左乙拉西坦治疗60例小儿癫痫的疗效和安全性分析

目的探讨左乙拉西坦在小儿癫痫治疗中的疗效和安全性。方法从我院2013-06—2014-06小儿神经内科专科门诊部收治的癫痫患儿中随机性抽取60例作为研究对象,采用开放性自对照随访研究方法。60例患儿均给予左乙拉西坦口服治疗,随访6~10个月,观察治疗前后癫痫发作频率变化、脑电图改变情况以及患儿治疗期间的不良反应,评价左乙拉西坦治疗小儿癫痫的疗效和安全性。结果本组患儿均成功获得随访,治疗后完全控制26例,有效20例,无效12例,加重2例,总有效率76.67%,且不同类型癫痫患儿治疗后的发作次数明显低于治疗前(P0.01)。脑电图检查痫样放电消失31例,痫样放电减少50%以上10例,痫样放电减少25%~49%9例,痫样放电无变化7例,痫样放电增加3例。本组治疗期间18例发生不良反应,不良反应发生率30.00%,主要表现为情绪异常、嗜睡乏力、皮疹等症状,给予对症治疗后均得到缓解,无严重影响治疗的不良反应。结论左乙拉西坦治疗儿童癫痫的疗效确切,不良反应少,是一种安全有效的药物。     

丙戊酸钠联合左乙拉西坦治疗小儿癫痫临床分析

目的 研究丙戊酸钠结合左乙拉西坦治疗小儿癫痫的有效性及安全性.方法 将2015-06—12我院儿科收治的120例小儿癫痫患儿为研究对象,按照数字随机分组法分成3组,给予不同药物进行治疗,分别为丙戊酸钠组(40例)、左乙拉西坦组(40例)与联合治疗组(40例).观察3组疗效、相关实验室指标与安全性.结果 丙戊酸钠组治疗总有效率77.5%,左乙拉西坦组为72.5%,联合治疗组为92.5%,联合治疗组优于其他2组,差异有统计学意义(χ2=2.37、3.92,P均<0.05);3组治疗前后血钙与血磷水平比较,治疗后联合治疗组血钙与血磷水平均优于其他2组,差异有统计学意义(血钙t=1.14、2.51,血磷t=1.35、1.73,P均<0.05).联合治疗组不良反应率5.0%,优于丙戊酸钠组的12.5%与左乙拉西坦组的15.0%,差异有统计学意义(χ2=1.524、1.473,P<0.05).结论 丙戊酸钠联合左乙拉西坦治疗小儿癫痫的疗效更好,安全性更高,值得临床推广.     

左乙拉西坦单药治疗小儿癫痫的自身对照研究

目的研究左乙拉西坦作为单药治疗不同类型癫痫患儿的临床疗效和安全性。方法采用前瞻性研究,对62例不同类型癫痫患儿进行左乙拉西坦单药治疗。左乙拉西坦起始剂量为20 mg/(kg.d),分两次服用,每两周增加10 mg/(kg.d),维持剂量30～40 mg/(kg.d)。稳定期:维持加量期12周,每个月观察1次,以治疗前3个月的发病频率为基础,完成了6个月的观察期,随访6～24个月(平均随访12.8个月),观察发作频率的变化及不良反应。结果 62例入选患儿,完全控制发作38例,占61.3%,显效8例,占12.9%;有效9例,占14.5%;无效4例,占6.5%;加重3例,占4.8%。总有效率为88.7%,两年治疗保留率为72%。左乙拉西坦治疗前后发作频率改变有统计学意义(P0.005)。结论左乙拉西坦作为单药治疗小儿各型癫痫有良好疗效及安全性。     

左乙拉西坦治疗成人癫痫的疗效及安全性分析

目的分析左乙拉西坦在成人癫痫患者中的疗效、耐受性及安全性。方法选取我院2013-02—2014-06收治的98例癫痫患者为研究对象,随机分为试验组(LEV治疗)和对照组(常规用药)各49例,疗程40d,观察疗效及不良反应。结果观察组有效率81.6%,对照组为61.2%,2组疗效比较差异有统计学意义(P0.05)。2组指标异常、厌食、嗜睡等不良反应差异无统计学意义(P0.05)。个别患者出现皮疹、白细胞下降症状并不是应用左乙拉西坦造成的。结论左乙拉西坦(LEV)作为一种新型药物,安全性较高,在癫痫治疗的初、中期患者耐受性好,单独使用其治疗效果也十分显著。     

左乙拉西坦治疗不同类型小儿癫痫的临床疗效

目的探析左乙拉西坦治疗不同类型小儿癫痫的临床疗效。方法选择我院2012-03—2015-06收治的81例小儿癫痫患者进行研究,随机分为观察组(n=41)与对照组(n=40)。对照组应用丙戊酸钠治疗,观察组在对照组基础上加用左乙拉西坦,比较2组治疗前后癫痫发作频率、治疗总有效率及不良反应发生率。结果 2组治疗前发作频率组间差异无统计学意义(P0.05),治疗后2组发作频率均降低,组内前后差异有统计学意义(P0.05),同时观察组治疗后的发作频率低于对照组,组间比较差异有统计学意义(P0.05),提示观察组发作频率降低幅度更大。观察组不同类型癫痫患者的治疗总有效率为90.2%(37/41),对照组为72.5%(29/40),观察组明显更高,差异有统计学意义(P0.05)。观察组不良反应发生率为31.7%(13/41),对照组为25.0%(10/40),差异无统计学意义(P0.05)。结论左乙拉西坦在不同类型小儿癫痫临床治疗中的应用可大幅降低发作频率,利于强化治疗效果,且安全可靠,可长期用药,值得推广。     

左乙拉西坦治疗各型癫100例临床疗效观察

目的观察左乙拉西坦（开普兰）治疗各型癫痫的疗效。方法用开放性试验的方法对100例癫痫患者进行了添加转单药以及首诊单药的开普兰治疗,观察其疗效及不良反应。结果总有效率46．0％,控制率15．0％,对各型癫痫均有效。不良反应出现率17．0％。结论开普兰是一种安全、有效的抗癫痫药物,对各型癫痫均有效。     

首选左乙拉西坦治疗儿童癫痫的疗效和安全性

<正>癫痫是儿童时期神经系统最常见的疾病之一,反复发作可影响精神和智能发育,给家庭和社会带来沉重的负担。左乙拉西坦(Levetiracetam,LEV)商品名开浦兰,是新型的广谱抗癫痫药,自2007年3月在中国上市以来广泛用于临床。在中国,LEV适应证为4岁及4岁以上儿童和成人癫痫单药及添加治疗。亦有文献报道LEV用于治疗4岁的患儿[1]。为探讨LEV单药治疗儿童癫痫的疗效和安全性,我们应用     

左乙拉西坦在癫痫治疗中的作用

详细总结新型抗癫痫药物左乙拉西坦的药物代谢动力学特点、药物相互作用、抗癫痫作用机制、对成人及儿童各种不同发作类型癫痫的添加治疗及单药治疗研究进展、安全性评价及常见不良反应、特异质性不良事件、认知功能及生活质量影响。结论该药具有理想的药动学特性、较高的安全性及抗癫痫效能,对认知功能无明显损害,适应证扩大后已经可用于16岁以上人群部分性发作癫痫的单药治疗、全面性发作癫痫中某些特定发作类型的添加治疗。     

左乙拉西坦单药治疗各类癫痈的疗效

左乙拉西坦是一种新型作用机制的抗癫痫药物,其抗痢机制可能是通过影响突触囊泡蛋白SV2A来实现。本文就该药物单一治疗各类癫痫（新诊断癫痫、部分性发作、全面性发作及手术后癫痫等）的疗效和耐受性研究做介绍。     

左乙拉西坦治疗癫痫的疗效及安全性的随访分析

目的观察左乙拉西坦(LEV商品名Keppra)单药或添加治疗儿童及成人各类型癫痫的临床疗效及安全性。方法采用开放性自身对照的研究方法,以四川大学华西医院神经内科自2008年2月～2009年6月收治的80例门诊和住院癫痫患者为研究对象,对其进行6个月的LEV治疗并随访,观察LEV对癫痫患者的疗效及不良反应。结果80例随访观察对象接受LEV治疗≥6个月后,达到完全控制的为15例,占18.8%;LEV治疗有效的35例,占43.7%;而有30例患者对LEV治疗无效,占37.5%,即总应答率为62.5%。总体上LEV添加或单药治疗各种类型癫痫临床效果肯定,患者年龄、病程、是否有头部影像学异常对其疗效影响不大,单药治疗或添加治疗癫痫的临床疗效亦无统计学差异,而与癫痫的类型相关,LEV对复杂部分性发作继发全面性发作疗效最好(应答率79.5%)。随访过程中失访6例(7.8%),出现不良反应9例(11.3%)。结论LEV作为一种新型抗癫痫药物,单药治疗或添加治疗成人及儿童各种类型癫痫具有较好的疗效和安全性。     

Behavioral side-effects of levetiracetam in children with epilepsy: A systematic review

PurposeChildren with epilepsy are more likely to have behavioral problems compared to children without epilepsy. Literature suggests that levetiracetam leads to behavioral side-effects in children with epilepsy. The objective of this study is to provide a better overview of the frequency and variety of behavioral side-effects, which can be initiated by levetiracetam therapy in children with epilepsy.MethodElectronic databases used in the search were PubMed, Medline, Cochrane and Embase. Studies were eligible for inclusion when they included children from one month to 18 years of age with a diagnosis of epilepsy, used levetiracetam, had other AEDs on a stable regimen for at least two months, reported about behavioral side-effects and had a follow-up of at least two weeks. Quality assessments and data collection were carried out for all eligible studies.ResultsThirteen studies, including 727 patients using levetiracetam, were included in this systematic review. Three randomized controlled trials showed a total of 62 behavioral side-effects in 203 patients, effects which led to discontinuation of levetiracetam in only two of 102 patients (2.0%). Hostility, nervousness and aggression were reported mostly. Meta-analysis showed a statistically significant relative risk of 2.18 for the total number of behavioral side-effects for levetiracetam versus placebo. Observational studies showed mixed results with both behavioral deteriorations and improvements following levetiracetam.ConclusionBased on the findings in this systematic review, children using levetiracetam have a risk of developing several behavioral side-effects such as aggression, hostility and nervousness compared to children who do not use levetiracetam.     

Efficacy and tolerability of levetiracetam in children younger than 4 years: a retrospective review

PURPOSE: To review our experience of the efficacy and tolerability of levetiracetam (LEV) in children younger than 4 years. METHODS: We used retrospective chart review to identify 122 children with seizures who were younger than 4 years and followed for >or=6 months. Efficacy was evaluated on the basis of the occurrence and durability of seizure remission. Tolerability was based on parent- and patient-reported side effects. RESULTS: Seventy (57%) subjects achieved seizure remission, and 52 (43%) did not. In univariate analysis, those achieving seizure remission were more likely to have partial epilepsy, require lower maintenance doses of LEV, and have fewer than two seizures per month at initiation of the medication. Only seizure frequency at initiation of LEV remained significant in multivariate analysis. The median duration of seizure freedom (8.9 month) was not influenced by age, epilepsy type, gender, or pretreatment seizure frequency. The dose of LEV was the only significant predictor of the duration of seizure remission, with longer duration of seizure remission seen in those taking <30 mg/kg/day compared with those taking > 30 mg/kg/day (median, 12.8 months vs. 3 months; p<0.0001). Side effects of LEV occurred in 34% of subjects but required discontinuation in only 16%, most commonly because of behavioral disturbances. CONCLUSIONS: LEV is an effective medication in children younger than 4 years and at doses lower than previously reported. It also well tolerated, suggesting that it represents an important option for the treatment of epilepsy in this age group.     

左乙拉西坦联合盐酸舍曲林治疗癫痫伴抑郁患儿的疗效观察

目的 探讨左乙拉西坦联合盐酸舍曲林治疗癫痫伴抑郁症儿童的临床疗效。方法 回顾性分析112例6~15岁癫痫伴抑郁症的临床资料,按年龄分为学龄组（6~12岁,56例）和少年组（13~15岁,56例）,评估治疗前后癫痫发作频率、认知功能（WISC-CR）、汉密尔顿抑郁量表17项（HAMD-17）、生活质量、身体质量指数（BMI）、不良反应发生率。结果 与治疗前相比,两组治疗6、12个月,癫痫发作频率、认知功能、HAMD-17评分、生活质量均显著改善（P<0.05）;同时,学龄组癫痫发作频率、认知功能、HAMD-17评分、生活质量均显著优于少年组（P<0.05）;两组治疗后BMI、不良反应发生率无统计学差异（P>0.05）。结论 采用左乙拉西坦联合盐酸舍曲林治疗癫痫伴抑郁症儿童可获得显著的疗效,其中学龄组疗效优于少年组。     

Pharmacokinetics of levetiracetam in infants and young children with epilepsy

PURPOSE: To assess the single-dose pharmacokinetics of levetiracetam and its major metabolite ucb L057 in infants and young children with epilepsy. METHODS: Eligible patients with a stable regimen of antiepileptic medications received a single oral dose of levetiracetam 20 mg/kg administered as a 10% oral solution followed by a 24-hour pharmacokinetic evaluation. RESULTS: Thirteen subjects (age 2.3-46.2 months) enrolled and received levetiracetam; 12 provided evaluable pharmacokinetic data. Levetiracetam was rapidly absorbed and reached peak plasma concentration (t(max)) 1.4 +/- 0.9 hours after dosing. The mean half-life (t(1/2)) of levetiracetam was 5.3 +/- 1.3 hours, and the apparent clearance was 1.46 +/- 0.42 mL/min/kg. Graphical differences were observed among three age subgroups (1 to <6 months, 6 to <24 months, and 24 to <48 months); however, statistical analysis was limited due to each subgroup's small sample size. No significant gender differences were detected. Treatment-emergent adverse events were seen in three patients (23.1%) but were not considered to be related to levetiracetam. CONCLUSIONS: The mean t(1/2) of levetiracetam was shorter and its apparent clearance was more rapid for infants and young children than that previously reported for adults. When determining dosage, age-dependent drug clearance should be considered; these findings suggest that a larger dose of levetiracetam (corrected for body weight) needs to be considered for infants and young children with epilepsy than that given to adults with epilepsy. A single dose of levetiracetam was well tolerated in this study population.     

Efficacy and tolerability of levetiracetam in children with epilepsy

Objective: To assess the efficacy and tolerability of levetiracetam (Lev) in children with epilepsy. Methods: Open-label observational, prospective, single arm, non-interventional study examining patients (?14 years) with epilepsy, receiving mono- or combination therapy with levetiracetam. Levetiracetam was started at a dose of approximately 10 mg/kg/day. The dose was titrated up with 10 mg/kg increments if seizures were poorly controlled but the maximum daily dose could not be more than 60 mg/kg/day. Documented were seizure type and frequency, levetiracetam dose and side effects. Results: 120 patients (39.3% females, mean age 4.5 ± 3.9 years) were enrolled. Average duration of follow-up was 10.3 ± 3.5 months. At study endpoint, 64.8% of patients got seizure free and 83.0% got a seizure reduction of ?50%. Observed side effects were somnolence, dysphoria, nervousness, dystrophy, somnipathy, asitia, debilitation, etc. and the incidence rate in the study was 47.5%. Four (3.3%) of 120 patients withdrew because of intolerance of side effects. The estimated one year retention rate of levetiracetam was 73.3%. Poor effect was the most common reason for withdrawal. Conclusions: In our study, it seemed that levetiracetam was safe and effective for a wide range of epileptic seizures in children with epilepsy.     

Randomized-controlled trials of levetiracetam as an adjunctive therapy in epilepsy of multiple seizure types

This meta-analysis aimed to systematically collect and synthesize the current evidence regarding the efficacy and tolerability of levetiracetam (LEV) as an adjunctive therapy for adults and children suffering from idiopathic and secondary epilepsy of multiple seizure types. We selected randomized-controlled trials (RCT) of LEV as an adjunctive therapy in epilepsy according to predefined criteria. Outcome measures included a ⩾50% reduction in seizure frequency, seizure freedom, and adverse events. Thirteen RCT were analyzed. Results showed that the efficacy of adjunctive LEV was superior to placebo both in achieving ⩾50% reduction in seizure frequency (pooled odds ratio [OR] 3.36, 95% confidence interval [CI] 2.78–4.07, Z = 12.46; p < 0.00001) and seizure freedom (pooled OR 4.72, 95% CI 2.96–7.54, Z = 6.50; p < 0.00001). The heterogeneity was mild (chi-squared = 12.28, I² = 2% in ⩾50% reduction in seizure frequency, and chi-squared = 0.49, I² = 0% in seizure freedom). Subgroup analysis suggested similar effects across different dosages in adults. The incidence of adverse reactions was not significantly different between the LEV group and the placebo group. The adverse events of relatively high incidence in the LEV group included somnolence, agitation, dizziness, asthenia, and infection. Incidence of serious adverse reaction such as rash and white blood cells and platelets decreasing was quite low. Adjunctive therapy with LEV was superior to placebo in reducing the frequency of seizures in patients with partial and idiopathic generalized epilepsy with effect in both adults and children, and demonstrated good tolerance in patients with epilepsy.     

丙戊酸钠联合左乙拉西坦治疗小儿癫痫的疗效

目的探讨丙戊酸钠联合左乙拉西坦治疗小儿癫痫的临床疗效。方法将92例小儿癫痫患者随机分为对照组和实验组,在丙戊酸钠治疗基础上,对照组联合托吡酯治疗;实验组联合左乙拉西坦治疗。结果实验组总有效率93.5%高于对照组78.3%,治疗前,2组患者血钙和血磷水平无显著差异(P0.05);但治疗后实验组血钙水平(2.39±0.36)mmol/L、血磷水平(1.45±0.36)mmol/L均低于对照组(2.07±0.18)mmol/L、(1.21±0.15)mmol/L(均P0.05)。结论丙戊酸钠、左乙拉西坦联合用药治疗小儿癫痫疗效显著,且对钙、磷代谢影响较小,安全性高,临床值得应用。     

Hair loss with levetiracetam in five patients with epilepsy

PurposeTo report cases of hair loss with levetiracetam (LEV) in epilepsy patient and summarise their demographic and clinical features.MethodAll patients reported attended the epilepsy outpatient clinic of the West China Hospital, Sichuan University. Demographic and clinical information was obtained from medical records and by interview. All the patients were under regular follow up.ResultsFive epilepsy patients (4 females and 1 male) are reported. All developed hair loss within two months of starting LEV treatment. Three had idiopathic epilepsy, two symptomatic epilepsy. Three patients received LEV monotherapy, two combination treatment. None decided to switch away from LEV to another drug after developing hair loss, although the dose of LEV was reduced in one patient.ConclusionHair loss may be a rare side effect of LEV treatment in patients with epilepsy. LEV-related hair loss appears reversible if the dose is reduced or treatment is stopped.