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药物遗传学指导治疗对神经精神疾病患者的临床影响:一项随机对照试验。

Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial.

作者信息

Olson Marilyn C, Maciel Alejandra, Gariepy Jean Francois, Cullors Ali, Saldivar Juan-Sebastian, Taylor David, Centeno Joel, Garces Jorge A, Vaishnavi Sandeep

机构信息

AltheaDx, 10578 Science Center Dr, San Diego, CA 92121.

AltheaDx, San Diego, California, USA.

出版信息

Prim Care Companion CNS Disord. 2017 Mar 16;19(2). doi: 10.4088/PCC.16m02036.

DOI:10.4088/PCC.16m02036
PMID:28314093
Abstract

OBJECTIVE

Pharmacogenetic testing holds promise as a personalized medicine tool by permitting individualization of pharmacotherapy in accordance with genes influencing therapeutic response, side effects, and adverse events. The authors evaluated the effect on outcomes for patients diagnosed with neuropsychiatric disorders of pharmacogenetics (PGx)-guided treatment compared to usual standard of care.

METHODS

This was a prospective, randomized study of 237 patients at an outpatient community-based psychiatric practice conducted between April 2015 and October 2015. Baseline patient assessments and a buccal swab were collected for pharmacogenetic testing at study initiation. For the experimental group, PGx results were provided to the clinicians as guides to treatment. Control subjects were treated according to the usual standard of care with no clinician reference to their PGx results. Neuropsychiatric Questionnaire (NPQ) and Symbol Digit Coding Test (SDC) scores and adverse drug events, hospitalizations, and medication information were collected at 30, 60, and 90 days.

RESULTS

More than half (53%) of patients in the control group reported at least 1 adverse drug event compared to 28% of patients with PGx-guided medication management (P = .001). NPQ and SDC scores improved for both groups, but no statistical difference in efficacy as measured by these assessments was observed within the 90-day observation period.

CONCLUSIONS

Pharmacogenetic testing may facilitate psychiatric drug therapy with greater tolerability and similar efficacy compared to standard of care.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02411123​​.

摘要

目的

药物遗传学检测有望成为一种个性化医疗工具,它能够根据影响治疗反应、副作用和不良事件的基因来实现药物治疗的个体化。作者评估了与常规标准治疗相比,药物遗传学(PGx)指导治疗对诊断为神经精神疾病患者的治疗效果。

方法

这是一项前瞻性随机研究,于2015年4月至2015年10月在一家社区门诊精神科诊所对237名患者进行。在研究开始时收集患者的基线评估和颊拭子进行药物遗传学检测。对于实验组,将PGx结果提供给临床医生作为治疗指导。对照组按照常规标准治疗,临床医生不参考其PGx结果。在第30、60和90天收集神经精神问卷(NPQ)和符号数字编码测试(SDC)分数以及药物不良事件、住院情况和用药信息。

结果

对照组超过一半(53%)的患者报告至少发生1次药物不良事件,而PGx指导药物管理组的这一比例为28%(P = 0.001)。两组的NPQ和SDC分数均有所改善,但在90天观察期内,通过这些评估测量的疗效没有统计学差异。

结论

与标准治疗相比,药物遗传学检测可能有助于提高精神科药物治疗的耐受性,并具有相似的疗效。

试验注册

ClinicalTrials.gov标识符:NCT02411123​​。

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