Lancet Neurol:Cenobamate治疗不受控制的局灶性癫痫

2019-11-19 MedSci MedSci原创

研究发现,Cenobamate可减少局灶性(部分)发作癫痫发作频率。在最高剂量组中,治疗引起的不良事件最为常见。对于不受控制的局灶性癫痫患者,Cenobamate似乎是一种有效的治疗选择

超过三分之一的癫痫患者具有抗药性,因此需要新的、更有效的治疗手段。近日研究人员考察了Cenobamate (YKP3089)在不受控制的局灶性(部分)发作性癫痫患者中的安全性、有效性和耐受性。

研究人员在16个国家的107个癫痫和神经内科中心进行了多中心、双盲、随机化、安慰剂对照、剂量反应研究。尽管使用1-3抗癫痫药物治疗,但仍有局灶性癫痫发作的成年患者(年龄18-70岁)参与研究,在8周的基线评估后,每日口服一次cenobamate 100 mg、200 mg或400 mg剂量组或安慰剂。研究包括6周的滴定阶段和12周的维持期。主要疗效结果为28天局灶性发作,包括局灶性运动,局灶性意识受损或双侧强直阵挛性癫痫发作与基线相比的百分比变化。

437名患者被随机分配到安慰剂(n=108)或cenobamate 100 mg(n=108)、200 mg(n=110)或400 mg(n=111)治疗组,有434人被包括在改良的治疗意向人群中(安慰剂组106人[98%],100mg组108人[100%],200mg组109人[99%],400mg组111人[100%]),397人被纳入改良意向治疗维持期(安慰剂组102人[94%],100 mg组102人[94%],200 mg组98人[89%],400 mg组95人[86%])。对于安慰剂组,癫痫发作频率的中位百分比变化为-24.0%,100mg组的癫痫发作频率中位数百分比变化为-35.5% ,200 mg组为-55.0%,400 mg组为-55.0%。安慰剂组在维持期的应答率为25%,100mg组在维持期的应答率为40%,200mg组56%,400mg组为64%。安慰剂组108例患者中有76例(70%),100 mg组108例中有70例(65%),200 mg组110例中有84例(76%),400 mg组111例中有100例(90%)出现治疗后不良事件。安慰剂组5人(5%),100mg组11人(10%)、200mg组15人(14%)和400mg组22人(20%),

因不良事件导致停止治疗。200mg组出现严重的药物反应--伴有嗜酸性粒细胞增多和系统症状。无死亡报告。

研究发现,Cenobamate可减少局灶性(部分)发作癫痫发作频率。在最高剂量组中,治疗引起的不良事件最为常见。对于不受控制的局灶性癫痫患者,Cenobamate似乎是一种有效的治疗选择。

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    2020-04-17 zsyan
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    2020-05-23 yinhl1978
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    2020-08-22 howi
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