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老年住院患者中苯二氮䓬类药物的快速撤药:一项随机双盲、安慰剂对照试验。

Fast withdrawal from benzodiazepines in geriatric inpatients: a randomised double-blind, placebo-controlled trial.

作者信息

Petrovic M, Pevernagie D, Mariman A, Van Maele G, Afschrift M

机构信息

Service of Internal Medicine, University Hospital, Ghent, Belgium.

出版信息

Eur J Clin Pharmacol. 2002 Jan;57(11):759-64. doi: 10.1007/s00228-001-0387-4.

Abstract

OBJECTIVE

We have previously demonstrated that temporary substitution with a low-dose hypnosedative drug may lead to successful withdrawal from chronic benzodiazepine (BZD) use in the majority of patients admitted to a geriatric ward. In the present study, a withdrawal programme was evaluated in which the habitual treatment with BZDs was replaced by either 1 mg lormetazepam or placebo, defining withdrawal success rate, sleep quality and withdrawal symptoms as main outcomes.

METHODS

The target population was geriatric inpatients who had been taking BZDs for at least 3 months. Subjects suffering from mental disorders were excluded. Lormetazepam or placebo were randomly assigned and given in a double-blind fashion. After 1 week, the replacement therapy was discontinued. Subjective estimations of sleep quality and withdrawal symptoms were registered at predefined intervals, four times in a period of 30 days, using standard questionnaires (the Pittsburgh Sleep Quality Index and the Benzodiazepine Withdrawal Symptom Questionnaire, respectively).

RESULTS

The success rate was significantly higher in the lormetazepam substitution group (80% vs 50% in the placebo group, P < 0.05). Both the subjective quality of sleep and withdrawal symptoms were significantly better in the lormetazepam substitution group. Important withdrawal effects were observed in the control group in two patients with a history of chronic alcohol abuse.

CONCLUSIONS

Initial replacement therapy with a low-dose BZD is preferred over placebo, since the latter alternative is associated with worse sleep quality and a lower success rate. Placebo must only be used under medical scrutiny, given the potential for unmasking delirious symptoms, especially in patients with concomitant alcoholism.

摘要

目的

我们之前已经证明,在大多数入住老年病房的患者中,用低剂量催眠镇静药物进行临时替代可能会成功戒除慢性苯二氮䓬(BZD)使用。在本研究中,评估了一项戒断方案,其中用1毫克氯美扎酮或安慰剂替代习惯性使用的BZDs,将戒断成功率、睡眠质量和戒断症状定义为主要结果。

方法

目标人群为服用BZDs至少3个月的老年住院患者。患有精神障碍的受试者被排除。氯美扎酮或安慰剂被随机分配并以双盲方式给药。1周后,停止替代治疗。使用标准问卷(分别为匹兹堡睡眠质量指数和苯二氮䓬戒断症状问卷),在预定间隔时间主观评估睡眠质量和戒断症状,在30天内进行4次。

结果

氯美扎酮替代组的成功率显著更高(80%对安慰剂组的50%,P<0.05)。氯美扎酮替代组的主观睡眠质量和戒断症状均明显更好。在对照组中,两名有慢性酒精滥用史的患者观察到了重要的戒断效应。

结论

与安慰剂相比,首选低剂量BZD进行初始替代治疗,因为后者会导致更差的睡眠质量和更低的成功率。鉴于存在揭示谵妄症状的可能性,尤其是在伴有酒精中毒的患者中,安慰剂必须仅在医学监督下使用。

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