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巴氯芬与可乐定治疗阿片类药物戒断反应的副作用比较:一项双盲随机对照试验

Baclofen versus clonidine in the treatment of opiates withdrawal, side-effects aspect: a double-blind randomized controlled trial.

作者信息

Ahmadi-Abhari S A, Akhondzadeh S, Assadi S M, Shabestari O L, Farzanehgan Z M, Kamlipour A

机构信息

Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Avenue, Tehran 13334, Iran.

出版信息

J Clin Pharm Ther. 2001 Feb;26(1):67-71. doi: 10.1046/j.1365-2710.2001.00325.x.

Abstract

OBJECTIVE

Baclofen is known for the alleviation of signs and symptoms of spasticity. Reports from our previous study have suggested that it may be at least as effective as clonidine in the management of physical symptoms of opiate withdrawal syndromes and superior to clonidine in the management of mental symptoms. We now report on a randomized double-blind comparison of baclofen vs. clonidine in view of side-effects profile.

METHODS

A total of 62 opiates addicts were randomly assigned to treatment with baclofen or clonidine during a 14-day, double-blind clinical trial. All patients met the DSM IV criteria for opioid dependence. Maximum daily doses were 40 mg for baclofen and 0.8 mg for clonidine. This trial medication was given three times per day in divided doses. The severity of side-effects was measured in days 0, 1, 2, 3, 4, 7 and 14.

RESULTS

There was no significant difference between two treat7ments in terms of retention in treatment (dropout) and overall side-effect. Nevertheless, significantly more problems relating to hypotension were encountered with subjects on clonidine.

CONCLUSION

We conclude that, the low incidence of hypotension with baclofen suggests that the drug may be suitable for outpatient ambulatory treatment of withdrawal from opiates.

摘要

目的

巴氯芬以缓解痉挛的体征和症状而闻名。我们之前研究的报告表明,在治疗阿片类药物戒断综合征的身体症状方面,它可能至少与可乐定一样有效,而在治疗精神症状方面优于可乐定。鉴于副作用情况,我们现在报告巴氯芬与可乐定的随机双盲比较。

方法

在一项为期14天的双盲临床试验中,共有62名阿片类药物成瘾者被随机分配接受巴氯芬或可乐定治疗。所有患者均符合DSM-IV阿片类药物依赖标准。巴氯芬的最大日剂量为40毫克,可乐定为0.8毫克。试验药物每天分三次给药。在第0、1、2、3、4、7和14天测量副作用的严重程度。

结果

在治疗保留率(退出率)和总体副作用方面,两种治疗方法之间没有显著差异。然而,服用可乐定的受试者出现的与低血压相关的问题明显更多。

结论

我们得出结论,巴氯芬引起低血压的发生率低,表明该药物可能适用于门诊阿片类药物戒断的非卧床治疗。

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