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文章摘要的研究相比疗效和耐受性的氨己烯酸3克/天附加与安慰剂治疗局灶性癫痫患者的复杂部分发作与建立antiepilepsy药物治疗难以控制。我们招收了203名病人;182(90安慰剂;在双盲条件下92氨己烯酸)接受药物治疗。我们每日剂量增加到2.5克/天在四周滴定段和维护它在3 g /天为期12周的维护。通过分析,我们发现了一个显著降低癫痫发作频率(复杂的癫痫发作和部分癫痫发作其次广义)在研究结束时比那些接受安慰剂的患者接受氨己烯酸。平均每月的频率降低了氨己烯酸组(三个每28天发作基线,8.3;研究,5.3)和0.8每28天发作在安慰剂组(基线,8.3;研究,7.5)(p = 0.0002)。治疗成功(从基线下降50%的月平均发作频率)是获得40氨己烯酸的患者(43%)比17的治疗与安慰剂组(19%)(p < 0.001)。 Vigabatrin significantly increased the mean number of seizure-free days per 28 days (2.2 days) compared with placebo (0.5 days) (p = 0.0024). Mean trough serum vigabatrin concentration during therapy was 8.6 +/- 7.7 micro g/ml. The oral clearance of vigabatrin was determined to be 7.8 L/hr, and the elimination half-life was 8.4 hours. No clinically important changes in MRI, evoked potential, or other laboratory tests were noted during vigabatrin treatment. The results of this study indicate that 3 g/day vigabatrin is more effective than placebo as add-on therapy. Vigabatrin was well tolerated, compliance was high with twice-daily administration, and therapy did not result in clinically relevant drug interactions.
首页神经学1996;46:54 - 61
- 版权1996年Advanstar通信公司。
