Patsalos P N, Russell-Jones D, Finnerty G, Sander J W, Shorvon S D
INSEG (Institute of Neurology, National Hospital for Nervous Disease), Queen Square, London, U.K.
Epilepsy Res. 1990 Apr;5(3):235-9. doi: 10.1016/0920-1211(90)90044-v.
Carbamazepine (CBZ) is a widely used antiepileptic drug (AED). Recently, a chewable tablet (Tegretol chewtabs) has been formulated. This open substitution study was designed to compare the two formulations with respect to efficacy and tolerability in patients with intractable epilepsy. Thirty patients (24 males, 6 females, mean age 46 years, range 28-83) were studied. Duration of epilepsy was 21-68 years (median 34 years). Four patients were taking CBZ monotherapy, 17, 6 and 3 patients were respectively taking CBZ plus 1, 2 and 3 additional AEDs. Upon entry to study, patients were switched to an equivalent dose of chewtabs and subsequently evaluated at 2, 4, 8 and 12 weeks. Two patients did not complete the study. On entry, the mean 14 day seizure rate was 2.5. On chewtabs mean 14 day rates were 2.4, 2.2, 2.4 and 2.7 after 2, 4, 8 and 12 weeks of treatment respectively. On entry the mean steady state trough serum CBZ concentration was 35 mumols/l compared to 32, 31, 32 and 34 mumols/l after 2, 4, 8 and 12 weeks respectively. Nineteen patients were classified showing good or excellent tolerability, 7 satisfactory and 2 fair. In conclusion, chewtabs were essentially equivalent to the conventional formulation in efficacy and tolerability. After 12 weeks treatment, 19 patients preferred the chewable formulation.
卡马西平(CBZ)是一种广泛使用的抗癫痫药物(AED)。最近,已研制出一种咀嚼片(得理多咀嚼片)。这项开放性替代研究旨在比较这两种制剂对难治性癫痫患者的疗效和耐受性。研究了30例患者(24例男性,6例女性,平均年龄46岁,范围28 - 83岁)。癫痫病程为21 - 68年(中位数34年)。4例患者接受卡马西平单一疗法,17例、6例和3例患者分别同时服用卡马西平加1种、2种和3种其他抗癫痫药物。进入研究时,患者换用等效剂量的咀嚼片,随后在2周、4周、8周和12周进行评估。2例患者未完成研究。入组时,平均14天癫痫发作率为2.5次。服用咀嚼片后,治疗2周、4周、8周和12周后的平均14天发作率分别为2.4次、2.2次、2.4次和2.7次。入组时平均稳态谷浓度血清卡马西平浓度为35μmol/L,相比之下,治疗2周、4周、8周和12周后分别为32μmol/L、31μmol/L、32μmol/L和34μmol/L。19例患者被分类为耐受性良好或极佳,7例满意,2例一般。总之,咀嚼片在疗效和耐受性方面基本等同于传统制剂。治疗12周后,19例患者更喜欢咀嚼片剂型。