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治疗药物监测管理指南
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| 篇名： | 治疗药物监测管理指南 |
| TITLE： | Guidelines for the management of therapeutic drug monitoring |
| 摘要： | 目的 为进一步规范治疗药物监测（TDM）全流程技术操作与管理环节，明确项目开展的临床价值，提升监测结果的科学性、可靠性，为临床个体化精准给药方案的制定与优化提供参考依据。方法遵循美国国家科学院医学研究所关于指南的最新定义及世界卫生组织标准指南制定方法学，依据指南研究与评价工具要求制定《治疗药物监测管理指南》。该指南采用改良德尔菲法构建研究问题体系；应用循证医学研究方法系统检索多个数据库，筛选最新、最全的研究证据，依据中国循证医学中心的证据分级体系进行证据评价，采用牛津大学循证医学中心的推荐强度分级标准确定推荐强度，结合多学科专家共识形成推荐意见。结果《治疗药物监测管理指南》涵盖TDM开展指征、TDM技术流程、结果解读及临床应用、质量控制4个核心模块，涉及18个一级研究问题、34个二级研究问题，形成82条推荐意见。结论该指南系统规范了TDM全流程关键技术环节与管理要求，提供了科学、可操作的标准化工具，有助于提升TDM工作的同质化水平，促进监测结果向临床决策转化，为精准个体化用药、保障用药安全合理提供支撑。 |
| ABSTRACT： | OBJECTIVE To further standardize the technical operations and management processes throughout therapeutic drug monitoring （TDM）， clarify the clinical value of TDM implementation， improve the scientific validity and reliability of monitoring results， and provide a solid reference basis for the formulation and optimization of clinical individualized precision dosing regimens. METHODS The Guidelines for the Management of Therapeutic Drug Monitoring were formulated in accordance with the latest definition of guidelines by the Institute of Medicine of the National Academies and the standard guideline development methodology of the World Health Organization， and in compliance with the requirements of the appraisal of guidelines for research and evaluation. A modified Delphi method was adopted to establish the research question system； evidence-based medicine research methods were applied to systematically search multiple databases to screen the latest and most comprehensive evidence. Evidence was graded and evaluated based on the evidence grading system of the Chinese Evidence-Based Medicine Center， and the grading criteria for recommendation strength from the Oxford Centre for Evidence-Based Medicine were used to determine the recommendation strength. The recommendation opinions were formed through multidisciplinary expert consensus. RESULTS The Guidelines for the Management of Therapeutic Drug Monitoring cover four core modules， including TDM application indications， technical procedures， result interpretation and clinical application， and quality control， involving 18 primary research questions， 34 secondary research questions， and yield 82 recommendations. CONCLUSIONS The guidelines systematically standardize the key technical links and management requirements of the whole TDM process， provide scientific and operable standardized tools， help improve the standardization level of TDM work， promote the translation of monitoring results into clinical decision-making， and provide strong support for precision personalized medicine and ensuring the safety and rationality of medication use. |
| 期刊： | 2026年第37卷第11期 |
| 作者： | 李正翔；缪丽燕；段蓉；左笑丛；张相林；王卓；颜苗；张伶俐；赵荣生；翟所迪；高国彪；田金徽 |
| AUTHORS： | LI Zhengxiang，MIAO Liyan，DUAN Rong，ZUO Xiaocong，ZHANG Xianglin， WANG Zhuo，YAN Miao，ZHANG Lingli，ZHAO Rongsheng，ZHAI Suodi，GAO Guobiao，TIAN Jinhui |
| 关键字： | 治疗药物监测; 管理指南; 团体标准; 循证医学; 个体化用药 |
| KEYWORDS： | therapeutic drug monitoring; management guidelines; group standard; evidence-based medicine; individualized medication |
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