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焦虑症患者参与临床试验的主观体验和态度

Subjective experience and attitudes towards participation in clinical trials among patients with anxiety disorders.

作者信息

Klein E, Malel D, Zilberman I, Lenox R H

机构信息

Department of Psychiatry, Rambam Medical Center, B. Rappaport Faculty of Medicine, Technion-IIT, Haifa, Israel.

出版信息

Isr J Psychiatry Relat Sci. 1997;34(4):265-9.

PMID:9409083
Abstract

Fifty-two subjects with panic disorder and generalized anxiety disorder were interviewed 12-18 months after they completed an acute treatment study (9-11 weeks) with alprazolam followed by blind and controlled drug discontinuation. Patients were questioned about the severity of their anxiety disorder and degree of functional impairment at the time of follow-up, as well as about their subjective experience as participants in a clinical trial. At the time of follow-up 78% of the patients reported none or minimal anxiety symptoms and 89% had none or only minimal functional deficit, as compared to 100% reporting moderate to severe anxiety symptoms and 57% reporting significant functional deficit before entering the study. Overall, patients felt that the participation in the study was a very positive and beneficial experience and 64% said they would not hesitate to participate in a clinical trial in the future.

摘要

五十二名患有惊恐障碍和广泛性焦虑症的受试者在完成一项使用阿普唑仑的急性治疗研究(9 - 11周)并随后进行盲法和对照药物撤药后12至18个月接受了访谈。患者被问及随访时焦虑症的严重程度和功能损害程度,以及他们作为临床试验参与者的主观体验。随访时,78%的患者报告无或仅有轻微焦虑症状,89%的患者无或仅有轻微功能缺陷,而在进入研究前,100%的患者报告有中度至重度焦虑症状,57%的患者报告有明显功能缺陷。总体而言,患者认为参与该研究是一次非常积极且有益的经历,64%的患者表示他们未来会毫不犹豫地参与临床试验。

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