基于2014-2019年室间质评数据的我国临床药物基因组学发展现状分析
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篇名: 基于2014-2019年室间质评数据的我国临床药物基因组学发展现状分析
TITLE: Analysis of the Development Status of Clinical Pharmacogenomics Based on External Quality Assessment from 2014 to 2019 in China
摘要: 目的:为推进临床个体化用药提供参考。方法:在国家卫生健康委临床检验中心(NCCL)和国家药品监督管理局(NMPA)官网上提取截至2019年12月31日的有关化学药物用药指导的基因检测室间质量评价(EQA)项目及获批试剂盒的相关信息,统计各项目参评实验室数量;以参与度较高的华法林和氯吡格雷药物代谢基因多态性检测EQA项目为例,分析各参评实验室所用方法和检测试剂盒情况,以分析我国临床药物基因组学(PGx)的发展现状。结果:NCCL开展的药物基因检测EQA项目从2014年的3项增至2019年的9项;参评实验室总数2018年为926个,2019年为1249个。华法林和氯吡格雷药物代谢基因多态性检测参评实验室数分别由最初的57、124个增至300.5、374.5个,各实验室使用较广泛的方法均为荧光聚合酶链式反应(PCR)法和PCR-芯片杂交法;目前,上述两个项目获NMPA批准的试剂盒数量分别为7、15个,但仍有部分参评实验室使用自配试剂。结论:我国临床PGx处于起步阶段,实验室的参评意识逐年提高;使用方法以荧光PCR法为主,但仍普遍存在使用自配试剂的情况,相关审批、使用、监管的制度均有待进一步完善。
ABSTRACT: OBJECTIVE:To provide reference for promoting individualized medication in clinic. METHODS :Information on external quality assessment (EQA)projects and approved kits for the guidance of chemical drug use were collected from the websites of National Center for Clinical Laboratories (NCCL) and National Medical Products Administration (NMPA) as of December 31,2019. The number of laboratories participating in each evaluation project was count. Taking EQA projects of clopidogrel and warfarin drug metabolism gene polymorphism detection as examples ,who was with the highest participation rate , the methods and reagent kits of each laboratory were analyzed so as to analyze the current status of the clinical pharmacogenomics (PGx)in China. RESULTS :The number of PGx genetic test EQA projects conducted by NCCL increased from 3(2014)to 9 (2019). The total number of participating laboratories was 926 in 2018,and 1 249 in 2019. The number of laboratories of warfarin and clopidogrel drug metabolism gene polymorphism detection increased from 57 to 300.5 for warfarin and from 124 to 374.5 for clopidogrel. The more widely used methods were fluorescent PCR and PCR-chip hybridization. The number of reagent kits currently approved by NMPA was 7 for warfarin and 15 for clopidogrel ,respectively. But some of the laboratories participating in EQA used self-prepared reagents yet. CONCLUSIONS :The clinical PGx is in its infancy ,and the awareness of laboratories about EQA is improving;the main method was fluorescence PCR ,but the use of self-made reagents in laboratories is still common ,regulations concerning the approval ,use and supervision still need to be further improved.
期刊: 2020年第31卷第16期
作者: 陈幽攸,李华云,任小群,代颜
AUTHORS: CHEN Youyou ,LI Huayun ,REN Xiaoqun ,DAI Yan
关键字: 临床药物基因组学;室间质量评价;个体化用药;华法林;氯吡格雷;发展现状
KEYWORDS: Clinical pharmac ogenomics;External quality assessment ;In vitro diagnostic reagents ;Warfarin;Clopidogrel;
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