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氟西汀给药对二尖瓣脱垂合并广泛性焦虑症患者临床及超声心动图表现的影响:随机临床试验

Effect of Fluoxetine Administration on Clinical and Echocardiographic Findings in Patients with Mitral Valve Prolapse and Generalized Anxiety Disorder: Randomized Clinical Trial.

作者信息

Esfehani Reza Jafarzadeh, Kamranian Homan, Jalalyazdi Majid

机构信息

MD-PHD Student, Department of Medical Genetics, Mashhad University of Medical Sciences, Mashhad, Iran; Medical Genetics Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.

MD. Psychiatrist, Assistant Professor, Department of Psychiatry, Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.

出版信息

Electron Physician. 2017 Jan 25;9(1):3483-3491. doi: 10.19082/3483. eCollection 2017 Jan.

Abstract

BACKGROUND

Mitral valve prolapse (MVP) is accompanied by mental disorders including anxiety, which has similar presentations as MVP. It is hypothesised that treatment of anxiety might reduce the symptoms of MVP.

OBJECTIVE

The aim of this study was to assess the clinical and echocardiographic effects of fluoxetine administration in patients with MVP and anxiety.

METHODS

This randomized clinical trial was conducted on patients with documented MVP and generalised anxiety disorder (GAD) who were referred to Mashhad University of Medical Sciences cardiology clinics, Mashhad, Iran in 2015. Subjects were randomly assigned to intervention group who received propranolol and fluoxetine (both at 10 mg/day) and control group who received 10 mg/day propranolol. Assessments included echocardiography and GAD-7 questionnaire and rating of chest pain, that were performed at baseline and then weekly for 4 weeks. Analysis was performed using the Mann-Whitney U test and Two-way Repeated Measures Analysis of Variance (ANOVA).

RESULTS

Sixty patients (25 male/ 35 female) with a mean age of 22.9 ± 2.5 years were studied in two groups of intervention (n = 30) and control (n = 30). GAD score was significantly higher in the intervention group (17.37 ± 1.61) compared with the control group (14.17 ± 0.83) (p<0.001). No significant difference was observed for changes in left atrium diameter, mitral annular diameter, left ventricular diameter or ejection fraction (p>0.05). Pain severity was reduced significantly more in control group (3.27 ± 1.26) compared to intervention group (2.80 ± 0.85) after treatment (p<0.001).

CONCLUSIONS

This study revealed that the co-administration of fluoxetine and propranolol may not only have no effective in improving echocardiographic changes of MVP but may also aggravate subjective findings of patients with MVP and GAD.

TRIAL REGISTRATION

The trial is registered at the Iranian Clinical Trial Registry (IRCT.ir) with the IRCT identification number IRCT2014102819721N1.

FUNDING

This research has been financially supported by Research Council of Sabzevar University of Medical Sciences.

摘要

背景

二尖瓣脱垂(MVP)常伴有包括焦虑在内的精神障碍,而焦虑的表现与MVP相似。据推测,治疗焦虑可能会减轻MVP的症状。

目的

本研究旨在评估氟西汀对患有MVP和焦虑症患者的临床及超声心动图影响。

方法

本随机临床试验于2015年在伊朗马什哈德医科大学心脏病诊所就诊的有记录的MVP和广泛性焦虑症(GAD)患者中进行。受试者被随机分为干预组(接受普萘洛尔和氟西汀,均为10毫克/天)和对照组(接受10毫克/天普萘洛尔)。评估包括超声心动图、GAD - 7问卷以及胸痛评分,在基线时进行,然后连续4周每周进行一次。采用曼 - 惠特尼U检验和双向重复测量方差分析(ANOVA)进行分析。

结果

两组共研究了60例患者(25例男性/35例女性),平均年龄22.9±2.5岁,干预组(n = 30)和对照组(n = 30)。干预组的GAD评分(17.37±1.61)显著高于对照组(14.17±0.83)(p<0.001)。左心房直径、二尖瓣环直径、左心室直径或射血分数的变化无显著差异(p>0.05)。治疗后,对照组(3.27±1.26)的疼痛严重程度比干预组(2.80±0.85)显著降低更多(p<0.001)。

结论

本研究表明,联合使用氟西汀和普萘洛尔不仅可能对改善MVP的超声心动图变化无效,还可能加重MVP和GAD患者的主观症状。

试验注册

该试验已在伊朗临床试验注册中心(IRCT.ir)注册,注册号为IRCT2014102819721N1。

资金来源

本研究得到了萨卜泽瓦尔医科大学研究委员会的资金支持。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e43e/5308485/25bf7728234f/EPJ-09-3483-g001.jpg

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