Efficacy and tolerability of carbamazepine for agitation and aggression in dementia.
Efficacy and tolerability of carbamazepine for agitation and aggression in dementia.
复制标题
卡马西平对痴呆症躁动和攻击行为的疗效和耐受性。
DOI：
10.1176/ajp.155.1.54
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发表时间：
1998
期刊：
影响因子：
--
通讯作者：
Irvine,C
中科院分区：
文献类型：
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作者：
Tariot,PN;Erb,R;Podgorski,CA;Cox,C;Patel,S;Jakimovich,L;Irvine,C
目的评价卡马西平治疗痴呆相关躁动和攻击的有效性、安全性和耐受性。方法在一项为期6周、随机、多地点、平行组研究中，对51名躁动和痴呆养老院患者进行个体化剂量卡马西平与安慰剂的比较。除了一名医生监督员和一名药剂师外，所有参与者都对治疗一无所知。主要结局指标为简短精神病学评定量表（BPRS）和临床总体印象（CGI）总体改善评定。次要测量包括行为、攻击、认知、功能状态、员工时间、安全性和耐受性。进行意向治疗分析。结果6周卡马西平剂量为300 mg/d，血清平均卡马西平浓度为5.3 μg/ml。在一项计划的中期分析显示卡马西平比安慰剂提供更多的益处后，该研究被终止。在6周内，卡马西平组和安慰剂组的平均总BPRS评分分别下降了7.7分和0.9分，两组的周评分逐渐出现差异。CGI评分显示，77%服用卡马西平的患者和21%服用安慰剂的患者整体改善。二次分析证实，积极的变化是由于躁动和攻击性的减少。该药耐受性良好，认知或功能状态未发生改变。卡马西平组对员工管理躁动所需时间的感知有所减少，而安慰剂组则没有。结论卡马西平治疗躁动短期疗效显著，安全性和耐受性良好。（美国精神病学杂志1998；155:54-61）
OBJECTIVEThe efficacy, safety, and tolerability of carbamazepine in the treatment of agitation and aggression associated with dementia were assessed.METHODIn a 6-week, randomized, multisite, parallel-group study of 51 nursing home patients with agitation and dementia, individualized doses of carbamazepine were compared with placebo. Except for a physician monitor and a pharmacist, all participants were blind to treatment. The primary outcome measures were the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression (CGI) global improvement rating. Secondary measures included measures of behavior, aggression, cognition, functional status, staff time, safety, and tolerability. Intent-to-treat analysis was performed.RESULTSThe modal carbamazepine dose at 6 weeks was 300 mg/day, and a mean serum level of 5.3 μg/ml was achieved. The study was terminated after a planned interim analysis showed that carbamazepine provided more benefit than did placebo. Over 6 weeks the mean total BPRS score decreased 7.7 points for the carbamazepine group and 0.9 for the placebo group, and the weekly scores showed a gradual divergence between the two groups. CGI ratings showed global improvement in 77% of the patients taking carbamazepine and 21% of those taking placebo. Secondary analyses confirmed that the positive changes were due to decreased agitation and aggression. The drug was generally well tolerated, and no change in cognition or functional status occurred. The perception of staff time needed to manage agitation showed a decrease for carbamazepine but not placebo.CONCLUSIONSThis controlled study showed significant short-term efficacy of carbamazepine for agitation with generally good safety and tolerability. (Am J Psychiatry 1998; 155:54–61)