Quetiapine and rivastigmine and cognitive decline in Alzheimer's disease: randomised double blind placebo controlled trial
Quetiapine and rivastigmine and cognitive decline in Alzheimer's disease: randomised double blind placebo controlled trial
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DOI：
10.1136/bmj.38369.459988.8f
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发表时间：
2005-04-16
影响因子：
105.7
通讯作者：
Jacoby, R
中科院分区：
文献类型：
--
作者：
Ballard, C;Margallo-Lana, M;Jacoby, R
目的确定奎替鲁和卡巴拉汀对机构护理中痴呆患者激越的各自疗效，并评估这些治疗对认知能力变化的影响。设计（临床医生，患者，结果评估者）安慰剂对照试验。设置在英格兰北部的护理设施。参与者93例阿尔茨海默病，痴呆，干预非典型抗精神病药（奎替鲁）、胆碱酯酶抑制剂（卡巴拉汀）或安慰剂（双模拟）。主要结果测量基线、6周和26周时的激越（Cohen-Mansfield激越量表）和认知（严重损害成套测验）。结果31例患者被随机分配到每组，80例（86%）开始治疗（25例卡巴拉汀，26例奎替利，29例安慰剂），其中71例（89%）耐受最大方案剂量（22例卡巴拉汀，23例奎替利，26例安慰剂）。与安慰剂相比，无论是在第6周还是第26周，两组在激越量表的改善方面都没有显着差异。56例患者在基线时重度功能障碍组合评分> 10分，其中46例（82%）患者在6周随访时纳入分析（利斯的明14例，奎替鲁14例，安慰剂18例）。对于奎替鲁肽，重度功能障碍成套测验评分较基线的变化估计为在第6周（P = 0.009）时比安慰剂组平均低-14.6分（95%置信区间-25.3至-4.0），在第26周时比安慰剂组平均低-15.4分（-27.0至-3.8）（P = 0.01）。卡巴拉汀组的相应变化在6周时降低了-3.5分（-13.1至6.2）（P = 0.5），在26周时降低了-7.5分（-21.0至6.0）（P = 0.3）。结论奎替鲁肽和卡巴拉汀均不能有效治疗机构护理中痴呆患者的激越。与安慰剂相比，奎替鲁肽与显著更大的认知能力下降相关。
Objectives To determine the respective efficacy of quetiapine and rivastigmine for agitation in people with dementia in institutional care and to evaluate these treatments with respect to change in cognitive performance.Design Randomised double blind (clinician, patient, outcomes assessor) placebo controlled trial.Setting Care facilities in the north cast of England.Participants 93 patients with Alzheimer's disease, dementia, and clinically significant agitation.Intervention Atypical antipsychotic (quetiapine), cholinesterase inhibitor (rivastigmine), or placebo (double dummy).Main outcome measures Agitation (Cohen-Mansfield agitation inventory) and cognition (severe impairment battery) at baseline and at six weeks and 26 weeks. ne primary outcome was agitation inventory at six weeks.Results 31 patients were randomised to each group, and 80 (86%) started treatment (25 rivastigmine, 26 quetiapine, 29 placebo), of whom 71 (89%) tolerated the maximum protocol dose (22 rivastigmine, 23 quetiapine, 26 placebo). Compared with placebo, neither group showed significant differences in improvement on the agitation inventory either at six weeks or 26 weeks. Fifty six patients scored > 10 on the severe impairment battery at baseline, 46 (82%) of whom were included in the analysis at six week follow up (14 rivastigmine, 14 quetiapine, 18 placebo). For quetiapine the change in severe impairment battery score from baseline was estimated as an average of -14.6 points (95% confidence interval -25.3 to -4.0) lower (that is, worse) than m the placebo group at six weeks (P = 0.009) and -15.4 points (-27.0 to -3.8) lower at 26 weeks (P = 0.01). The corresponding changes with rivastigmine were -3.5 points (-13.1 to 6.2) lower at six weeks (P = 0.5) and -7.5 points (-21.0 to 6.0) lower at 26 weeks (P = 0.3).Conclusions Neither quetiapine nor rivastigmine is effective in the treatment of agitation in people with dementia in institutional care. Compared with placebo, quetiapine is associated with significantly greater cognitive decline.