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地西泮控释制剂(“Valrelease”)与传统制剂(“安定”)治疗焦虑症患者的多中心全科医生比较研究

Multi-centre general practitioner comparative study of controlled-release ('Valrelease') and conventional ('Valium') forms of diazepam in patients suffering from anxiety.

作者信息

Ward J, Skreta M

机构信息

Medical Information Department, F. Hoffman-La Roche & Co. Ltd., Basle, Switzerland.

出版信息

Curr Med Res Opin. 1988;11(2):87-92. doi: 10.1185/03007998809110451.

Abstract

A multi-centre, double-blind, parallel group study was carried out in 114 patients with an anxiety disorder to compare the effectiveness of diazepam given as 5 mg 3-times daily or as a once-daily 10 mg dose of a controlled-release formulation designed to provide smooth drug concentrations over about 24 hours, without the heavy sedation caused by a high initial peak. Patients were allocated at random to receive one or other dosage regimen for 1 week and treatment could be continued for a further week if necessary. Clinical assessments of response to treatment showed that whilst both formulations were equally effective in providing symptomatic improvement, a much higher proportion of patients on controlled-release diazepam were ready to terminate treatment after 1 week, having attained the desired relief of symptoms. Moreover, as indicated by patient diary records, significantly fewer patients on the controlled-release formulation complained of drowsiness in the morning and evening.

摘要

一项多中心、双盲、平行组研究在114名焦虑症患者中开展,以比较每日3次服用5毫克地西泮与每日1次服用10毫克控释制剂(旨在在约24小时内提供平稳的药物浓度,且无高初始峰引起的严重镇静作用)的有效性。患者被随机分配接受其中一种给药方案1周,如有必要,治疗可再持续1周。对治疗反应的临床评估表明,虽然两种制剂在提供症状改善方面同样有效,但服用控释地西泮的患者中,有更高比例的人在1周后已获得所需症状缓解,准备终止治疗。此外,根据患者日记记录显示,服用控释制剂的患者抱怨早晚嗜睡的人数明显较少。

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