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首页> 外文期刊>Journal of breath research >Point-of-care companion diagnostic tests for personalizing psychiatric medications: fulfilling an unmet clinical need
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Point-of-care companion diagnostic tests for personalizing psychiatric medications: fulfilling an unmet clinical need

机译：个性化精神病药物的护理点伴治疗试验：满足未满足的临床需求

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Over the last decade stable isotope-labeled substrates have been used as probes for rapid, point-ofcare, non-invasive and user-friendly phenotype breath tests to evaluate activity of drug metabolizing enzymes. These diagnostic breath tests can potentially be used as companion diagnostics by physicians to personalize medications, especially psychiatric drugs with narrow therapeutic windows, to monitor the progress of disease severity, medication efficacy and to study in vivo the pharmacokinetics of xenobiotics. Several genotype tests have been approved by the FDA over the last 15 years for both cytochrome P450 2D6 and 2C19 enzymes, however they have not been cleared for use in personalizing medications since they fall woefully short in identifying all non-responders to drugs, especially for the CYP450 enzymes. CYP2D6 and CYP2C19 are among the most extensively studied drug metabolizing enzymes, involved in the metabolism of approximately 30% of FDA-approved drugs in clinical use, associated with large individual differences in medication efficacy or tolerability essentially due to phenoconversion. The development and commercialization via FDA approval of the non-invasive, rapid (<60 min), in vivo, phenotype diagnostic breath tests to evaluate polymorphic CYP2D6 and CYP2C19 enzyme activity by measuring exhaled ~(13)CO_2 as a biomarker in breath will effectively resolve the currently unmet clinical need for individualized psychiatric drug therapy. Clinicians could personalize treatment options for patients based on the CYP2D6 and CYP2C19 phenotype by selecting the optimal medication at the right initial and subsequent maintenance dose for the desired clinical outcome (i.e. greatest efficacy and minimal side effects).
机译：在过去的十年中，稳定的同位素标记的基材已被用作快速，关节，非侵入性和用户友好的表型呼气测试的探针，以评估药物代谢酶的活性。这些诊断呼吸测试可能被医生用作伴侣诊断，以个性化药物，特别是具有狭窄治疗窗的精神病药物，以监测疾病严重程度，药物疗效以及体内研究的疾病的进展。 FDA在过去的15年里获得了几种基因型测试，以适用于细胞色素P450 2D6和2C19酶，然而它们尚未被清除用于个性化药物，因为它们在令人窒息的情况下令人讨厌地缩短了诸如药物的所有非响应者，特别是CYP450酶。 CYP2D6和CYP2C19是最广泛地研究的药物代谢酶，参与临床用途的约30％的FDA批准的药物的代谢，与苯氧化能转化基本上基本上与药物疗效或耐受性的大量差异相关。通过FDA批准非侵入性，快速（<60分钟），体内，表型诊断呼气试验的开发和商业化，以评估多晶型CYP2D6和CYP2C19酶活性，通过测量呼出〜（13）CO_2作为生物标志物有效有效解决目前未满足的临床需要个性化精神病药物治疗。临床医生可以通过在正确的初始和随后的维持剂量中选择最佳用药来个性化基于CYP2D6和CYP2C19表型来个性化治疗方案，以获得所需的临床结果（即最大的疗效和最小副作用）。

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