Will Precision Medicine Move Us beyond Race?
Will Precision Medicine Move Us beyond Race?
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DOI：
10.1056/nejmp1511294
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发表时间：
2016-05-26
期刊：
影响因子：
--
通讯作者：
Royal CD
中科院分区：
文献类型：
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作者：
Bonham VL;Callier SL;Royal CD
长期以来，卫生保健提供者一直在努力解决种族在处方和药物剂量方面的效用。人们普遍认为，自我认定的种族往往与地理祖先相关，地理祖先是基因组变异的主要决定因素，基因组变异可以影响对药物的反应。然而，临床医生面临的挑战是，自我认定的种族不能预测个体患者的基因型或药物反应。基于种族的药物处方过于简单化了祖先、健康、疾病和药物反应的复杂性和相互作用。最终，精准医疗可能会彻底改变我们对种族及其在临床实践中的效用（或缺乏效用）的理解。十年前，美国食品和药物管理局（FDA）批准了第一种基于种族的药物BiDil，这是一种仿制药硝酸异山梨酯和盐酸肼屈嗪的组合，用于治疗自我认定的黑人患者的心力衰竭。这一批准并非基于已知的药物基因组学变异，引发了关于在药物处方和剂量中使用种族的争议，以及批准药物仅用于一个种族群体的科学和伦理理由。1支持者称赞BiDil是迈向个性化医疗的一步，可能会为自我认定的黑人心力衰竭患者提供更好的结果，而批评者认为，种族本身不足以决定谁能或不能从药物中受益，一些可能受益的人可能不会接受它。确定种族忽略了许多影响疾病发展和治疗反应的潜在社会和生物因素。
Health care providers have long struggled with the utility of race in the prescribing and dosing of medications. It is widely accepted that self-identified race often correlates with geographical ancestry, that geographical ancestry is a major determinant of genomic variation, and that genomic variation can influence reactions to drugs. The challenge for clinicians, however, is that self-identified race does not predict the genotype or drug response of an individual patient. Prescribing medications on the basis of race oversimplifies the complexities and interplay of ancestry, health, disease, and drug response. Eventually, precision medicine may revolutionize our understanding of race and its utility (or lack thereof) in clinical practice.A decade ago, the Food and Drug Administration (FDA) approved the first race-based drug, BiDil, a combination of the generic drugs isosorbide dinitrate and hydralazine hydrochloride, as a treatment for heart failure in self-identified black patients. This approval, which was not based on known pharmacogenomic variation, sparked controversy over using race in prescribing and dosing of drugs and the scientific and ethical justifications for approving a drug for only one racial group. 1 Supporters hailed BiDil as a step toward personalized medicine that might provide better outcomes for self-identified black patients with heart failure, while critics contended that race alone is insufficient to determine who can or cannot benefit from the drug and that some people who could benefit might not receive it. Basing the indication for BiDil on self-identified race ignores the many underlying social and biologic factors that influence both development of disease and response to treatment.