Tariot P N, Frederiksen K, Erb R, Leibovici A, Podgorski C A, Asnis J, Cox C
Department of Psychiatry, University of Rochester Medical Center, New York, USA.
J Am Geriatr Soc. 1995 Sep;43(9):1026-9. doi: 10.1111/j.1532-5415.1995.tb05568.x.
To assess the effects of carbamazepine and placebo on measures of toxicity in frail nursing home patients.
A nonrandomized, double-blind, placebo-controlled crossover study.
Two nursing homes in Rochester, New York.
Twenty-five subjects (mean age 84.5 years) with dementia.
Carbamazepine and placebo during two 5-week periods separated by a 2-week washout. The modal dose for each patient was 300 mg/day.
Adverse experiences, comorbid events, and physical signs and symptoms were assessed continuously, and laboratory data were examined at the beginning and end of each treatment period.
One subject died with a pneumonia (and elevated white blood cell count), and one subject developed probable carbamazepine-induced tics. There was a minimal drop in hematocrit and a slight elevation of liver enzymes, none of which was clinically significant. There was otherwise no excess of adversity or comorbid events on carbamazepine versus placebo, and there was no change in electrolytes or other laboratory measures.
The findings indicate that carbamazepine in this dose range was well tolerated for the 5-week treatment period in this frail sample. These data supplement the literature regarding carbamazepine toxicity, which is devoid of controlled studies in older subjects.
评估卡马西平与安慰剂对体弱疗养院患者毒性指标的影响。
一项非随机、双盲、安慰剂对照的交叉研究。
纽约罗切斯特的两家疗养院。
25名患有痴呆症的受试者（平均年龄84.5岁）。
在两个为期5周的时间段内分别使用卡马西平和安慰剂，中间间隔2周的洗脱期。每位患者的标准剂量为300毫克/天。
持续评估不良经历、合并症事件以及身体体征和症状，并在每个治疗期开始和结束时检查实验室数据。
1名受试者死于肺炎（白细胞计数升高），1名受试者出现可能由卡马西平引起的抽搐。血细胞比容有轻微下降，肝酶有轻微升高，但均无临床意义。与安慰剂相比，卡马西平在其他方面没有过多的不良反应或合并症事件，电解质或其他实验室指标也没有变化。
研究结果表明，在这个体弱的样本中，该剂量范围的卡马西平在5周治疗期内耐受性良好。这些数据补充了关于卡马西平毒性的文献，此前该文献缺乏针对老年受试者的对照研究。
