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两剂量阿贝卡尼治疗老年焦虑症的双盲、安慰剂对照试验。

Double-blind, placebo-controlled trial of two doses of abecarnil for geriatric anxiety.

作者信息

Small G W, Bystritsky A

机构信息

Department of Psychiatry, University of California, Los Angeles, USA.

出版信息

J Clin Psychiatry. 1997;58 Suppl 11:24-9.

PMID:9363045
Abstract

We studied the tolerability and efficacy of abecarnil, a new partial benzodiazepine agonist, for short-term relief of anxiety in geriatric patients. After a 1-week placebo lead-in, 182 outpatients (mean +/- SD age = 68.3 +/- 5.8; range, 59-85 years) were randomly assigned in a double-blind, parallel-group design to high-dosage abecarnil (7.5-17.5 mg daily), low-dosage abecarnil (3.0-7.0 mg daily), or placebo for 6 weeks of acute treatment followed by abrupt discontinuation and a 2-week follow-up. During the acute treatment period, the discontinuation rate from adverse events was greater for the group treated with high-dosage abecarnil (44%) than for the groups treated with low-dosage abecarnil (14%) or placebo (12%). The most frequently reported side effects associated with abecarnil were drowsiness and insomnia. For the acute treatment period, low-dosage abecarnil was superior to placebo in reducing anxiety at Weeks 2-4 and 6, and was statistically significantly superior to high-dosage abecarnil at Weeks 4-6. More than half of the placebo group showed at least moderate global improvement at Weeks 3 and 6. One week after abrupt discontinuation of abecarnil, the placebo-treated group had less anxiety than did both groups treated with high-dosage and low-dosage abecarnil. The most commonly reported symptoms of withdrawal were headache and insomnia. These data indicate that abecarnil, at dosages ranging from 3.0 to 7.0 mg daily, is better tolerated and more efficacious for the short-term treatment of anxiety in geriatric patients than are higher dosages of 7.5 to 17.5 mg daily. Abrupt discontinuation of abecarnil at either dosage range causes definite rebound symptoms within the first week after withdrawal. These data also suggest that treatment with placebo offers at least moderate relief of anxiety in many elderly patients.

摘要

我们研究了新型部分苯二氮䓬激动剂阿贝卡尼用于老年患者短期缓解焦虑的耐受性和疗效。在为期1周的安慰剂导入期后,182名门诊患者(平均±标准差年龄 = 68.3±5.8岁;范围为59 - 85岁)采用双盲、平行组设计,被随机分配至高剂量阿贝卡尼组(每日7.5 - 17.5毫克)、低剂量阿贝卡尼组(每日3.0 - 7.0毫克)或安慰剂组,进行为期6周的急性治疗,随后突然停药并进行2周的随访。在急性治疗期间,高剂量阿贝卡尼治疗组因不良事件的停药率(44%)高于低剂量阿贝卡尼治疗组(14%)或安慰剂组(12%)。与阿贝卡尼相关的最常报告的副作用是嗜睡和失眠。在急性治疗期,低剂量阿贝卡尼在第2 - 4周和第6周减轻焦虑方面优于安慰剂,且在第4 - 6周在统计学上显著优于高剂量阿贝卡尼。超过一半的安慰剂组在第3周和第6周显示至少有中度的整体改善。阿贝卡尼突然停药1周后,安慰剂治疗组的焦虑程度低于高剂量和低剂量阿贝卡尼治疗组。最常报告的戒断症状是头痛和失眠。这些数据表明,对于老年患者短期治疗焦虑,每日剂量为3.0至7.0毫克的阿贝卡尼比每日7.5至17.5毫克的较高剂量耐受性更好且更有效。在任一剂量范围内突然停用阿贝卡尼都会在停药后的第一周内引起明确的戒断症状。这些数据还表明,安慰剂治疗在许多老年患者中至少能提供中度的焦虑缓解。

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