临床实践中的药物基因组学:巴西药物标签中的生物标记信息
1Division of Clinical Research and Technological Development, National Cancer Institute, Rio de Janeiro, Brazil.
British journal of clinical pharmacology
|September 28, 2025
概括
这次审查发现,与国际标准相比,巴西药物标签中的药物遗传学 (PGx) 信息一致性较差. 在巴西药物插件中标准化PGx数据对于在公共卫生系统中有效实施至关重要.
科学领域:
- 药物遗传学 药物遗传学
- 药物标签 药物标签 药物标签
- 公共卫生政策 公共卫生政策
背景情况:
- 药物遗传学 (PGx) 测试提供药物剂量和疗效的信息.
- 由ANVISA批准的巴西药物包装插件 (bulas) 被审查.
- 根据CPIC的指导方针和PharmGKB的数据,基因药物对的选择是有根据的.
研究的目的:
- 评估ANVISA批准的药物标签中的PGx注释.
- 评估PGx信息与国际监管标准的一致性.
- 在巴西公共卫生系统 (SUS) 中优先考虑PGx实施.
主要方法:
- 基于CPIC和PharmGKB的19种基因药物对的审查.
- 在ANVISA公告中分析PGx注释的存在和分类.
- 使用科恩和弗莱斯的卡帕系数,与选定的监管机构比较ANVISA的PGx水平.
- 在巴西人群中检查PGx生物标志物频率.
主要成果:
- 在10个ANVISA公告中的7个部分中发现了PGx注释.
- 在ANVISA和其他监管机构之间观察到不良一致性 (κ < 0.20).
- 在监管机构中也存在显著的不一致性 (κ = 0.08).
- 巴西的PGx生物标志物频率在<0.1%至10.8%之间,在美洲原住民群体中具有显著的多样性.
结论:
- 目前的ANVISA药物标签显示了碎片化和非标准化的PGx信息.
- 建议在 bulas 中专门设置 PGx 部分,以提高与 SUS 的清晰度和整合性.
- 解决PGx差异对于巴西公平的药物遗传学实施至关重要.
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