Wilensky A J, Ojemann L M, Friel P N, Almes M J, Levy R H, Dodrill C B
Epilepsia. 1983 Aug;24(4):401-9. doi: 10.1111/j.1528-1157.1983.tb04908.x.
Monotherapy with the experimental antiepileptic drug cinromide was evaluated in 11 adult outpatients with uncontrolled partial epilepsy. They were treated with phenytoin for 2 months, cinromide for 4 months, and carbamazepine for 4 months. Four patients withdrew from the study during or shortly after crossover to cinromide due to increased seizure frequency or severity. Of the remainder, three preferred carbamazepine, two cinromide, and two phenytoin, based on both seizure control and degree of toxicity. Overall seizure control was not significantly different with any of the three agents, but during cinromide administration secondarily generalized seizure control was uniformly worst and there was also a tendency toward decreased performance on neuropsychological tests. CNS toxicity and gastrointestinal toxicity were prominent during the first month of cinromide treatment, but subsided with time or dose reduction. No abnormalities requiring drug withdrawal were found with laboratory testing. The results suggested, at best, a very limited clinical usefulness for cinromide, and it has been withdrawn from testing by its manufacturer.
在11名部分性癫痫控制不佳的成年门诊患者中评估了实验性抗癫痫药物辛罗胺的单一疗法。他们先接受苯妥英治疗2个月,再接受辛罗胺治疗4个月,最后接受卡马西平治疗4个月。4名患者在交叉使用辛罗胺期间或之后不久因癫痫发作频率或严重程度增加而退出研究。在其余患者中,基于癫痫控制和毒性程度,3人更喜欢卡马西平,2人更喜欢辛罗胺,2人更喜欢苯妥英。三种药物中的任何一种在总体癫痫控制方面均无显著差异,但在使用辛罗胺期间,继发性全身性癫痫控制始终最差,并且神经心理学测试表现也有下降趋势。在辛罗胺治疗的第一个月,中枢神经系统毒性和胃肠道毒性较为突出,但随着时间推移或剂量减少而消退。实验室检查未发现需要停药的异常情况。结果表明,辛罗胺的临床实用性非常有限,其制造商已停止对其进行测试。