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长效注射利培酮联合加兰他敏治疗慢性精神分裂症认知障碍。

Galantamine augmentation of long-acting injectable risperidone for cognitive impairments in chronic schizophrenia.

机构信息

New York University School of Medicine, 530 1st Ave New York, NY 10016, USA.

出版信息

Schizophr Res. 2011 Feb;125(2-3):267-77. doi: 10.1016/j.schres.2010.08.021. Epub 2010 Sep 17.

Abstract

BACKGROUND

Galantamine, a reversible cholinesterase inhibitor with effects on nicotinic receptors, has shown mixed effects on cognitive impairments in patients with schizophrenia. Given these mixed results we examined whether galantamine compared to adjunctive placebo may improve cognitive functions in patients treated concomitantly with a long acting atypical antipsychotic.

METHOD

The parent study was a 52-week double-blind, randomized study of treatment with long-acting injectable risperidone 25mg or 50mg every two weeks. Adjunctive galantamine or placebo treatment was administered from Month 6 to 12. Outcome measures were neurocognitive, psychopathology, social and quality of life functions. Patients were randomized to blinded galantamine up to 24mg/day or matching placebo tablets. All patients were maintained on their randomized long-acting injectable risperidone regimen for the duration of the trial.

RESULTS

32 patients were included in the intent-to-treat analysis. No statistically significant differences were found for Attention Vigilance, Declarative Memory, Processing Speed, Reasoning/Problem Solving, Working Memory domains and the Neurocognitive Composite Score. Group specific analysis showed a statistically significant group interaction (p=0.043) with the Social Cognition domain showing in the galantamine group significantly lower scores at endpoint than placebo patients. The PANSS general psychopathology subscale showed significantly higher scores in the galantamine group at endpoint (p=0.05). ANCOVA model for within treatment group comparisons showed a significant increase of 7.3 points for the total PANSS score for the galantamine group.

CONCLUSION

Galantamine showed no ameliorative effects on cognitive measures in this 6month, double-blind study of patients with schizophrenia treated with an assured and stable antipsychotic medication delivery system. Galantamine may not be an appropriate augmentation agent for cognitive impairments in patients with schizophrenia at the dose used.

摘要

背景

加兰他敏是一种可逆的乙酰胆碱酯酶抑制剂,对烟碱受体也有作用,它在改善精神分裂症患者的认知障碍方面的效果喜忧参半。鉴于这些结果不一,我们研究了加兰他敏与辅助安慰剂相比,是否可能改善同时接受长效非典型抗精神病药物治疗的患者的认知功能。

方法

本研究是一项为期 52 周的双盲、随机研究,评估了每两周注射一次长效利培酮 25mg 或 50mg 的疗效。从第 6 个月到第 12 个月,患者接受加兰他敏或安慰剂辅助治疗。疗效评估指标为神经认知功能、精神病理症状、社会功能和生活质量。患者被随机分配至加兰他敏(最高 24mg/天)或匹配安慰剂片剂的盲法治疗。所有患者在整个试验期间均维持其随机长效注射用利培酮方案。

结果

32 例患者纳入意向治疗分析。在注意力警觉性、陈述性记忆、处理速度、推理/解决问题、工作记忆领域和神经认知综合评分方面,未发现加兰他敏组和安慰剂组之间存在统计学显著差异。分组特定分析显示,社会认知领域存在统计学显著的组间交互作用(p=0.043),加兰他敏组的终点评分显著低于安慰剂组。阳性和阴性症状量表(PANSS)的一般精神病理学子量表显示,加兰他敏组的终点评分显著较高(p=0.05)。针对治疗组内比较的协方差分析模型显示,加兰他敏组的 PANSS 总分显著增加了 7.3 分。

结论

在这项为期 6 个月、针对接受稳定抗精神病药物治疗的精神分裂症患者的双盲研究中,加兰他敏对认知测量指标没有改善作用。在使用的剂量下,加兰他敏可能不是精神分裂症患者认知障碍的合适增效剂。

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