Houtkooper M A, van Oorschot C A, Rentmeester T W, Höppener P J, Onkelinx C
Epilepsia. 1986 May-Jun;27(3):255-62. doi: 10.1111/j.1528-1157.1986.tb03537.x.
Milacemide, 2-N-pentylaminoacetamide, a glycine prodrug, which readily crosses the blood-brain barrier, has been tested for antiepileptic efficacy and tolerability in 30 patients compared in a double-blind design with 30 patients treated with placebo. All patients continued to receive, without alteration, their previous partly effective medication. All patients presented an average of at least 10 seizures a month during the 6 months preceding the trial with no more than 50% fluctuation. The ratio of seizure frequency in the trial period over the seizure frequency in the baseline period (RSF) was calculated. In the milacemide group, 9 of 29 patients had an RSF less than 0.7 as opposed to 2 of 29 in the placebo group. Although no firm proof of therapeutic efficacy, this and the dramatic improvement of a patient with myoclonus epilepsy indicates that further studies are warranted. This opinion is strengthened if one considers the subgroup of patients aged less than or equal to 25 years in which a statistically significant reduction in seizure frequency was observed with milacemide treatment. The drug was well tolerated.
米拉醋胺,即2 - N - 戊基氨基乙酰胺,一种甘氨酸前体药物,能轻易穿过血脑屏障。在一项双盲设计中,对30例患者进行了米拉醋胺抗癫痫疗效和耐受性测试,并与30例接受安慰剂治疗的患者进行比较。所有患者继续原有的部分有效药物治疗,剂量不变。在试验前的6个月里,所有患者平均每月至少发作10次,发作次数波动不超过50%。计算了试验期癫痫发作频率与基线期癫痫发作频率之比(RSF)。米拉醋胺组29例患者中有9例RSF小于0.7,而安慰剂组29例患者中只有2例。虽然没有确凿的治疗效果证据,但这一点以及1例肌阵挛性癫痫患者的显著改善表明有必要进行进一步研究。如果考虑年龄小于或等于25岁的患者亚组,米拉醋胺治疗使癫痫发作频率有统计学意义的降低,这一观点就更有说服力了。该药物耐受性良好。