药物基因组学在临床试验中的应用  

Application of pharmacogenomics in clinical trials

作　　者：赵楠[1,2] 张亚同[1] 程刚[2] 胡欣[1] 

机构地区：[1]卫生部北京医院药学部,北京100730 [2]沈阳药科大学药学院,沈阳110016

出　　处：《中国新药杂志》2013年第1期30-33,99,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2008ZX09312-005);卫生行业科研专项基金(200902008-03)

摘　　要：随着药物基因组学的发展,其在新药研发中逐渐被应用。新药研发是一个高投入、高风险、长周期的过程,药物基因组学在药物靶点的发现、临床前研究、临床研究以及新药上市后不良反应监测方面有重要作用。在Ⅰ～Ⅳ期临床试验中,根据基因型对受试者进行分层分析,可以减少受试者纳入人数,尽可能地减少毒性反应,节省高昂的临床研究成本,缩短上市所需时间。但是,药物基因组学在临床试验中的应用尚处于早期阶段,还面临着许多问题,随着各种新技术的研究和应用,药物基因组学在新药研发上将有更为广阔的前景。With the development of pharmacogenomics,it is gradually applied in new drug development,which is expensive,high risk and time consuming.Pharmacogenomics have beneficial effects on target identification,pre-clinical drug development,clinical trials and post marketing adverse drug reaction monitoring.In I^IV clinical trials,pharmacogenomics can be used for stratification of patients based on their genotypes.This reduces the number of volunteers and prevents the occurrence of adverse drug reactions.Further,the cost of the drug development can be reduced and the drug can be marketed earlier.However,the incorporation of pharmacogenomics into the drug development process is at an early stage and facing many difficulties.With the development of new technology,it is likely that pharmacogenomics will play an increasingly important role in drug discovery and development.

关 键 词：药物基因组学 新药研发 临床试验 基因多态性 不良反应 

分 类 号：R969[医药卫生—药理学]