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阿吡坦治疗焦虑症的作用:欧洲数据综述

On the therapeutic action of alpidem in anxiety disorders: an overview of the European data.

作者信息

Morselli P L

机构信息

Department of Clinical Research, Synthélabo Recherche, Paris, France.

出版信息

Pharmacopsychiatry. 1990 May;23 Suppl 3:129-34. doi: 10.1055/s-2007-1014549.

Abstract

This review analyzes the available data on the therapeutic activity of alpidem in various anxiety syndromes. Up to now, 17 studies have been completed in Europe, dealing with a total population of more than 1500 patients suffering from either chronic (n = 987) or situational anxiety (n = 400). In a series of five placebo-controlled double-blind studies in situations of stress-induced anxiety (gastroscopy, minor surgery, cardiac catheterization), the therapeutic efficacy of alpidem was evident in 53% of the patients and significantly (P less than 0.001) superior to that of placebo (30%). In more than 400 patients suffering from generalized anxiety or adjustment disorders with anxious mood, six double-blind studies run against placebo or reference drug over a period of two to three weeks indicated an anxiolytic effect superior (P less than 0.01) to that of placebo and comparable to that of reference drugs (DZ, LZP, CZP). A long-term (6-12 months) open-label study conducted on a population of more than 300 patients suffering from chronic anxiety indicated that no tachyphylaxis occurs during prolonged treatment and that following abrupt drug discontinuation no withdrawal or rebound phenomena are observed. Globally, alpidem appears to be well tolerated with a minimum of dose-related, sedative effects (6-7% of the cases) and no effects on memory or cognitive functions. Four studies conducted specifically in an elderly population (n = 191) indicate that the elderly patients do not show an increased sensitivity to alpidem. On the contrary, as in adults, the anxiolytic effect was not accompanied by a reduction in performance or in cognitive functions nor by withdrawal reactions when treatment was discontinued.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

本综述分析了阿普地尔在各种焦虑综合征中治疗活性的现有数据。截至目前,欧洲已完成17项研究,涉及的患者总数超过1500例,这些患者患有慢性焦虑(n = 987)或情境性焦虑(n = 400)。在一系列针对应激性焦虑情况(胃镜检查、小手术、心导管插入术)的五项安慰剂对照双盲研究中,53%的患者阿普地尔治疗有效,且显著优于安慰剂(30%)(P < 0.001)。在400多名患有广泛性焦虑或伴有焦虑情绪的适应障碍患者中,六项针对安慰剂或对照药物进行的双盲研究,为期两到三周,结果表明阿普地尔的抗焦虑作用优于安慰剂(P < 0.01),且与对照药物(地西泮、氯氮卓、氯硝西泮)相当。一项针对300多名慢性焦虑患者进行的长期(6 - 12个月)开放标签研究表明,长期治疗期间未出现快速耐受性,突然停药后也未观察到戒断或反跳现象。总体而言,阿普地尔耐受性良好,与剂量相关的镇静作用最少(6 - 7%的病例),对记忆或认知功能无影响。四项专门针对老年人群(n = 191)进行的研究表明,老年患者对阿普地尔并未表现出更高的敏感性。相反,与成年人一样,抗焦虑作用并未伴随着治疗期间表现或认知功能的下降,停药时也未出现戒断反应。(摘要截选于250词)

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