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别嘌醇作为锂盐和氟哌啶醇治疗急性躁狂症患者的辅助药物:一项双盲、随机、安慰剂对照试验。

Allopurinol as an adjunct to lithium and haloperidol for treatment of patients with acute mania: a double-blind, randomized, placebo-controlled trial.

作者信息

Akhondzadeh Shahin, Milajerdi Mehdi Rafiee, Amini Homayoun, Tehrani-Doost Mehdi

机构信息

Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Bipolar Disord. 2006 Oct;8(5 Pt 1):485-9. doi: 10.1111/j.1399-5618.2006.00363.x.

DOI:10.1111/j.1399-5618.2006.00363.x
PMID:17042886
Abstract

OBJECTIVE

Allopurinol, a hypouricemic agent, has been shown to present therapeutic effects in mania associated with hyperuricemia. This study assessed the efficacy and safety of risperidone as an adjunctive agent to lithium and haloperidol for the treatment of acute mania in hospitalized bipolar patients.

METHODS

Eighty-two patients aged between 18 and 49 were eligible to participate, as they met the DSM-IV criteria for a current manic episode, on the basis of a clinical interview by two academician psychiatrists. In addition, a score of at least 20 points on the Young Mania Rating Scale was required representing at least a moderate-to-severe mania. Forty-one patients were randomly allocated to lithium (1-1.2 mEq/L) + haloperidol (10 mg/day) + allopurinol (300 mg/day) (group A) or lithium (1-1.2 mEq/L) + haloperidol (10 mg/day) + placebo (group B) for an 8-week, double-blind, placebo-controlled study. Patients were assessed by a third-year resident of psychiatry at baseline and at 7, 14, 28, 42, and 56 days after the medication started. The mean decrease in the Young Mania Rating Scale score from baseline was used as the main outcome measure of response of mania to treatment. The extrapyramidal symptoms were assessed using the Extrapyramidal Symptoms Rating Scale (ESRS). Side effects were systematically recorded throughout the study and were assessed using a checklist.

RESULTS

Young Mania Rating Scale scores improved with allopurinol. The difference between the two protocols was significant as indicated by the effect of the group, the between-subjects factor (F = 5.22, df = 1, p = 0.008). The mean ESRS scores for the placebo group were higher than the allopurinol group. However, the differences were not significant over the trial. The difference between the two groups in the frequency of side effects was not significant except for agitation that was more often in the placebo group.

CONCLUSIONS

The efficacy of allopurinol to obtain a greater improvement in patients with mania seems to support the purinergic dysfunction in mania.

摘要

目的

别嘌醇作为一种降尿酸药物,已被证明对伴有高尿酸血症的躁狂症具有治疗作用。本研究评估了利培酮作为锂盐和氟哌啶醇辅助药物治疗住院双相情感障碍患者急性躁狂症的疗效和安全性。

方法

82名年龄在18至49岁之间的患者符合参与条件,他们基于两名院士级精神科医生的临床访谈,满足当前躁狂发作的DSM-IV标准。此外,杨氏躁狂量表得分至少20分,代表至少中度至重度躁狂。41名患者被随机分配至锂盐(1 - 1.2 mEq/L)+氟哌啶醇(10 mg/天)+别嘌醇(300 mg/天)组(A组)或锂盐(1 - 1.2 mEq/L)+氟哌啶醇(10 mg/天)+安慰剂组(B组),进行为期8周的双盲、安慰剂对照研究。在基线以及用药开始后第7、14、28、42和56天,由一名精神科三年级住院医师对患者进行评估。杨氏躁狂量表得分较基线的平均下降幅度用作躁狂症对治疗反应的主要结局指标。使用锥体外系症状评定量表(ESRS)评估锥体外系症状。在整个研究过程中系统记录副作用,并使用检查表进行评估。

结果

别嘌醇使杨氏躁狂量表得分得到改善。如组效应、受试者间因素所示,两种方案之间的差异具有统计学意义(F = 5.22,自由度 = 1,p = 0.008)。安慰剂组的平均ESRS得分高于别嘌醇组。然而,在整个试验过程中差异不显著。除了安慰剂组更常出现激越外,两组在副作用频率上的差异不显著。

结论

别嘌醇在躁狂症患者中取得更大改善的疗效似乎支持躁狂症中的嘌呤能功能障碍。

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