个体差异引起的用药剂量不当可能导致治疗失败甚至毒副作用，个体化医疗是发展方向。肝脏代谢酶CYP2D6参与代谢众多药物，其基因多态性可引起显著的个体疗效差异。使用相关药物前评估CYP2D6代谢表型对个体化用药剂量选择发挥重要作用。传统检测代谢表型方法耗时有风险。本研究以右美沙芬为探针药物，建立高效液相色谱法检测人血、尿及唾液中的右美沙芬和其代谢物右啡烷浓度。首次在较大样本中国人群中同时检测CYP2D6代谢表型和基因型并探索建立CYP2D6基因型-代谢表型预测模型。前景是通过基因型预测个体化用药剂量，高效低风险。申请人前期研究已建立优化的CYP2D6代谢表型检测方法，解决了这项关键的技术难题。CYP2D6复杂的多态性具有种族差异，且使研究需要较大样本量，国际上此类研究较少、不完善，且集中在西方人。本研究不仅将填补国人数据的空白，还将基于国人数据发展模型，为国人个体化用药提供理论基础和应用模型。

Individual differences may lead to inappropriate therapeutic doses and even therapeutic failures or adverse effects, and individualized therapy may be the solution. Hepatic enzyme CYP2D6 plays a role in metabolizing many medicines and its genetic polymorphism results in significant individual therapeutic difference. Estimating the phenotype of CYP2D6 before the administration of its substrate will be of great benefit to individualized dosing strategies. Traditional phenotyping method is time-consuming and risky. In the present study, dextromethorphan is taken as a probe drug, and plasma, saliva and urine samples will be analyzed with HPLC-MS/MS. It will be the first study to test phenotype and genotype of CYP2D6 in a large sample of Chinese population, to establish a CYP2D6 genotype-phenotype predicting model. An optimized phenotyping method of CYP2D6 has been established in preliminary work, which solved the key technical problems. The complex polymorphism of CYP2D6 is ethnicity dependent and requires large sample size. Currently the studies in this field are insufficient and focus on western populations only. The data from this study will fill the gaps for Chinese population, and the CYP2D6 genotype-phenotype predicting model based on Chinese data will provide the theoretical basis and application model for individualized therapy in Chinese.