Randomized trial of lacosamide versus fosphenytoin for nonconvulsive seizures.
Randomized trial of lacosamide versus fosphenytoin for nonconvulsive seizures.
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DOI：
10.1002/ana.25249
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发表时间：
2018-06
影响因子：
11.2
通讯作者：
Critical Care EEG Monitoring Research Consortium
中科院分区：
文献类型：
--
作者：
Husain AM;Lee JW;Kolls BJ;Hirsch LJ;Halford JJ;Gupta PK;Minazad Y;Jones JM;LaRoche SM;Herman ST;Swisher CB;Sinha SR;Palade A;Dombrowski KE;Gallentine WB;Hahn CD;Gerard EE;Bhapkar M;Lokhnygina Y;Westover MB;Critical Care EEG Monitoring Research Consortium
危重病人非惊厥性发作的最佳治疗方法尚不确定。我们评估了抗癫痫药物拉科沙胺（LCM）和磷酸苯妥英（fPHT）在该人群中的比较有效性。TRENdS（复发性非惊厥性电图发作的治疗）研究是一项通过连续脑电图（cEEG）诊断为非惊厥性发作（NCSs）的患者的非效性、前瞻性、多中心、随机治疗试验。治疗随机分为静脉注射（IV） LCM 400mg或静脉注射fPHT 20mg苯妥英当量/kg。主要终点是由一名盲法EEG审查员确定的24小时内没有电图癫痫发作。比较各组实现NCS控制的频率，确定90%置信区间（CI）。如果相对危险度CI的下界为bb0 0.8，则LCM对fPHT的非劣效性得到结论。2012年8月21日至2013年12月20日，共纳入74名受试者（37名LCM， 37名fPHT）。平均年龄63.6岁；38人是女性。LCM组30例中有19例（63.3%）癫痫发作得到控制，fPHT组32例中有16例（50%）癫痫发作得到控制。LCM不逊于fPHT (p = 0.02)，风险比为1.27 （90% CI = 0.88-1.83）。治疗紧急不良事件（teae）在两组中相似，35例LCM患者中有9例（25.7%）发生，37例fPHT患者中有9例（24.3%）发生（p = 1.0）。LCM在控制NCS方面不逊于fPHT， teae具有可比性。在脑电图检测到的ncs治疗中，LCM可以被认为是fPHT的替代方案。
The optimal treatment of nonconvulsive seizures in critically ill patients is uncertain. We evaluated the comparative effectiveness of the antiseizure drugs lacosamide (LCM) and fosphenytoin (fPHT) in this population. The TRENdS (Treatment of Recurrent Electrographic Nonconvulsive Seizures) study was a noninferiority, prospective, multicenter, randomized treatment trial of patients diagnosed with nonconvulsive seizures (NCSs) by continuous electroen-cephalography (cEEG). Treatment was randomized to intravenous (IV) LCM 400mg or IV fPHT 20mg phenytoin equivalents/kg. The primary endpoint was absence of electrographic seizures for 24 hours as determined by 1 blinded EEG reviewer. The frequency with which NCS control was achieved in each arm was compared, and the 90% confidence interval (CI) was determined. Noninferiority of LCM to fPHT was to be concluded if the lower bound of the CI for relative risk was >0.8. Seventy-four subjects were enrolled (37 LCM, 37 fPHT) between August 21, 2012 and December 20, 2013. The mean age was 63.6 years; 38 were women. Seizures were controlled in 19 of 30 (63.3%) subjects in the LCM arm and 16 of 32 (50%) subjects in the fPHT arm. LCM was noninferior to fPHT (p = 0.02), with a risk ratio of 1.27 (90% CI = 0.88–1.83). Treatment emergent adverse events (TEAEs) were similar in both arms, occurring in 9 of 35 (25.7%) LCM and 9 of 37 (24.3%) fPHT subjects (p = 1.0). LCM was noninferior to fPHT in controlling NCS, and TEAEs were comparable. LCM can be considered an alternative to fPHT in the treatment of NCSs detected on cEEG.
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