Rainer M, Haushofer M, Pfolz H, Struhal C, Wick W
Psychiatric Department and Memory-Clinic, Danube Hospital, Langobardenstrasse 122, A-1220 Vienna, Austria.
Eur Psychiatry. 2007 Sep;22(6):395-403. doi: 10.1016/j.eurpsy.2007.03.001. Epub 2007 May 4.
In this study we directly compared the efficacy and tolerability of the atypical antipsychotics quetiapine and risperidone in elderly patients with dementia and symptoms of disturbed perception, thought content, mood or behaviour (behavioural and psychological symptoms of dementia-BPSD).
We conducted an 8-week, rater-blinded, randomised study of 72 outpatients (55-85 years) with BPSD (assessed by NPI baseline score), who received flexibly-dosed quetiapine (50-400 mg/day) or risperidone (0.5-2 mg/day). Primary efficacy measure: Neuropsychiatric Inventory (NPI) Parts 1 and 2; secondary efficacy measures: Clinical Global Impression (CGI), Cohen-Mansfield Agitation Inventory (CMAI), Mini-Mental State Examination (MMSE), Age-adjusted concentration test (AKT). Safety evaluations included the incidence of extrapyramidal symptoms (EPS) and adverse events (AEs).
Sixty-nine of 72 patients were evaluable for efficacy (72 were evaluated for safety), 4 patients discontinued (3 due to AEs: quetiapine 2, risperidone 1; 1 lost to follow-up). Sixty-five patients received quetiapine (n=34; mean dose 77+/-40 mg/day) or risperidone (n=31; mean dose 0.9+/-0.3 mg/day). There was no significant difference between treatments on NPI scores; within treatment groups, NPI scores decreased significantly from baseline to Week 8 (P<or=0.05 vs. baseline). Most patients (quetiapine arm 67.6%, risperidone arm 71.0%) experienced clinical improvement (CGI-Improvement scores); both agents reduced agitation (CMAI scores); and there was no cognitive impairment (MMSE and AKT scores). There were no significant differences between treatments in any safety measures, including EPS. Four patients experienced serious AEs (quetiapine arm 3; risperidone arm 1); none were considered treatment-related by the study investigator. There were no cerebrovascular AEs or deaths.
Quetiapine or risperidone, at low doses, were equally effective and generally well tolerated (including no cognitive impairment) in the treatment of BPSD in elderly patients.
在本研究中，我们直接比较了非典型抗精神病药物喹硫平和利培酮对患有痴呆且伴有感知障碍、思维内容、情绪或行为症状（痴呆的行为和心理症状 - BPSD）的老年患者的疗效和耐受性。
我们对72名门诊患者（55 - 85岁）进行了一项为期8周、评估者盲法的随机研究，这些患者患有BPSD（通过NPI基线评分评估），他们接受了灵活剂量的喹硫平（50 - 400毫克/天）或利培酮（0.5 - 2毫克/天）。主要疗效指标：神经精神科问卷（NPI）第1部分和第2部分；次要疗效指标：临床总体印象（CGI）、科恩 - 曼斯菲尔德激越量表（CMAI）、简易精神状态检查表（MMSE）、年龄校正浓度测试（AKT）。安全性评估包括锥体外系症状（EPS）和不良事件（AE）的发生率。
72名患者中有69名可进行疗效评估（72名进行了安全性评估），4名患者停药（3名因不良事件：喹硫平组2名，利培酮组1名；1名失访）。65名患者接受了喹硫平（n = 34；平均剂量77 ± 40毫克/天）或利培酮（n = 31；平均剂量0.9 ± 0.3毫克/天）。治疗组之间NPI评分无显著差异；在治疗组内，NPI评分从基线到第8周显著下降（与基线相比P≤0.05）。大多数患者（喹硫平组67.6%，利培酮组71.0%）有临床改善（CGI - 改善评分）；两种药物均降低了激越程度（CMAI评分）；且无认知障碍（MMSE和AKT评分）。在任何安全性指标方面，包括EPS，治疗组之间均无显著差异。4名患者发生严重不良事件（喹硫平组3名；利培酮组1名）；研究调查员认为均与治疗无关。无脑血管不良事件或死亡。
低剂量的喹硫平或利培酮在治疗老年患者的BPSD方面同样有效且一般耐受性良好（包括无认知障碍）。
