吡拉西坦治疗精神分裂症患者迟发性运动障碍的疗效：一项随机、双盲、安慰剂对照的交叉研究。

Efficacy of piracetam in the treatment of tardive dyskinesia in schizophrenic patients: a randomized, double-blind, placebo-controlled crossover study.

作者信息

Libov Igor, Miodownik Chanoch, Bersudsky Yuly, Dwolatzky Tzvi, Lerner Vladimir

机构信息

Division of Psychiatry, Ministry of Health, Be'er Sheva Mental Health Center; and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er-Sheva, Israel.

出版信息

J Clin Psychiatry. 2007 Jul;68(7):1031-7. doi: 10.4088/jcp.v68n0709.

DOI:10.4088/jcp.v68n0709

PMID:17685739

Abstract

BACKGROUND

Piracetam is a potent antioxidant, a cerebral neuroprotector, a neuronal metabolic enhancer, and a brain integrative agent. More than 20 years ago, an intravenous preparation of piracetam demonstrated an improvement in the symptoms of tardive dyskinesia. The aim of our study was to reexamine the efficacy of piracetam in the treatment of tardive dyskinesia using an oral preparation.

METHOD

The study was conducted at the Be'er Sheva Mental Health Center from May 2003 to December 2004 and involved a 9-week, double-blind, crossover, placebo-controlled trial assessing 40 DSM-IV schizophrenic and schizo-affective patients with DSM-IV-TR tardive dyskinesia. All study subjects received their usual antipsychotic treatment. Initially, subjects were randomly assigned to receive 4 weeks of treatment with either piracetam (4800 mg/day) or placebo. Thereafter, following a washout period of 1 week, they entered the crossover phase of the study for a further 4 weeks. The change in score of the Extrapyramidal Symptom Rating Scale from baseline to the study endpoint was the primary outcome measure.

RESULTS

The mean decrease in score from baseline to endpoint in the clinical global impression subscale in patients treated with piracetam was 1.1 points compared to 0.1 points in the placebo group (p = .004). The mean decrease in the tardive parkinsonism subscale was 8.7 points in patients treated with piracetam and 0.6 points in those on placebo (p = .001). The mean decrease in the tardive dyskinesia subscale was 3.0 points in the piracetam group in contrast to deterioration of condition in the placebo group by -0.2 points (p = .003).

CONCLUSION

Piracetam appears to be effective in reducing symptoms of tardive dyskinesia. The specific mechanism by which piracetam may attenuate symptoms of tardive dyskinesia needs to be further evaluated.

CLINICAL TRIALS REGISTRATION

ClinicalTrials.gov identifier NCT00190008.

摘要

背景

吡拉西坦是一种强效抗氧化剂、脑神经营护剂、神经元代谢增强剂和脑整合剂。20多年前，一种吡拉西坦静脉制剂显示可改善迟发性运动障碍的症状。我们研究的目的是使用口服制剂重新检验吡拉西坦治疗迟发性运动障碍的疗效。

方法

该研究于2003年5月至2004年12月在贝尔谢巴精神卫生中心进行，是一项为期9周的双盲、交叉、安慰剂对照试验，评估40例符合《精神疾病诊断与统计手册》第四版（DSM-IV）标准的精神分裂症和分裂情感性障碍患者，这些患者伴有《精神疾病诊断与统计手册》第四版修订版（DSM-IV-TR）迟发性运动障碍。所有研究对象均接受其常规抗精神病治疗。最初，研究对象被随机分配接受4周的吡拉西坦（4800毫克/天）或安慰剂治疗。此后，经过1周的洗脱期，他们进入研究的交叉阶段，再接受4周治疗。锥体外系症状评定量表从基线到研究终点的评分变化是主要结局指标。

结果

接受吡拉西坦治疗的患者，临床总体印象分量表从基线到终点的平均评分下降1.1分，而安慰剂组为0.1分（p = 0.004）。接受吡拉西坦治疗的患者迟发性帕金森病分量表的平均评分下降8.7分，安慰剂组为0.6分（p = 0.001）。吡拉西坦组迟发性运动障碍分量表的平均评分下降3.0分，而安慰剂组病情恶化0.2分（p = 0.003）。