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溴西泮与普拉西泮治疗非精神病性焦虑的比较双盲研究

[Comparative double-blind study of bromazepam versus prazepam in non-psychotic anxiety].

作者信息

Guelfi J D, Lancrenon S, Millet V

机构信息

Clinique des Maladies Mentales et de l'Encéphale, Hôpital Sainte-Anne, Paris.

出版信息

Encephale. 1993 Sep-Oct;19(5):547-52.

PMID:8306923
Abstract

The efficacy of bromazepam and prazepam for the different components of anxiety: inhibition, asthenia and somatisation is evaluated in a multi-centric, comparative and randomised study, conducted as double blind and in parallel groups in 159 adult patients showing a manifest anxiety according to the F.D.A. criteria. After a 7 day wash-out period, the patients receive either bromazepam in a 12 mg/d dose or prazepam in a 40 mg/d dose, over 4 weeks (D0-D28), then in a decreasing dose from D28 to D43; follow-up is carried out using the anxious inhibition scale W.P.2, auto-questionnaire A.D.A., the Hamilton anxiety scale and the Tyrer questionnaire (benzodiazepine withdrawal symptoms questionnaire). Patients are evaluated seven times during the study: at day 7 for inclusion, day 0 for randomisation, then day 7 and day 14 for following visits, at day 28 for efficacy and tolerance evaluation, and at day 50 for utilisation and withdrawal evaluation. The major efficacy criteria are the evolution of inhibition, asthenia and somatisation as compounds of anxiety respectively evaluated by W.P.2 scale, asthenic partial score of autoquestionnaire A.D.A. and somatic partial score of Hamilton anxiety scale. The analysis of results don't show any significant difference between the two groups on the evolution of the components asthenia and inhibition. However the evolution of the somatic component clearly makes a significant difference in favour of bromazepam. There is also a significant difference in terms of global anxiolytic action efficacy, in favour of bromazepam.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

在一项多中心、比较性和随机研究中,对159名根据美国食品药品监督管理局(FDA)标准表现出明显焦虑的成年患者进行双盲平行分组,评估溴西泮和普拉西泮对焦虑不同成分(抑制、乏力和躯体化)的疗效。经过7天的洗脱期后,患者在4周内(D0 - D28)接受12毫克/天剂量的溴西泮或40毫克/天剂量的普拉西泮治疗,然后从D28到D43逐渐减量;使用焦虑抑制量表W.P.2、自评问卷A.D.A.、汉密尔顿焦虑量表和泰勒问卷(苯二氮䓬撤药症状问卷)进行随访。在研究期间对患者进行7次评估:第7天为纳入期,第0天为随机分组,然后第7天和第14天为随访,第28天进行疗效和耐受性评估,第50天进行用药和撤药评估。主要疗效标准是分别通过W.P.2量表评估的焦虑成分抑制、乏力和躯体化的变化,自评问卷A.D.A.的乏力部分得分以及汉密尔顿焦虑量表的躯体部分得分。结果分析显示,两组在乏力和抑制成分的变化上没有显著差异。然而,躯体成分的变化明显有利于溴西泮。在整体抗焦虑作用疗效方面也存在显著差异,有利于溴西泮。(摘要截取自250字)

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