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药物基因组学个体化用药证据基础分析与评价
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篇名: 药物基因组学个体化用药证据基础分析与评价
TITLE:
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PubMed、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,某特定基因可引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。
ABSTRACT: 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 PubMed, 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 only 38.06% 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.
期刊: 2016年第27卷第8期
编辑: 王一珂,马旭,焦园园,邵宏,张艳华
AUTHORS: WANG Yike,MA Xu,JIAO Yuanyuan,SHAO Hong,ZHANG Yanhua
关键字: 药物基因组学;个体化用药;文献分析;证据分析;精准医疗
KEYWORDS: Pharmacogenetics; Personalized medicine; Literature analysis; Evidence analysis; Precision medicine
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