一线抗癫痫药对儿童疗效相当

圣迭戈——在美国癫痫学会(AES)年会上报告的一项回顾性队列研究结果显示，新发局限性癫痫患儿最常用的2种抗癫痫药物(AED)左乙拉西坦和奥卡西平在疗效方面未见明显差异。

费城儿童医院儿童的Jenny L. Wilson博士指出，此前这两种药物从未在患儿人群中进行比较研究。虽然这项研究并非随机对照试验，但仍不失为比较这两种患儿常用AED疗效的好方法。研究结果表明，两种药物保留率相似，其疗效可与老的AED相媲美。保留率综合了AED的有效性和耐受性，是一种判断患者预后的实用指标，也是临床医生决定AED是否作为一线用药很好的初始数据。

 
Jenny Wilson博士
 
Wilson博士及其同事Sudha Kilaru Kessler博士查阅了2008年1月~2010年6月在该院首诊3个月内确诊的221例1~17岁癫痫患儿的病历。他们排除了癫痫持续状态、发病时住院超过2天、随访数据不足6个月、采用Kaplan-Meier方法评估药物失败率(定义为中止首选AED治疗或添加第二种AED)的患儿。患儿首次发作中位年龄为5.7岁，首次AED治疗中位年龄为6.5岁。

研究者报告了左乙拉西坦治疗者1,435人·月和奥卡西平治疗者2,137人·月的随访结果。结果显示，左乙拉西坦组和奥卡西平组AED失败率分别为2.8/100人·月和1.7/100人·月，两者未见显著差异[危险比(HR)，0.7；P=0.11]。就所有儿童而言，6个月和40个月首选AED保留率分别为76%和58%，由于耐受性不佳导致的药物治疗失败早于因疗效不佳所致的药物失败(中位时间1.7个月vs. 4.56个月)。

单变量分析显示，治疗失败的原因包括缺乏疗效(12.4/100人·月)、耐受性不佳(26.2/100人·月)和两者兼之(17.8/100人·月)。研究者指出，基于以往经验，具有行为问题的患儿左乙拉西坦治疗失败的几率稍大，因为该药物具有行为方面的副作用。但研究结果显示，两种药物失败率非常相似，未见显著差异。

研究者认为，总体研究结果表明，左乙拉西坦和奥卡西平均为新发局限性癫痫患儿非常好的一线用药。但同时也强调，上述结果尚需随机试验加以证实。

该研究由美国国立卫生研究院(NIH)资助，研究者声称无相关利益冲突。

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By: DOUG BRUNK, Clinical Neurology News Digital Network

SAN DIEGO  – There are no discernible differences in the efficacy of the two most common antiepileptic drugs used in children with new-onset focal epilepsy, results from a retrospective cohort study found.

The drugs – levetiracetam and oxcarbazepine – had never been compared in a pediatric population before, Dr. Jenny L. Wilson said in an interview during a poster session at the annual meeting of the American Epilepsy Society.

"This is not a randomized, controlled trial, but it’s still a very good measure of effectiveness of two very commonly used antiepileptic drugs for pediatric epilepsy," said Dr. Wilson, a child neurology resident at the Children’s Hospital of Philadelphia. "We’re showing that the retention rates are similar, and that efficacy is comparable to studies of older antiepileptic drugs. Retention rate is a practical outcome measure which takes into account the efficacy and tolerability of an antiepileptic medication. It’s some initial data for clinicians to consider when they’re making decisions about a first-line antiepileptic drug."

Dr. and her colleague, Dr. Sudha Kilaru Kessler, at the university reviewed the medical records of 221 children aged 1-17 years whose epilepsy was diagnosed within 3 months of their first visit to Children’s Hospital between January 2008 and June 2010. They excluded patients with status epilepticus, those who were hospitalized for more than 2 days at presentation, and those who had less than 6 months of follow-up data available, and used Kaplan-Meier methods to estimate the rates of drug failure, which was defined as discontinuation of the first antiepileptic drug (AED) or addition of a second AED.

Of the 221 patients, the median age at first seizure was 5.7 years, and the median age at initiation of AED therapy was 6.5 years.

The researchers reported findings from 1,435 person-months for levetiracetam and 2,137 person-months for oxcarbazepine. The rate of AED failure was 2.8/100 person-months in the levetiracetam group and 1.7/100 person-months in the oxcarbazepine group, a difference that did not reach statistical significance (hazard ratio, 0.7; P = .11). Among all children, the probability of remaining on the first AED was 76% at 6 months and 58% at 40 months, and drug failures due to lack of tolerability occurred sooner than failures due to a lack of efficacy (a median of 1.7 months vs. 4.56 months).

Univariate analysis revealed the following reasons for failure: lack of efficacy (12.4/100 person-months), tolerability (26.2/100 person-months), and both (17.8/100 person-months). "In my experience, kids with behavioral problems tend to fail levetiracetam a little bit more because of behavioral side effects," Dr. Wilson commented. "We did not see significant differences in that regard. The failure rates were very similar."

She concluded that the overall study results suggest that levetiracetam and oxcarbazepine "are very good first-line agents for new diagnosis of focal epilepsy in children" and emphasized that a randomized trial is warranted to confirm the findings.

The study was funded by the National Institutes of Health. The researchers stated that they had no relevant financial disclosures.