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阿普唑仑的安全性与副作用。惊恐障碍伴广场恐惧症的对照研究。

Safety and side-effects of alprazolam. Controlled study in agoraphobia with panic disorder.

作者信息

O'Sullivan G H, Noshirvani H, Başoğlu M, Marks I M, Swinson R, Kuch K, Kirby M

机构信息

Institute of Psychiatry, London.

出版信息

Br J Psychiatry. 1994 Jul;165(1):79-86. doi: 10.1192/bjp.165.1.79.

DOI:10.1192/bjp.165.1.79
PMID:7802851
Abstract

BACKGROUND

The widespread use of benzodiazepines has led to increasing recognition of their unwanted effects. The efficacy of alprazolam and placebo in panic disorder with agoraphobia, and the side-effect and adverse effect profiles of both drug groups were measured.

METHOD

In London and Toronto 154 patients who met DSM-III criteria for panic disorder with agoraphobia were randomised to alprazolam or placebo. Subjects in each drug group also received either exposure or relaxation. Treatment was from weeks 0 to 8 and was then tapered from weeks 8 to 16.

RESULTS

Mean alprazolam dose was 5 mg daily. Compared with placebo subjects, alprazolam patients developed more adverse reactions (21% v. 0%) of depression, enuresis, disinhibition and aggression; and more side-effects, particularly sedation, irritability, impaired memory, weight loss and ataxia. Side-effects tended to diminish during treatment but remained significant at week 8. Despite this, the drop-out rate was low.

CONCLUSIONS

Alprazolam caused side-effects and adverse effects during treatment but many patients were willing to accept these.

摘要

背景

苯二氮䓬类药物的广泛使用已使人们越来越认识到其不良影响。对阿普唑仑和安慰剂治疗伴有广场恐惧症的惊恐障碍的疗效以及两组药物的副作用和不良反应情况进行了测定。

方法

在伦敦和多伦多,将154名符合DSM-III标准的伴有广场恐惧症的惊恐障碍患者随机分为阿普唑仑组或安慰剂组。每个药物组的受试者还接受暴露疗法或放松疗法。治疗从第0周持续到第8周,然后在第8周至第16周逐渐减量。

结果

阿普唑仑的平均日剂量为5毫克。与安慰剂组受试者相比,阿普唑仑组患者出现更多的不良反应(21%对0%),包括抑郁、遗尿、脱抑制和攻击行为;以及更多的副作用,特别是镇静、易怒、记忆力减退、体重减轻和共济失调。副作用在治疗期间趋于减轻,但在第8周时仍很显著。尽管如此,脱落率较低。

结论

阿普唑仑在治疗期间引起了副作用和不良反应,但许多患者愿意接受这些。

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