/ 13 of that proportion. Furthermore, 73. 6% of pharmacists identified laboratory development
difficulties as the primary obstacle to growth. On a positive note, a high degree of consensus recognized the clinical pharmacists’ core role
in interpreting TDM results and guiding personalized medication decisions. Conclusion: The development of pediatric TDM in China is
rapid yet faces significant challenges. Future efforts should focus on establishing a trinity of system standardization, expertise specialization,
and service value demonstration, which include establishing a closed-loop quality control process for the entire workflow, enhancing
pharmacists’ proficiency in advanced quantitative pharmacology, and strengthening evidence for clinical and economic value. Ultimately,
these actions will promote TDM as an indispensable core pillar supporting precision medicine for children in China. |
| Key words: children therapeutic drug monitoring questionnaire survey individualized medication quality control |
