Tariot P N, Erb R, Podgorski C A, Cox C, Patel S, Jakimovich L, Irvine C
Department of Psychiatry, University of Rochester School of Medicine and Dentistry, N.Y, USA.
Am J Psychiatry. 1998 Jan;155(1):54-61. doi: 10.1176/ajp.155.1.54.
The efficacy, safety, and tolerability of carbamazepine in the treatment of agitation and aggression associated with dementia were assessed.
In 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.
The modal carbamazepine dose at 6 weeks was 300 mg/day, and a mean serum level of 5.3 micrograms/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.
This controlled study showed significant short-term efficacy of carbamazepine for agitation with generally good safety and tolerability.
评估卡马西平治疗与痴呆相关的激越和攻击行为的疗效、安全性及耐受性。
在一项为期6周的随机、多中心、平行组研究中，对51名患有激越和痴呆的养老院患者进行了个体化剂量的卡马西平与安慰剂的比较。除医生监测人员和药剂师外，所有参与者均对治疗不知情。主要结局指标为简明精神病评定量表（BPRS）和临床总体印象（CGI）总体改善评分。次要指标包括行为、攻击行为、认知、功能状态、工作人员时间、安全性和耐受性的测量。进行了意向性分析。
6周时卡马西平的典型剂量为300毫克/天，平均血清水平达到5.3微克/毫升。在计划的中期分析显示卡马西平比安慰剂更有益后，该研究提前终止。在6周内，卡马西平组的BPRS总分平均下降7.7分，安慰剂组下降0.9分，每周得分显示两组之间的差异逐渐增大。CGI评分显示，服用卡马西平的患者中有77%总体改善，服用安慰剂的患者中有21%总体改善。次要分析证实，积极变化是由于激越和攻击行为减少。该药物总体耐受性良好，认知或功能状态未发生变化。管理激越所需的工作人员时间，卡马西平组减少，而安慰剂组未减少。
这项对照研究表明，卡马西平对激越具有显著的短期疗效，且安全性和耐受性总体良好。
