左乙拉西坦添加或单药治疗睡眠期癫痫电持续状态疗效观察

目的 探讨左乙拉西坦对于睡眠期癫痫性电持续状态(ESES)的患儿临床治疗疗效。方法 对于50例癫痫合并ESES患儿给予左乙拉西坦添加治疗(13例)或单药治疗(37例)。在治疗前后观察临床发作、长程视频脑电图以及智商情况,分析左乙拉西坦对于消除ESES现象,控制临床发作方面的作用,及对患儿认知的影响。结果 2例病例失访,共48例患儿完成了至少1年的随访,29例患儿发作完全控制,8例患儿发作减少50%以上,11例患儿无效,临床发作有效率为77.1%;棘波指数(SWI)减少超过75%者有14例(29.2%),减少超过50%者11例(22.9%),总有效率为52.1%。治疗前后自身对照后发现在操作能、言语能和总智商方面差异均无统计学意义(P均>0.05)。左乙拉西坦对于变异型良性儿童癫痫伴中央颞区棘波(ABECT)的脑电图有效率为69.6%,显著高于其他综合征。结论 左乙拉西坦治疗ESES对临床发作及睡眠期的SWI均有改善作用,并且安全有效,长期口服左乙拉西坦没有对患儿造成认知损害。左乙拉西坦对于ABECT疗效优于其他综合征。     

卡马西平与左乙拉西坦治疗成人癫痫的效果及对认知功能和骨密度的影响分析

目的探究卡马西平与左乙拉西坦治疗成人癫痫的效果及对认知功能、骨密度的影响。方法92例成人癫痫患者作为研究对象,随机分为左乙拉西坦组与卡马西平组,各46例。左乙拉西坦组采用左乙拉西坦治疗,卡马西平组采用卡马西平治疗。比较两组患者治疗前及治疗6个月后认知功能[语言智商(VIQ)、操作智商(PIQ)、总智商(FIQ)]评分、骨密度(腰椎、股骨大转子、股骨颈)变化情况。结果治疗6个月后,两组患者VIQ、PIQ、FIQ评分均较治疗前显著提升,且左乙拉西坦组患者VIQ评分(101.2±3.1)分、PIQ评分(108.1±2.3)分、FIQ评分(105.2±1.8)分均明显高于卡马西平组的(95.1±2.8)、(94.1±2.0)、(93.5±1.6)分,差异有统计学意义(P<0.05)。治疗6个月后,卡马西平组患者腰椎、股骨大转子、股骨颈骨密度均较治疗前显著下降,且明显低于卡马西平组,差异有统计学意义(P<0.05);左乙拉西坦组治疗6个月后腰椎、股骨大转子、股骨颈骨密度与治疗前比较差异无统计学意义(P>0.05)。结论左乙拉西坦与卡马西平治疗成人癫痫,左乙拉西坦更能明显提升患者认知功能,且对患者骨密度无影响。     

左乙拉西坦与苯妥英作为二线用药治疗儿童惊厥性癫痫持续状态的有效性及安全性的Meta分析

目的 系统评价左乙拉西坦（LEV）和苯妥英（PHT）作为二线用药治疗儿童惊厥性癫痫持续状态（CSE）的有效性及安全性。方法 检索中英文电子数据库，纳入对比LEV和PHT作为二线用药治疗儿童CSE的有效性及安全性的随机对照试验。使用RevMan 5.3软件进行数据分析。结果 纳入7个研究，共1 434名患儿。Meta分析结果显示，LEV组CSE的控制率高于PHT组（RR=1.12，95% CI：1.00~1.24，P=0.05）；24 h内癫痫复发率（RR=0.82，95% CI：0.22~3.11，P=0.77）和需要进一步抗癫痫药物治疗率（RR=0.97，95% CI：0.64~1.45，P=0.87）两组比较差异无统计学意义。两组不良事件发生率差异无统计学意义（RR=0.77，95% CI：0.55~1.09，P=0.15）。结论 LEV治疗儿童CSE的有效性优于PHT，且不增加不良反应的发生率。     

Effect of levetiracetam on behavioral problems in pervasive developmental disorder children with epilepsy

AimsWe investigated the relationship between behavioral problems, location of electroencephalogram (EEG) paroxysmal abnormalities (PA), and treatment with levetiracetam in children with pervasive developmental disorder (PDD) and epilepsy.MethodsTwelve PDD children with epilepsy were included in the study. All patients had EEG PA (frontal spikes, 8; rolandic, 3; generalized, 1). After a 3-month baseline period, patients were given levetiracetam with an initial dose of 10 mg/kg/day for the first week, followed by increments of 5 mg/kg/day every week. Levetiracetam dosage was then adjusted up to a maximum of 60 mg/kg/day. EEG recordings were performed every 3 months, focusing on PA frequency. We counted the frequency of seizures and EEG PA, and scored instances of panic/aggressive behaviors.ResultsEight (66.7%) of the 12 patients were considered to be responders to clinical seizures and EEG findings (≥50% reduction in both seizures and PA frequency). Six (75%) of these eight patients were considered to be responders for behavioral problems (≥50% reduction in panic/aggressive behavior). These six patients had frontal EEG paroxysms, whereas the remaining two patients without behavioral responses had rolandic EEG paroxysms. Patients with frontal PA showed a significantly higher correlation between EEG/clinical seizures and behavioral improvements (p < 0.05).ConclusionThe present data indicated the usefulness of LEV in reducing behavioral problems related to the reduction of seizures and frontal spikes in PDD for some but not all of the patients. Thus, levetiracetam represents an important addition to treatment for PDD children with epilepsy presenting with frontal EEG paroxysms.     

Levetiracetam for the treatment of hot flashes: a phase II study

Goals of work The objectives of this pilot trial were to assess the potential efficacy and safety of levetiracetam for the treatment of hot flashes, a major cause of morbidity among breast cancer survivors. Patients and methods Women, aged 18 years or more, with a history of breast cancer or those who wished to avoid estrogen because of a perceived increased risk of breast cancer, who were experiencing bothersome hot flashes (more than or equal to 14 times per week, for more than or equal to 1 month before study entry), were included. During the baseline week, general demographic characteristics, hot flash information, and quality of life data were obtained. At the beginning of week 2, patients were started on levetiracetam for a total of 4 weeks. Information about hot flashes, quality of life, and toxicity were collected during these 4 weeks and compared with the baseline week. Main results After treatment with levetiracetam for 4 weeks (N = 19), mean hot flash scores (frequency times mean severity) were reduced by 57%, and mean hot flash frequencies were reduced by 53%, compared to the baseline week; both these reductions were greater than what would be expected with a placebo (20–25% reduction). There were significant improvements in abnormal sweating (p = 0.004), hot flash distress (p = 0.0002), and satisfaction of hot flash control (p = 0.0001), when comparing data from the fourth week of treatment to the baseline week. Twenty-nine percent of the subjects did not complete the study because of treatment-related adverse events, with the most frequently reported side effects being somnolence, fatigue, and dizziness, usually with mild to moderate intensity. Conclusion The results of this pilot trial suggest that levetiracetam might be an effective therapy for the treatment of hot flashes. Further data are needed to test this hypothesis, evaluating the efficacy and toxicity of this agent. Financial Disclosure: None     

An open-label pilot study on the efficacy and tolerability of levetiracetam in the prophylaxis of migraine

Abstract A preliminary, open label study was conducted on 20 patients with migraine without aura and with high headache frequency to assess the efficacy and tolerability of the new antiepileptic drug levetiracetam. Patients were treated with levetiracetam for three months. The drug was started at a dose of 500 mg and slowly increased within 10 days to the target dose of 2000 mg/day. After 3 months of treatment, 11 (57.9%) of 19 patients who completed the study had a reduction of at least 50% in headache frequency. The intensity of migraine attacks was significantly reduced as was the use of symptomatic drugs. A 3-month carry-over effect was found in about two-thirds of the 11 patients reporting a positive treatment response. Levetiracetam was well tolerated and no patient discontinued the drug due to side effects. This preliminary study supports the potential role of levetiracetam as a new preventive treatment for migraine without aura. The promising results obtained should be confirmed by further research with a double-blind controlled design.     

左乙拉西坦添加治疗学龄期难治性癫痫患儿认知功能与生活质量的影响

目的观察并探讨左乙拉西坦(levetiracetam,LEV)添加治疗对学龄期难治性癫痫(refractory epilepsy,RE)患儿认知功能与生活质量的影响。方法入选2013年6月至2015年12月收治的55例RE儿童为研究对象,所有患儿在继续原有治疗方案基础上行LEV添加治疗16周,起始剂量8~10 mg/(kg·d),逐步加量至50 mg/(kg·d),达标后维持剂量30 mg/(kg·d),期间记录药物不良反应,治疗结束后判定临床疗效,采用韦氏儿童智力量表评价患儿认知功能,采用儿童癫痫生活质量量表评价生活质量改变。结果患儿治疗后癫痫平均发作次数(3.8±1.3 vs.6.6±2.3)次/月较入组前明显下降(P0.05)。治疗后临床控制率、显效率、有效率、无效率分别为9.1%、36.4%、43.6%、10.9%,总体有效率为89.1%。患儿治疗后WISC-CR智力评价中算术(10.9±2.6 vs.9.2±2.1)、填图评分(15.1±3.9 vs.13.8±3.3)较治疗前显著提高(P0.05)。患儿治疗后QOLCE评价中生活质量总分(65.7±5.7vs.62.8±4.9)及认知功能(60.0±5.7 vs.57.4±6.2)、社会功能(65.0±6.3 vs.62.5±5.5)评分显著高于治疗前(P0.05)。服药期间,患儿头晕、乏力、嗜睡、易激惹、欣快感、一过性转氨酶升高发生率分别为12.7%、9.1%、20.0%、5.5%、3.6%、3.6%;16周服药保留率96.4%。结论 LEV添加治疗能显著减少RE患儿癫痫发作次数,并有助于改善患儿认知功能与生活质量,但应注意LEV对精神行为的影响。     

奥卡西平和左乙拉西坦治疗新诊断部分性发作癫疒间患儿的疗效分析

目的观察奥卡西平与左乙拉西坦对新诊断部分性发作癫疒间患儿的疗效和安全性。方法选择2011年1月至2013年12月新诊断部分性发作癫疒间患儿75例,随机分为2组。A组38例,给予奥卡西平治疗,剂量由10 mg/(kg·d)逐渐调整至最低有效量,最高为60 mg/(kg·d);B组37例,给予左乙拉西坦,剂量从5 mg/(kg·d)逐渐调整至最低有效量,最高为60 mg/(kg·d)。治疗12个月后,比较两组临床疗效、脑电图变化及不良反应。结果治疗后,A组的症状完全控制率(63.16%)、好转率(89.47%)与B组(安全控制率70.27%、好转率94.59%)比较差异无统计学意义(P>0.05);A组癫疒间样放电正常率(31.58%)、好转率(71.05%)与B组(37.84%、89.19%)比较差异无统计学意义(P>0.05);A组脑电背景α节律(9.67±1.36)与B组(9.84±1.31)比较差异无统计学意义(P>0.05);A组脑电图θ频段功率(30.64±7.66)比治疗前(20.67±6.36)明显增加(P<0.05),且高于B组(22.03±6.43),差异有统计学意义(P<0.05);A组不良反应发生率(20.05%)明显高于B组(2.70%),差异有统计学意义(P<0.05)。结论奥卡西平与左乙拉西坦治疗新诊断部分性发作癫疒间患儿均有效,但左乙拉西坦安全性更高。     

左乙拉西坦的国产仿制药替换治疗儿童癫痫的疗效及安全性研究北大核心CSCD

目的评价左乙拉西坦的国产仿制药替换原研药进口左乙拉西坦治疗儿童癫痫的疗效及安全性。方法回顾性分析2019年5月至2020年12月在广东省人民医院住院或门诊接受左乙拉西坦的国产仿制药替换治疗的154例癫痫患儿的临床资料,分析比较左乙拉西坦的国产仿制药替换原研药治疗的效果及安全性。结果154例患儿基线期癫痫控制率为77.3%(119/154),替换治疗6个月后癫痫控制率达83.8%(129/154),差异有统计学意义(P<0.05)。基线期与替换治疗6个月后癫痫发作频率比较差异无统计学意义(P>0.05)。替换治疗后无效患儿出现难治性癫痫比例高于有效患儿(P<0.05)。替换治疗前,仅1例患儿(0.6%)出现嗜睡;替换治疗后,3例患儿(1.9%)观察到轻度药物不良反应,包括头晕、嗜睡、易激惹、脾气暴躁,与替换治疗前比较差异无统计学意义(P>0.05)。结论左乙拉西坦的国产仿制药替换原研药进口左乙拉西坦治疗儿童癫痫是安全有效的,值得推广,但是需要更多的前瞻性随机对照试验来证实。