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一项关于氯硝西泮国际非专利药品名称(Ro 5-4023,利必通(R))治疗局灶性癫痫和继发性全身性癫痫大发作的对照试验。

A controlled trial on clonazepam INN (Ro 5-4023, Rivotril (R)) in the treatment of focal epilepsy and secondary generalized grand mal epilepsy.

作者信息

Mikkelsen B, Birket-Smith E, Holm P, Lund M, Vestermark S, Olsen P Z

出版信息

Acta Neurol Scand Suppl. 1975;60:55-61. doi: 10.1111/j.1600-0404.1975.tb01390.x.

Abstract

In a controlled clinical investigation based on 14 patients with focal seizures and 3 patients with secondary generalized grand mal epilepsy, all with insufficient response to conventional anti-epileptic treatment, clonazepam (Rivotril(R)) combined with previous anti-epileotic drugs was compared with placebo combined with the same drugs. The trial was singleblind cross-over with sequential analyses. With a daily dose, depending upon age, of usually 3-6 mg, the antiepileptic effect of Clonazepam was significantly superior to placebo and was estimated as remarkably good. Side-effects in the form of somnolence, fatique, drowsiness and co-ordination disturbances occurred in most of the patients but subsided spontaneously or could be managed by slow increase or slight reduction in dosage.

摘要

在一项针对14例局灶性癫痫患者和3例继发性全身性癫痫大发作患者的对照临床研究中,所有患者对传统抗癫痫治疗反应不佳,将氯硝西泮(利必通)与先前的抗癫痫药物联合使用与安慰剂加相同药物进行比较。该试验为单盲交叉试验并采用序贯分析。根据年龄,氯硝西泮的日剂量通常为3至6毫克,其抗癫痫效果明显优于安慰剂,且评估效果非常好。大多数患者出现嗜睡、疲劳、困倦和协调障碍等副作用,但这些副作用会自行消退,或可通过缓慢增加或略微减少剂量来处理。

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