本妥昔林治疗双相情感障碍 I/II 期难治性抑郁症患者的疗效:概念验证、随机、双盲、安慰剂对照试验。

IF 3.5 3区 医学 Q2 NEUROSCIENCES
Tavgah Ahmed Merza Mohammad , Talar Ahmed Merza Mohammad , Teshk Nouri Shawis
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引用次数: 0

摘要

背景:免疫调节失调在抑郁症病理生理学中可能起一定作用,根据研究,免疫拮抗剂可以改善耐药双相抑郁症(TRD)患者的抑郁症状:目的:评估抗炎药物戊乙茶碱(PTX)对TRD双相抑郁I/II成人受试者的抗抑郁作用:这项为期 12 周、随机、双盲、安慰剂对照、平行组试验在伊拉克埃尔比勒的 Hawler 精神病医院和私人诊所进行,共有 60 人参加。根据 DSM-5 标准,确认参与者符合双相抑郁 I/II 级标准。数据采用修正的意向治疗分析法进行分析:结果:两组患者的汉密尔顿抑郁评定量表-17(HAM-D-17)得分无明显差异(χ2=1.9,P=.48),时间×治疗交互作用无明显差异(χ2=7.1,P=.54)。然而,两组患者的 HAM-D-17 评分从起点到终点均有显著的时间效应(χ2= 2.11,P=.002)。此外,研究还发现时间×治疗×CRP存在明显的交互作用(χ2=3.1,P=0.016),其中CRP>7.1mg/L的PTX治疗受试者的HAM-D-17评分降低幅度更大。PTX组与安慰剂组的反应率差异未达到显著性水平(χ2=0.84,P=0.43)。此外,在第12周时,PTX组血清中的TNF-α、CRP和IL-6浓度明显降低(P=.007、.04和结论):目前的概念验证研究发现,就TRD双相情感障碍患者的总体抗抑郁效果而言,PTX并不优于安慰剂。然而,在治疗前炎症特征较高的受试者亚群中,PTX可改善抑郁情绪:临床试验注册号:NCT05324735。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy of pentoxifylline for the treatment of bipolar I/II patients with treatment-resistant depression: A proof-of-concept, randomized, double-blind, placebo-controlled trial

Background

Immune dysregulation can play a role in depression pathophysiology, and immunological antagonists can improve depressive symptoms in treatment-resistant bipolar depression (TRD) patients according to studies.

Objective

To evaluate the anti-depressant effects of the anti-inflammatory drug, pentoxifylline (PTX) in TRD bipolar I/II adult subjects.

Methods

This 12-week, randomized, double-blind, placebo-controlled, parallel-group trial of 60 participants was conducted at Hawler Psychiatric Hospital and Private Clinic in Erbil, Iraq. Participants were confirmed as being qualified for bipolar I/II depression based on DSM-5 criteria. Data were analyzed using modified intent-to-treat analysis.

Results

There were no significant differences between the two groups in Hamilton Rating Scale for Depression-17 (HAM-D-17) scores (χ2=1.9, P =.48) or a significant time × treatment interaction (χ2=7.1, P=.54). Nevertheless, a significant effect of time was observed with both groups’ reduction in HAM-D-17 scores from the start to the endpoint (χ2= 2.11, P=.002). Besides, a significant time × treatment × CRP interaction was found (χ2=3.1, P=0.016), where there was more reduction in HAM-D-17 score in PTX-treated subjects with CRP> 7.1 mg/L. The response rate difference between PTX and the placebo group did not reach a significance level (χ2=0.84, p=0.43). Furthermore, serum concentrations of TNF-α, CRP, and IL-6 significantly reduced at week 12 in the PTX group (P=.007,.04, and <.001, respectively).

Conclusion

The current proof of concept study found that in terms of overall anti-depressant effectiveness in bipolar patients with TRD, PTX is not superior to placebo. However, it may improve depressive mood in a subpopulation of subjects with a higher pretreatment inflammatory profile.

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来源期刊
Brain Research Bulletin
Brain Research Bulletin 医学-神经科学
CiteScore
6.90
自引率
2.60%
发文量
253
审稿时长
67 days
期刊介绍: The Brain Research Bulletin (BRB) aims to publish novel work that advances our knowledge of molecular and cellular mechanisms that underlie neural network properties associated with behavior, cognition and other brain functions during neurodevelopment and in the adult. Although clinical research is out of the Journal''s scope, the BRB also aims to publish translation research that provides insight into biological mechanisms and processes associated with neurodegeneration mechanisms, neurological diseases and neuropsychiatric disorders. The Journal is especially interested in research using novel methodologies, such as optogenetics, multielectrode array recordings and life imaging in wild-type and genetically-modified animal models, with the goal to advance our understanding of how neurons, glia and networks function in vivo.
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