Implementation of pharmacogenomics into the clinical practice of therapeutics: issues for the clinician and the laboratorian

Implementation of pharmacogenomics into the clinical practice of therapeutics: issues for the clinician and the laboratorian
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DOI:
10.2217/pme.09.1
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发表时间:
2009-05-01
影响因子:
2.3
通讯作者:
Yeo, Kiang-Teck J.
Yeo, Kiang-Teck J.
中科院分区:
医学4区
文献类型:
--
作者:
Wu, Alan H. B.;Babic, Nikolina;Yeo, Kiang-Teck J.

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药物基因组学承诺通过向适当的患者提供正确的药物和剂量来改善治疗护理。尽管人们对个体化医疗产生了广泛的兴趣,但临床药物基因组学的实施却进展缓慢。临床医生面临的主要问题是缺乏证据表明药物基因组学检测可以改善临床结局,并且检测具有成本效益。只有少数随机临床试验比较药物基因组学测试与标准协议已进行。现有的少数研究要么动力不足,要么只证明了适度的益处。然而,如果临床决定治疗选择和剂量,药物基因组学检测可能是合理的。临床实验室(负责提供药物基因组学服务)需要考虑的问题包括美国FDA批准的检测的可用性、缺乏报销代码、基因分型准确性的需求以及寻找临床专业知识来解释实验室结果的需求。从临床实验室的角度来看,当这些障碍被解决或最小化时,可以更好地实施测试。临床药物基因组学也为不同层次的转化研究和教学提供了一个新的领域。
Pharmacogenomics promises to improve therapeutic care by providing the right drug and dosage to the appropriate patient. Despite widespread interest in personalized medicine, the implementation of clinical pharmacogenomics has been slow. The major issue for clinicians is the lack of evidence that pharmacogenomic testing improves clinical outcomes and that testing is cost-effective. Only a few randomized clinical trials comparing pharmacogenomic testing with standard protocols have been conducted. The few studies that are available have either been underpowered or demonstrated only modest benefits. Nevertheless, if clinical decisions are made regarding therapeutic selection and dosing, pharmacogenomic testing may be justified. Issues for the clinical laboratories (who are responsible for providing pharmacogenomic services) to consider, include the availability of US FDA-cleared tests, the absence of reimbursement codes, the need for genotyping accuracy and the need to find clinical expertise to interpret laboratory results. From the clinical laboratory perspective, testing can be better implemented when these barriers are resolved or minimized. Clinical pharmacogenomics also offers a new field for translational research and teaching at various levels.