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喹硫平治疗阿尔茨海默病患者痴呆的行为和心理症状:一项为期6周的双盲、安慰剂对照研究。

Quetiapine treatment for behavioural and psychological symptoms of dementia in Alzheimer's disease patients: a 6-week, double-blind, placebo-controlled study.

作者信息

Paleacu D, Barak Y, Mirecky I, Mazeh D

机构信息

Neurology Service and Memory Clinic, Abarbanel Mental Health Center, Bat-Yam, Israel.

出版信息

Int J Geriatr Psychiatry. 2008 Apr;23(4):393-400. doi: 10.1002/gps.1892.

Abstract

SETTING

Treating elderly patients with Alzheimer's disease (AD) and behavioral and psychological symptoms of dementia (BPSD) is challenging due to the increased risk of iatrogenic movement disorders with old neuroleptics and the seemingly increasing risk of cardiovascular events with newer atypical agents. Quetiapine is an atypical antipsychotic agent that warrants further investigation.

OBJECTIVES

To assess tolerability, safety, and clinical benefit of quetiapine in AD patients with BPSD.

PARTICIPANTS AND DESIGN

AD patients with BPSD participated in a 6-week randomized, double-blind, placebo-controlled trial. Quetiapine was increased on the basis of clinical response and tolerability. Primary efficacy assessments included the Neuropsychiatric Inventory (NPI) and Clinical Global Impression of Change (CGI-C). Secondary efficacy measures included the Mini-Mental State Examination (MMSE), the Simpson-Angus Scale (SAS) and the Abnormal Involuntary Movement Scale (AIMS).

RESULTS

Forty patients (26 women), mean age 82.2 (SD 6.4) years were enrolled, 27 completed treatment. Median dose of quetiapine was 200 mg/day. Significant NPI total scores reductions (79% for placebo and 68.5% for quetiapine) were observed. The CGI-C score decreased significantly in the quetiapine group (p = 0.009 at 6 weeks) and did not change significantly in the placebo group (p = 0.48). The MMSE, AIMS, SAS scores and adverse events did not differ significantly between the two arms.

CONCLUSIONS

Quetiapine did not significantly improve psychosis scores. It did not cause cognitive and motor deterioration. These results might possibly be due to small sample size.

摘要

背景

治疗老年阿尔茨海默病(AD)患者及伴有痴呆的行为和心理症状(BPSD)具有挑战性,因为使用传统抗精神病药物会增加医源性运动障碍的风险,而使用新型非典型药物则似乎会增加心血管事件的风险。喹硫平是一种非典型抗精神病药物,值得进一步研究。

目的

评估喹硫平治疗伴有BPSD的AD患者的耐受性、安全性和临床疗效。

参与者和设计

伴有BPSD的AD患者参与了一项为期6周的随机、双盲、安慰剂对照试验。根据临床反应和耐受性增加喹硫平剂量。主要疗效评估包括神经精神科问卷(NPI)和临床总体印象变化量表(CGI-C)。次要疗效指标包括简易精神状态检查表(MMSE)、辛普森-安格斯量表(SAS)和异常不自主运动量表(AIMS)。

结果

共纳入40例患者(26例女性),平均年龄82.2(标准差6.4)岁,27例完成治疗。喹硫平的中位剂量为200mg/天。观察到NPI总分显著降低(安慰剂组降低79%,喹硫平组降低68.5%)。喹硫平组的CGI-C评分显著降低(6周时p = 0.009),而安慰剂组无显著变化(p = 0.48)。两组之间的MMSE、AIMS、SAS评分及不良事件无显著差异。

结论

喹硫平未显著改善精神病评分。它未导致认知和运动功能恶化。这些结果可能是由于样本量较小。

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