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使用哌唑嗪对有创伤史的抑郁症患者进行增效治疗:一项随机、双盲、安慰剂对照研究。

Augmentation with prazosin for patients with depression and a history of trauma: A randomised, double-blind, placebo-controlled study.

作者信息

Guo Ping, Xu Yong, Lv Liang, Feng Min, Fang Yu, Cheng Shanfei, Xiao Xiaoqing, Huang Juanjuan, Sheng Wei, Wang Shikai, Chen Huanxin

机构信息

Department of Mental Health, Children's Hospital of Soochow University, Suzhou, Jiangsu, China.

Department of Psychiatry, Huzhou Third Municipal Hospital, The Affiliated Hospital of Huzhou University, Huzhou, Zhejiang, China.

出版信息

Acta Psychiatr Scand. 2025 Feb;151(2):142-151. doi: 10.1111/acps.13763. Epub 2024 Sep 27.

DOI:10.1111/acps.13763
PMID:39340191
Abstract

INTRODUCTION

Depression with a history of trauma often responds poorly to conventional antidepressants and has a poor prognosis. Prazosin, an α1-adrenoceptor blocker, has shown promise in treating post-traumatic stress disorder symptoms, particularly nightmares. Its potential in treating depression with trauma history warrants investigation.

AIMS OF THE STUDY

This randomised, double-blind, placebo-controlled study aimed to investigate the efficacy and tolerability of low-dose prazosin (0.5-1 mg/day) as an augmentation strategy in patients with depression and a history of trauma. We sought to determine if prazosin could provide rapid symptom improvement and enhance overall treatment response compared to placebo in this difficult-to-treat patient population.

METHODS

This randomised, double-blind, placebo-controlled clinical study included 59 patients with first-episode or recurrent unipolar or bipolar depression. After basic antidepressant treatment, they were randomly assigned to a prazosin (0.5-1 mg/day) or placebo group for a 6-week double-blind controlled study. The Montgomery-Åsberg Depression Rating Scale, 17-item Hamilton Depression Scale (HAMD-17), and Hamilton Anxiety Scale (HAMA) were used to evaluate efficacy.

RESULTS

There were no significant differences in the results of the demographic and clinical symptom assessment between the two groups (p > 0.05). The difference between the HAMD-17 and HAMA scores was statistically significant after 3 days of treatment (p < 0.05). The difference in response rate between the two groups was statistically significant after week 4 of treatment (end of week 4, 56.7% vs. 24.1%, p = 0.011; end of week 6, 80.0% vs. 48.3%, p = 0.011). The incidence of adverse reactions in the prazosin and placebo groups was 20.0% and 24.1%, respectively, with no statistically significant differences (p > 0.05); however, the prazosin group had a lower incidence of sleeplessness or nightmares (3.3% vs. 20.7%, p = 0.039) but a higher incidence of orthostatic hypotension (16.7% vs. 0%, p = 0.007). The severity of orthostatic hypotension was mild to moderate.

CONCLUSION

Low-dose prazosin can effectively improve the emotional symptoms of patients with depression and a history of trauma, and the common adverse reaction is mild-to-moderate orthostatic hypotension.

CLINICAL TRIAL REGISTRATION

ChiCTR2200063642.

摘要

引言

有创伤史的抑郁症患者对传统抗抑郁药的反应往往较差,预后不良。哌唑嗪是一种α1肾上腺素能受体阻滞剂,在治疗创伤后应激障碍症状,尤其是噩梦方面已显示出前景。其在治疗有创伤史的抑郁症方面的潜力值得研究。

研究目的

这项随机、双盲、安慰剂对照研究旨在调查低剂量哌唑嗪(0.5 - 1毫克/天)作为增效策略治疗有创伤史抑郁症患者的疗效和耐受性。我们试图确定与安慰剂相比,哌唑嗪是否能在这一难治性患者群体中快速改善症状并增强整体治疗反应。

方法

这项随机、双盲、安慰剂对照临床研究纳入了59例首发或复发性单相或双相抑郁症患者。在进行基本抗抑郁治疗后,他们被随机分配至哌唑嗪(0.5 - 1毫克/天)组或安慰剂组,进行为期6周的双盲对照研究。使用蒙哥马利 - 阿斯伯格抑郁评定量表、17项汉密尔顿抑郁量表(HAMD - 17)和汉密尔顿焦虑量表(HAMA)评估疗效。

结果

两组的人口统计学和临床症状评估结果无显著差异(p > 0.05)。治疗3天后,HAMD - 17和HAMA评分的差异具有统计学意义(p < 0.05)。治疗第4周后两组的缓解率差异具有统计学意义(第4周结束时,56.7%对24.1%,p = 0.011;第6周结束时,80.0%对48.3%,p = 0.011)。哌唑嗪组和安慰剂组的不良反应发生率分别为20.0%和24.1%,无统计学显著差异(p > 0.05);然而,哌唑嗪组失眠或噩梦的发生率较低(3.3%对20.7%,p = 0.039),但体位性低血压的发生率较高(16.7%对0%,p = 0.007)。体位性低血压的严重程度为轻度至中度。

结论

低剂量哌唑嗪可有效改善有创伤史抑郁症患者的情绪症状,常见不良反应为轻度至中度体位性低血压。

临床试验注册号

ChiCTR2200063642

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