治疗药物监测（TDM）对于保障合理性和个体化给药至关重要。我国分级诊疗制度实施之后，对临床药学服务的需求不断增大，而目前基于色谱、光谱、免疫的药物分析技术不利于该工作的广泛开展和普及。同时，目前国内外对于不合理用药引起的药物性肝病（DILD）普遍重视不足，并缺乏相关检测手段，使得DILD处于高发态势。本申请拟建立一套基于微流控传感技术的复合平台，可以同时监测患者药物治疗期间的血药浓度和肝功指标，实现TDM与DILD快速预警和诊断。检测的核心元件分别是纳米材料和分子印迹聚合物双重修饰的电化学传感芯片和多重酶修饰的生物传感芯片。在前期工作基础上，该传感系统中整合了基于多种检测原理的电化学分析技术，以达到检测体系普适性的目的。将得到的药动学数据与肝脏器指标进行关联分析，建立药物性肝损害预警机制，提高药物治疗的有效性及安全性。建立的技术和平台将最终在临床科室进行应用和推广。

Therapeutic drug monitoring (TDM) is essential for ensuring the rationality of medication and achieving individualized drug administration. Since the hierarchical diagnosis and treatment system has been implemented in China, the requirement for clinical pharmacy service is gradually increasing. However, the present pharmaceutical analysis techniques are mostly based on chromatography, spectroscopy, immunoassay, etc., which are not conducive to extensive application of clinical pharmaceutical work, consequently hindering the China's medical reform and development. On the other side, drug-induced liver disease (DILD) has been paid insufficient attention all over the world, along with lack of effective detection and evaluation strategy of DILD. Both of them pose the disease under high incidence rate. This application aims to construct a composite platform based on microfluidic sensing technology, which can simultaneously monitor blood concentration and hepatic function during drug treatment. This platform is expected to realize real-time TDM and achieve rapid alert and diagnosis of DILD. The key elements of the detection system include nano-materials and molecularly imprinted film modified electrochemical sensor chips and multiplex enzyme modified biosensor chips. Electrochemical techniques based on different assay principles are also integrated into the microfluidic chip system in order to make it widely applicable towards different drugs. After that, association analysis between the obtained pharmacokinetic data and hepatic function indexes will be carried out, and early warning of drug-induced liver injury will be established. Finally, the developed technique and platform will be put into use in clinical departments for testing its practicability and to improve effectiveness and safety of drug therapy.