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评论:在临床决策中是否应考虑药物基因组学证据?以选择心血管药物为例。

Commentary: Should Pharmacogenomic Evidence Be Considered in Clinical Decision Making? Focus on Select Cardiovascular Drugs.

机构信息

Department of Pharmacy Practice, College of Pharmacy, Natural and Health Sciences, Manchester University, Fort Wayne, Indiana.

Department of Pharmaceutical Sciences, College of Pharmacy, Ferris State University, Grand Rapids, Michigan.

出版信息

Pharmacotherapy. 2017 Sep;37(9):1005-1013. doi: 10.1002/phar.1979. Epub 2017 Aug 15.

Abstract

Despite advances in technology and guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC) that focus on how to use pharmacogene test results, hurdles remain that have delayed the widespread application of pharmacogenomics in clinical practice. These hurdles include a lack of prospective randomized controlled trials to address the utility of pharmacogenomics on clinical outcomes, what the clinical algorithm for pharmacogenomics should be, and whether pharmacogenomics is cost-effective. However, the implementation of clinical practice guidelines, such as those from professional organizations, is commonplace and often termed the application of evidence-based medicine. Here, we draw an analogy between the evidence supporting many commonly cited clinical practice guidelines and U.S. Food and Drug Administration-approved labeling recommendations and the evidence supporting recommendations from CPIC. Although many clinical practice guideline recommendations are supported by the results of randomized controlled clinical trials, we cite examples of common clinical practices that are supported by levels and types of evidence similar to the evidence supporting many of the CPIC recommendations. Specifically, we discuss clinical recommendations for guidance related to drug-drug interactions, drug-gene interactions, therapeutic range selection, and dosage adjustments based on patient-specific factors within the context of a select set of cardiovascular therapeutic topics.

摘要

尽管在技术方面取得了进展,临床药物遗传学实施联合会 (CPIC) 也制定了相关指南,重点介绍如何使用药物基因检测结果,但仍存在一些障碍,阻碍了药物基因组学在临床实践中的广泛应用。这些障碍包括缺乏前瞻性随机对照试验来解决药物基因组学对临床结果的实用性、药物基因组学的临床算法应该是什么,以及药物基因组学是否具有成本效益。然而,临床实践指南的实施(例如来自专业组织的指南)是很常见的,通常被称为循证医学的应用。在这里,我们将支持许多常见引用的临床实践指南的证据与支持 CPIC 建议的证据进行类比。尽管许多临床实践指南建议都得到了随机对照临床试验结果的支持,但我们也引用了一些常见临床实践的例子,这些实践得到了与支持 CPIC 许多建议相似的证据水平和类型的支持。具体来说,我们讨论了与药物相互作用、药物基因相互作用、治疗范围选择和基于患者特定因素的剂量调整相关的指导临床建议,这些建议是在一组选定的心血管治疗主题背景下提出的。

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