摘要
目的:评价药物基因组学个体化用药的证据基础,为临床提供参考。方法:以"phamracogenetics""pharmacogenomics""药物基因组学""基因多态性"等为关键词,组合检索Pub Med、中国知网、万方等数据库中相关文献及临床指南,对其涉及的基因、位点、药物类别等进行分析;根据基因组学在实践和预防中应用的评估指南,对添加药物基因组学生物标志物的药品说明书的证据基础进行评价。结果:检索出有效文献8 276篇,临床指南25篇,评价药品说明书166份。药物基因组学的文献多集中于某一基因与不同药物的相关性研究上;临床指南显示,某特定基因可指导多个药物在不同领域的临床使用;由说明书的评估结果可见,临床证据总体级别不高,含可检测的生物标志物的药物种类不多,若排除靶向制剂,其总可检测率仅为38.06%。结论:在临床证据总体级别不高的情况下,需谨慎对待药物基因组学生物标志物的检测,并进一步加强其基础研究。
OBJECTIVE：To evaluate evidence foundation of phamracogenetics personalized medication,and to provide reference for clinical application. METHODS： Using ＂phamracogenetics＂＂pharmacogenomics＂ and ＂gene polymorphism＂ as key words,related literatures and clinical guideline were retrieved from Pub Med,CNKI,Wanfang database,and analyzed in respects of involved gene,site and drug types,etc. Evidences of package inserts of phamracogenetics biomarker were evaluated by using phamracogenetics practice and prevention evaluation guideline. RESULTS：8 276 papers,25 guidelines and 166 drug package inserts are available for analysis. The phamracogenetics literatures mostly focus on the relationship between some one gene and different drugs. In guidelines,some one specific gene can guide clinical application of multiple drugs in different fields. In drug package inserts,general level of clinical evidence is not high;detectable biomarkers is inadequate in category,and detection rate is only38.06% besides targeting preparation. CONCLUSIONS：Under the condition of low clinical evidence level the detection of pharmacogenetics biomarker should be conducted carefully,and basic study should be further strengthened.
出处
《中国药房》
CAS
北大核心
2016年第8期1009-1012,共4页
China Pharmacy
关键词
药物基因组学
个体化用药
文献分析
证据分析
精准医疗
Pharmacogenetics
Personalized medicine
Literature analysis
Evidence analysis
Precision medicine
