Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: A randomized clinical trial demonstrating clinical utility
Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: A randomized clinical trial demonstrating clinical utility
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DOI：
10.1016/j.jpsychires.2017.09.024
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发表时间：
2018-01-01
影响因子：
4.8
通讯作者：
Lukowiak, Andrew A.
中科院分区：
文献类型：
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作者：
Bradley, Paul;Shiekh, Michael;Lukowiak, Andrew A.
本研究的目的是在一组不同的临床环境中，与标准治疗相比，评价药物遗传学指导治疗对诊断为抑郁和/或焦虑的患者的影响。试验设计遵循前瞻性、随机、受试者和评分者盲法，从精神病学、内科、妇产科和家庭医学专业的临床提供者中招募了685例患者。NeurolDgenetie测试使用10个基因的遗传变异面板，沿着伴随药物，根据基因-药物和药物-药物相互作用为用于治疗抑郁症和焦虑症的40多种药物提供药物管理建议。在初始筛选访视时进行药物遗传学检测，并使用17项汉密尔顿抑郁评定量表（HAM-D17）和汉密尔顿焦虑评定量表（HAM-A）确定基线患者评估。入组和随机化后，将分配至实验组的受试者的药物遗传学结果提供给医生，以指导治疗选择，而对照组受试者根据常规标准治疗。在基线后4周、8周和12周收集HAM-D17和HAM-A评估，以评估治疗选择的疗效。在诊断为抑郁症的患者中，12周时药物遗传学指导组的缓解率（p = 0.001; OR：4.72 [1.93-11.52]）和缓解率（p = 0.02; OR：3.54 [1.27-9.88]）显著高于对照组。此外，实验组中诊断为焦虑的患者在第8周和第12周的HAM-A评分均显示出有意义的改善（分别为p = 0.02和0.02），沿着有更高的应答率（p = 0.04; OR：1.76 [1.03-2.99]）。从这些结果中，我们得出结论，在各种医疗环境中，药物遗传学指导的药物选择显著改善了诊断为抑郁症或焦虑症的患者的结局。(C)2017作者爱思唯尔有限公司出版
The objective of this study was to evaluate the effect of pharmacogenetics-guided treatment on patients diagnosed with depression and/or anxiety, in a diverse set of clinical settings, as compared to the standard of care. The trial design followed a prospective, randomized, subject- and rater-blinded approach enrolling 685 patients from clinical providers specializing in Psychiatry, Internal Medicine, Obstetrics & Gynecology, and Family Medicine. The NeurolDgenetie test uses a genetic variant panel of ten genes, along with concomitant medications, to make medication management recommendations based on gene-drug and drug-drug interactions for over 40 medications used in the treatment of depression and anxiety. Pharmacogenetic testing was performed at the initial screening visit and baseline patient assessments were determined using the 17-item Hamilton Rating Scale for Depression (HAM-D17) and the Hamilton Rating Scale for Anxiety (HAM-A). Following enrollment and randomization, pharmacogenetic results for subjects assigned to the experimental group were provided to physicians to guide treatment selection, while control subjects were treated according to the usual standard of care. HAM-D17 and HAM-A assessments were collected at 4 weeks, 8 weeks, and 12 weeks after baseline to assess the efficacy of therapeutic selection. In patients diagnosed with depression, response rates (p = 0.001; OR: 4.72 [1.93-11.52]) and remission rates (p = 0.02; OR: 3.54 [1.27-9.88]) were significantly higher in the pharmacogenetics-guided group as compared to the control group at 12 weeks. In addition, patients in the experimental group diagnosed with anxiety showed a meaningful improvement in HAM-A scores at both 8 and 12 weeks (p = 0.02 and 0.02, respectively), along with higher response rates (p = 0.04; OR: 1.76 [1.03-2.99]). From these results, we conclude that pharmacogenetic-guided medication selection significantly improves outcomes of patients diagnosed with depression or anxiety, in a variety of healthcare settings. (C) 2017 The Authors. Published by Elsevier Ltd.