Analysis of the Development Status of Clinical Pharmacogenomics Based on External Quality Assessment from 2014 to 2019 in China
- VernacularTitle: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
- Author:
Youyou CHEN
1
;
Huayun LI
1
;
Xiaoqun REN
1
;
Yan DAI
1
Author Information
1. Dept. of Pharmacy，the Affiliated Hospital of Southwest Medical University，Sichuan Luzhou 646000，China
- Publication Type:Journal Article
- Keywords:
Clinical pharmac ogenomics;
External quality assessment;
In vitro diagnostic reagents;
Warfarin;
Clopidogrel
- From:
China Pharmacy
2020;31(16):1938-1943
- CountryChina
- Language:Chinese
-
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.
