2018年中国医院治疗药物监测开展状况调查

Survey on the Development of Therapeutic Drug Monitoring in Chinese Hospitals in 2018

目的了解国内医院治疗药物监测(TDM)工作开展概况,为学科发展和规划提供指导。方法对全国医院TDM进行网络问卷调查,包括:基本信息、TDM实验室及临床科室开展情况、监测药品种类及数量、质量控制、报告解读及个体化给药方案制定、审批与管理等共7部分33条问题。进行数据清洗,有效数据纳入统计。结果共纳入463份有效问卷,其中177家医院开展了TDM工作,具体情况为:学历以硕士(43%)和本科(33%)为主;75%医院建立色谱分析法开展TDM;监测项目主要为血药浓度检测(63%)和药物基因检测(36%);开展科室以神经内科最多。本次共调研11类药物2018年TDM情况,结果显示精神障碍类药物监测品种最多(18个),免疫抑制剂的监测数量最多(57%)。64%医疗机构开展质控。50%医院配套临床解读,75%显示临床药师参与解读;82%根据结果制定个体化方案。65%的医院开展了TDM审核审批制度,47%纳入医院药事管理与药物治疗学委员会管理制度。结论本次问卷获得了以上7个方面的现状,掌握了11类药物2018年TDM概况,但质控、临床解读、个体化方案制定和TDM管理方面仍存在发展不充分现象,未来TDM工作除了开展药物的检测,还有注重完善和发展以上不足之处,促进临床合理用药。

OBJECTIVE To understand the development of therapeutic drug monitoring( TDM) in domestic hospitals and provide guidance for disciplinary development. METHODS A range of professions involved in 7 aspects( 33 questions) of TDM were surveyed by questionnaire on WeChat in late 2018. Information gathered included: basic information,development of TDM laboratories and clinical departments,monitoring drug types and quantity,quality control,interpretation of reports and individual drug regimen,and approval and management. These data were exported in Excel,and the valid data were included. RESULTS Five hundred and four responses were received,of which 463 were valid and included,of which 177 hospitals developed TDM. The results of the above 7 aspects which were from those 177 hospitals in 2018 were summarized as follows. The educational backgrounds were mainly the master degree( 43 %) and the bachelor degree( 33 %). Most hospitals( 75 %) established chromatographic methods. The monitoring items were mainly blood drug concentration test( 63 %) and drug genetic testing( 36%). In all clinical departments,TDM was most applied in Neurology. Eleven categories of drugs applying TDM in 2018 were investigated,of which psychotic drugs with the most varieties included eighteen drugs,and immunosuppressive agents had the most samples monitoring( 57 %). Over one half of hospital( 64 %) carried out the quality control. Only one half of hospitals( 89/177) developed clinical interpretation,of which 75% showed that clinical pharmacists participated in the interpretation;82 % developed individualized plans based on the results. Most hospitals( 65 %) carried out the TDM review and the systems of examination and approval,and TDM in 47 % of the hospitals was included in the hospital pharmacy management and drug therapy committee management system. CONCLUSION This survey has obtained information of the seven aspects,and has mastered the TDM profile of 11 categories of drugs in 2018. However,there is still insufficient development in the quality control,clinical interpretation,individualized regimen development and TDM management. In addition to conducting drug monitoring,TDM work in the future will focus on improving and developing the above deficiencies and promoting clinical rational drug use.