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一项全国范围内的调查:在中国儿童精准治疗中临床实施 PGx 检测的情况:距离标准临床实践还有很长的路要走。

A national-wide survey on clinical implementation of PGx testing into precision therapeutics for Chinese children: a long way before standard clinical practice.

机构信息

Department of Pharmacy, Children's Hospital of Nanjing Medical University, Nanjing, China.

School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China.

出版信息

BMC Health Serv Res. 2024 Sep 18;24(1):1089. doi: 10.1186/s12913-024-11535-6.

DOI:10.1186/s12913-024-11535-6
PMID:39294738
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11409549/
Abstract

BACKGROUND

Pharmacogenetics/pharmacogenomics (PGx) focuses on the genetic variation that causes the heterogeneity of pharmacokinetics and drug response among individuals and has the potential to predict individual efficacy and/or side effects. This study aims to investigate and understand the implementation of genetic testing for the personalized medication (GTPM) in children's hospitals in Mainland China.

METHODS

A survey was conducted on 50 children's hospitals from 31 provinces, municipalities, and autonomous regions across Mainland China, and statistical analysis and recommendations were made.

RESULTS

Questionnaire response was rate of 76.0% (38/50). Data from 15 hospitals conducting GTPM were included in this study, but only 6 hospitals had offered PGx tests for no less than five drug-related genes, and only 5 hospitals had covered more than ten drugs, which was a small scale overall. 20.0% of the laboratories did not conduct internal quality control, and 33.3% did not participate in inter-laboratory quality assessment. 46.7% of the practitioners did not receive external training. The primary goal for GTPM was to optimize drug dosage in the 15 hospitals, while the main challenge for GTPM was the implementation cost.

CONCLUSION

Although GTPM in pediatrics has made major progress in Mainland China in recent years, there were still various problems in terms of software, hardware configuration, personnel allocation, business scale, quality control, and result interpretation. This requires joint efforts of health administration, medical insurance departments, researchers, and hospitals to promote and improve GTPM.

摘要

背景

药物遗传学/药物基因组学(PGx)侧重于导致个体之间药代动力学和药物反应异质性的遗传变异,并且有可能预测个体的疗效和/或副作用。本研究旨在调查和了解中国大陆儿童医院个性化药物遗传检测(GTPM)的实施情况。

方法

对中国大陆 31 个省、直辖市和自治区的 50 家儿童医院进行了调查,并进行了统计分析和建议。

结果

问卷回复率为 76.0%(38/50)。本研究纳入了 15 家开展 GTPM 的医院的数据,但仅有 6 家医院提供了不少于 5 个与药物相关的基因的 PGx 检测,仅有 5 家医院涵盖了 10 多种药物,总体规模较小。20.0%的实验室未进行内部质量控制,33.3%未参加实验室间质量评估。46.7%的从业者未接受外部培训。15 家医院开展 GTPM 的主要目标是优化药物剂量,而开展 GTPM 的主要挑战是实施成本。

结论

尽管近年来儿科 GTPM 在中国大陆取得了重大进展,但在软件、硬件配置、人员配置、业务规模、质量控制和结果解释等方面仍存在各种问题。这需要卫生行政部门、医疗保险部门、研究人员和医院共同努力,以促进和改进 GTPM。

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