全国医疗及相关机构治疗药物监测项目开展情况调查  

A Survey on the Implementation of Therapeutic Drug Monitoring Projects in Medical and Related Institutions Across China

作　　者：刘筱雪[1] 周伟燕[2] 黄晨蓉 邓宇航 虞勋[1] 缪丽燕[1] 张传宝[2] LIU Xiaoxue;ZHOU Weiyan;HUANG Chenrong;DENG Yuhang;YU Xun;MIAO Liyan;ZHANG Chuanbao(Department of Pharmacy,the First Affiliated Hospital of Soochow University,Suzhou 215006,China;National Center of Gerontology,Beijing Hospital,National Center for Clinical Laboratories,Beijing Engineering Research Center of Laboratory Medicine,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]苏州大学附属第一医院药学部,苏州215006 [2]北京医院国家老年医学中心,国家卫生健康委临床检验中心,北京市临床检验工程技术研究中心,中国医学科学院老年医学研究院,北京100730

出　　处：《医药导报》2022年第11期1699-1710,共12页Herald of Medicine

基　　金：国家自然科学基金资助项目(81703619)。

摘　　要：目的对2021年度全国医疗及相关机构开展治疗药物监测(TDM)的检测项目、检测方法及样本量进行问卷调查和分析,为TDM检测项目开展、试剂盒研发和室间质评等质量控制活动的开展提供参考。方法基于网络平台发起问卷调查,对回收的问卷双人核对录入Excel建立数据库,并对无效数据进行补充调查或剔除。随后基于锁库的数据采用柱状图结合数据表格方式对开展单位的上报数量、主要检测方法、总体样本量水平及各药物类别下各品种检测量进行汇总、分析。结果①TDM在临床上具备较大开展需求,其中精神类药物、抗菌药物、免疫抑制药和抗肿瘤药为开展量较大的药物类别;②TDM临床检测方法多样,其中基于化学发光免疫分析(CLIA)、电化学发光免疫分析(ECLIA)原理的免疫分析方法和基于高效液相色谱法(HPLC)、高效液相色谱-串联质谱法(HPLC-MS/MS)的色谱分析方法应用普遍。结论我国医疗机构对TDM检测有着广泛需求。目前各检测单位间存在多种检测方法并行及以色谱分析为代表的实验室自建方法(LDT)大量应用的状况。室间质量评价计划和室内质量控制方法的完善仍是未来TDM质量管理的重点。Objective To investigate and analyze the therapeutic drug monitoring(TDM)testing items,methods and sample sizes carried out by various institutions across China by questionnaires in 2021,and to provide a reference for the development of TDM testing items,testing kits and quality control activities such as external quality assessment.Methods Based on the network platform,the survey was initiated in the form of questionnaires.The returned questionnaires were checked and entered into Excel to establish a database,and invalid data were supplemented or eliminated.Then,based on the data of the locked library,the number of institutions,the detection methods adopted,the overall sample size and the detection amount of each drug variety under each category were summarized and analyzed by using a bar chart combined with a data table.Results①TDM has a large clinical development demand,among which psychotropic drugs,antibacterial drugs,immunosuppressive drugs and anti-tumor drugs are the drug categories with a large amount of development.②There were various clinical testing methods based on immunoassay methods like chemiluminescence immunoassay(CLIA),electro-chemiluminescence immunoassay(ECLIA)and chromatographic analysis like high performance liquid chromatography(HPLC)and HPLC-tandem mass spectrometry(HPLC-MS/MS).Conclusion In China,the medical institutions have extensive need for TDM testing.At present,there are multiple testing methods being used in parallel among various institutions.At the same time,laboratory developed tests(LDT)represented by chromatographic analysis are widely used.Therefore,the improvement of the external quality evaluation and the indoor quality control method is still the focus of TDM quality management in the future.

关 键 词：治疗药物监测 医疗机构 问卷调查 

分 类 号：R95[医药卫生—药学] R969