Askmark H, Wiholm B E
Department of Neurology, Uppsala University Hospital, Sweden.
Acta Neurol Scand. 1990 Feb;81(2):131-40. doi: 10.1111/j.1600-0404.1990.tb00949.x.
A survey was made of 505 reports on 713 adverse reactions to carbamazepine submitted to the Swedish Adverse Drug Reactions Advisory Committee from 1965-1987. For the period after 1972, the relation between the reports and sales statistics could be investigated. The total incidence of reported adverse reactions to carbamazepine was 4.5 per million defined daily doses (DDD), corresponding to 2.7 per million prescribed daily doses (PDD). Most often reported were skin reactions (48%), but reports on haematological (12%) and hepatic disorders (10%) were also frequent. Virtually all hepatic disorders and severe skin reactions, as well as the majority (60%) of the haematological reactions, occurred within the first 2 months of treatment. In view of the very low incidence of reported serious blood dyscrasias, such as pancytopenia (0.04/million PDD) and agranulocytosis (0.06/million PDD), continuous haematological monitoring seems to be of little value. The elderly appear to be at increased risk of developing blood dyscrasias and liver reactions, and alcohol abusers seem to represent a high-risk group for developing serious skin reactions.
对1965年至1987年期间提交给瑞典药物不良反应咨询委员会的505份关于713例卡马西平不良反应的报告进行了调查。对于1972年以后的时期，可以研究报告与销售统计数据之间的关系。报告的卡马西平不良反应总发生率为每百万限定日剂量（DDD）4.5例，相当于每百万规定日剂量（PDD）2.7例。最常报告的是皮肤反应（48%），但血液学（12%）和肝脏疾病（10%）的报告也很常见。几乎所有的肝脏疾病和严重皮肤反应，以及大多数（60%）血液学反应都发生在治疗的前2个月内。鉴于报告的严重血液系统疾病（如全血细胞减少症，每百万PDD为0.04例；粒细胞缺乏症，每百万PDD为0.06例）的发生率极低，持续的血液学监测似乎价值不大。老年人发生血液系统疾病和肝脏反应的风险似乎增加，而酗酒者似乎是发生严重皮肤反应的高危人群。
