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基于药物基因组学检测的抑郁障碍患者临床治疗效果:一项随机临床试验。

Effect of pharmacogenomic testing on the clinical treatment of patients with depressive disorder: A randomized clinical trial.

机构信息

Department of Geriatric Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.

Department of Psychiatry, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.

出版信息

J Affect Disord. 2024 Aug 15;359:117-124. doi: 10.1016/j.jad.2024.05.063. Epub 2024 May 16.

Abstract

BACKGROUND

Pharmacotherapy is one of the primary treatment modalities for depression. However, there is considerable variability in the individual response to antidepressant medications. Personalized medicine guided by pharmacogenomic testing may hold promise in addressing this issue.

METHODS

In this study, 665 depressive patients were randomly enrolled into two groups: the pharmacogenomic testing group (n = 333) and the control group (n = 332). In the testing group, participants underwent pharmacogenomic testing, and clinicians customized the treatment plan with the result, while the control group relied solely on clinicians' experience. The primary outcomes were the proportion of remission and response, assessed with Hamilton Depression Rating Scale (HDRS). The secondary outcomes included changes in HDRS scores over time and frequency of adverse drug reactions by the participants.

RESULTS

At week 8, the pharmacogenomic testing group showed significantly higher remission rates (24.0 % v.s. 15.1 %; RR = 1.117; P = 0.007) and response rates (39.3 % v.s. 25.7 %; RR = 1.225; P < 0.001) compared to the control group. By week 12, the pharmacogenomic testing group continued to demonstrate significant advantages in remission (31.0 % v.s. 20.0 %; RR = 1.159; P = 0.003) and response (48.7 % v.s. 37.3 %; RR = 1.224; P = 0.006). Additionally, adverse drug reactions were less frequent in the pharmacogenomic testing group.

LIMITATIONS

This study is not blind to clinicians and it's a single-center study.

CONCLUSIONS

Pharmacogenomic testing-guided drug therapy can provide greater assistance in the treatment of depression.

摘要

背景

药物治疗是抑郁症的主要治疗方式之一。然而,抗抑郁药物的个体反应存在很大差异。基于药物基因组学检测的个体化医学可能有望解决这一问题。

方法

本研究共纳入 665 例抑郁患者,随机分为两组:药物基因组学检测组(n=333)和对照组(n=332)。在检测组中,患者接受药物基因组学检测,临床医生根据检测结果制定治疗方案,而对照组仅依赖于临床医生的经验。主要结局为汉密尔顿抑郁量表(HDRS)评估的缓解率和反应率。次要结局包括 HDRS 评分随时间的变化和患者不良反应的发生频率。

结果

第 8 周时,药物基因组学检测组的缓解率(24.0%比 15.1%;RR=1.117;P=0.007)和反应率(39.3%比 25.7%;RR=1.225;P<0.001)均显著高于对照组。第 12 周时,药物基因组学检测组在缓解(31.0%比 20.0%;RR=1.159;P=0.003)和反应(48.7%比 37.3%;RR=1.224;P=0.006)方面继续表现出显著优势。此外,药物基因组学检测组不良反应的发生频率较低。

局限性

本研究对临床医生不设盲,且为单中心研究。

结论

药物基因组学检测指导的药物治疗可以为抑郁症的治疗提供更大的帮助。

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