Department of Pharmacy，Xiangya Hospital，Central South University，Changsha，China.
Ther Drug Monit. 2023 Apr 1;45(2):151-158. doi: 10.1097/FTD.0000000000001060. Epub 2023 Mar 1.
To understand the status of therapeutic drug monitoring (TDM) in China Mainland, and thus lay down the foundation for further improvement in TDM.
In the present study, a nationwide questionnaire survey was conducted, which was distributed and collected using a mobile-based application. Clinicians, pharmacists, and clinical laboratory physicians belonging to different levels of public hospitals were involved as subjects/objects. The contents of the survey included TDM implementation in their hospital and information regarding their opinions and suggestions on TDM work. Mann-Whitney test was used to compare the difference between top tertiary hospitals and non-top tertiary hospitals.
A total of 475 questionnaires were collected, 383 from top tertiary hospitals (3A hospitals) and 92 from non-top tertiary hospitals (other than 3A hospitals). A total of 240 clinicians, TDM pharmacists, and clinical laboratory physicians were involved, with an effective rate of 50.5%. Top tertiary hospitals were associated with certain advantages, such as the number of TDM testing facilities, annual sample size, number of monitoring varieties, and interpretation rate of monitoring reports, compared with non-top tertiary hospitals. In particular, β-lactamase inhibitor, olanzapine, carbamazepine, and glucocorticoids seemed to be the main projects that clinicians wanted to assess. The drugs for which TDM was commonly performed included vancomycin, valproic acid, carbamazepine, phenytoin sodium, and methotrexate. The most commonly used detection methods include high-performance liquid chromatography, immunization, 2D-LC, and LC-MS. The monitoring concentration range was found to be inconsistent for most of the drugs. Currently, no unified regulation exists for TDM charges in China, which is no more than ¥200 in general. Clinicians rely on pharmacists for professional guidance. Importantly, improvement in the interpretation of monitoring reports, proficiency testing, and cooperation with clinical departments may aid in improving the level of TDM service.
This survey objectively reflected the current status of TDM work in hospitals in China, and provided a strong reference base for devising strategies for improvement and effective execution of TDM work.
了解中国大陆治疗药物监测（TDM）的现状，为进一步提高 TDM 水平奠定基础。
本研究采用基于移动应用的问卷调查方式，对不同级别公立医院的临床医生、药师和临床检验科医师进行了全国范围的调查。调查内容包括医院 TDM 的开展情况以及他们对 TDM 工作的意见和建议。采用 Mann-Whitney 检验比较了三甲医院和非三甲医院之间的差异。
共收集问卷 475 份，其中三甲医院 383 份，非三甲医院 92 份。共纳入 240 名临床医生、TDM 药师和临床检验科医师，有效率为 50.5%。三甲医院在 TDM 检测设备数量、年样本量、监测品种数、监测报告解读率等方面均优于非三甲医院。特别是β-内酰胺酶抑制剂、奥氮平、卡马西平、糖皮质激素似乎是临床医生希望评估的主要项目。TDM 常用药物包括万古霉素、丙戊酸、卡马西平、苯妥英钠和甲氨蝶呤。最常用的检测方法包括高效液相色谱法、免疫法、二维液相色谱法和 LC-MS。大多数药物的监测浓度范围不一致。目前，中国尚未对 TDM 收费制定统一规定，一般不超过 200 元人民币。临床医生依赖药师的专业指导。重要的是，提高监测报告解读能力、能力验证和与临床科室的合作，可能有助于提高 TDM 服务水平。
本调查客观反映了中国医院 TDM 工作的现状，为制定改进策略和有效执行 TDM 工作提供了有力的参考依据。
