Blackburn S C, Oliart A D, García Rodríguez L A, Pérez Gutthann S
Department of Clinical Drug Safety and Pharmacoepidemiology, Ciba Pharmaceuticals, Horsham, United Kingdom.
Pharmacotherapy. 1998 Nov-Dec;18(6):1277-83.
We conducted a cohort study to investigate the frequency of serious blood dyscrasias in patients age 10-74 years, taking antiepileptic drugs between January 1, 1990, and October 31, 1994. Main outcome measures were validated diagnoses of neutropenia, agranulocytosis, hemolytic anemia, thrombocytopenia, bicytopenia, pancytopenia, or aplastic anemia. A total of 29,357 recipients of antiepileptic therapy received 684,706 prescriptions. Among them there were 21 cases of serious blood dyscrasia of which only 18 could be considered to have a temporal relationship to drug use. Seventeen cases occurred in current users of carbamazepine, phenobarbital, phenytoin or valproate, and 7 in patients taking two or more drugs. Twenty of the 21 patients recovered. The overall rate of blood dyscrasias was 3-4/100,000 prescriptions. The rate in those age less than 60 years was 2.0 (range 0.9-3.6)/100,000 prescriptions compared with 4.0 (range 1.6-8.2) for those age 60 or older. The overall rate of neutropenia was 1.2 (0.5-2.3)/100,000 prescriptions, compared with 0.9 (0.3-1.9) for thrombocytopenia and 0.4 (0.1-1.3) for hemolytic anemia. Rates did not differ among the four drugs. Serious blood dyscrasias are rare in patients taking antiepileptic agents.
我们进行了一项队列研究，以调查1990年1月1日至1994年10月31日期间年龄在10至74岁、服用抗癫痫药物的患者中严重血液系统疾病的发生频率。主要观察指标为中性粒细胞减少症、粒细胞缺乏症、溶血性贫血、血小板减少症、双血细胞减少症、全血细胞减少症或再生障碍性贫血的确诊病例。共有29357名接受抗癫痫治疗的患者开具了684706张处方。其中有21例严重血液系统疾病，其中只有18例可被认为与药物使用存在时间关联。17例发生在当前使用卡马西平、苯巴比妥、苯妥英或丙戊酸盐的患者中，7例发生在服用两种或更多药物的患者中。21例患者中有20例康复。血液系统疾病的总体发生率为每100000张处方3 - 4例。年龄小于60岁者的发生率为每100000张处方2.0（范围0.9 - 3.6）例，而60岁及以上者为每100000张处方4.0（范围1.6 - 8.2）例。中性粒细胞减少症的总体发生率为每100000张处方1.2（0.5 - 2.3）例，血小板减少症为0.9（0.3 - 1.9）例，溶血性贫血为0.4（0.1 - 1.3）例。四种药物之间的发生率没有差异。服用抗癫痫药物的患者中严重血液系统疾病很少见。
