摘要
目的评价左乙拉西坦(LEV)添加用药治疗难治性部分性癫癎发作的临床疗效及安全性。方法随机、双盲、安慰剂对照、多中心平行设计添加治疗,确诊为有癫癎部分性发作的202例癫癎患者,平均年龄(32.8±12.7)岁,随机分配入 LEV 治疗组(n=102)与安慰剂组(n=100)。在回顾8周基线期的癫癎发作频率后,进入逐量加药期。初始用药剂量为0.5 g,每日2次,2周后增加至1.0g,每日2次服用,4周后加量至1.5 g,每日2次,随后维持该剂量治疗12周,最后逐渐减量并转入 LEV 开放治疗期。主要评价指标为16周治疗期内每周癫癎发作频率的比较、得出药物治疗发作频率减少50%有效率、安全性和药物不良反应。结果在16周治疗期内,LEV 组每周癫癎发作频率明显减少,较安慰剂组减少26.8%;每周发作频率较基线期下降数在 LEV 组与安慰剂组的组间差异为42.2%;部分性发作频率减少50%有效率为55.9%,与安慰剂组比的 OR 值为3.6;有11例治疗后完全无发作,两组相比均有显著统计学意义(P<0.001)。LEV 组的主要不良事件为嗜睡、头晕、无力及血小板减少,但与安慰剂组比差异无统计学意义。结论 LEV 添加用药治疗成人难治性部分性癫癎发作,可以显著减少癫癎发作频率,安全性良好。
Objective To evaluate the efficacy and tolerability of levetiracetam （LEV） as add-on therapy in patients with refractory partial seizures. Methods In this Chinese muhicenter, double-blind, randomized, placebo-controlled trial, LEV was compared with placebo add-on therapy in 202 patients （intent-to treat （ITT） population） over 16 years old （mean, 32. 8 ± 12. 7 years） with uncontrolled partialonset seizures. All patients entered an g-week baseline period followed by a 4-week titration interval and a 12-week maintenance period. Patients initially received LEV 0：5 g twice daily, 2 weeks later change to 1.0 g twice daily, and after another 2 weeks change to 1.5 g twice daily. The main outcome was measured by in the decrease of seizure frequency per week, the 50% responder rate, global evaluation scale （GES） , and adverse events. Results During the 16 weeks of the trial, LEV significantly decreased the seizure frequency by 26. 8% compared with placebo, the median reduced percentage in seizure frequency from baseline was 55.95% for LEV, and 13.73% for placebo. 55.9% of the patients experienced a 50% reduction in the seizure frequency in LEV group, compared with 26. 0% of patients in the placebo group; moreover, and 11 （10. 8% ） patients in LEV group were seizure free. The most common adverse events in LEV group were somnolence, dizziness, asthenia and thrombocytopenia; they were predominantly mild in nature. Conclusion These results provide further evidence regarding the efficacy and safety of LEV as adjunctive treatment for partial-onset seizures.
出处
《中华神经科杂志》
CAS
CSCD
北大核心
2007年第3期149-153,共5页
Chinese Journal of Neurology
关键词
癫痫
部分性
抗惊厥药
吡拉西坦
随机对照试验
Epilepsies, partial
Anticonvulsants
Piracetam
Randomized controlled trials
