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儿童、青少年和年轻成人耐药性癫痫的治疗效果和血清浓度:年龄小于和大于 12 岁患者的比较。

Efficacy and serum concentrations of perampanel for treatment of drug-resistant epilepsy in children, adolescents, and young adults: comparison of patients younger and older than 12 years.

机构信息

Division of Neurology, Saitama Children's Medical Center, 2-1 Shin-toshin, Chuou-ku, Saitama-city, Saitama 330-8777, Japan; Department of Pediatrics, The Jikei University School of Medicine, 3-19-18 Nishi-shinbashi, Minato-ku, Tokyo 105-8471, Japan.

Division of Neurology, Saitama Children's Medical Center, 2-1 Shin-toshin, Chuou-ku, Saitama-city, Saitama 330-8777, Japan; Department for Child Health and Human Development, Saitama Children's Medical Center, 2-1 Shin-toshin, Chuou-ku, Saitama-city, Saitama 330-8777, Japan.

出版信息

Seizure. 2019 Dec;73:75-78. doi: 10.1016/j.seizure.2019.10.023. Epub 2019 Nov 5.

Abstract

PURPOSE

Perampanel (PER) is a selective, non-competitive antagonist of the alpha-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid (AMPA) receptor. In Japan, PER is approved for patients with epilepsy who are at least 12 years old for the adjunctive treatment of primary generalised tonic-clonic seizures and partial-onset seizures (with or without secondary generalization). We surveyed the efficacy, adverse effects, and serum concentrations of PER, focusing especially on patients younger than 12 years of age.

METHODS

We retrospectively surveyed the clinical information of patients treated with PER and assessed the efficacy at 6 months after treatment initiation. We compared efficacy, adverse effects, and serum concentration in patients younger or older than 12 years of age. Responders were defined as those who experienced a ≥50% seizure reduction.

RESULTS

Eighty-four patients were enrolled. The average age of the younger group was 7.1 ± 3.3 (standard deviation) years compared to 16.4 ± 3.7 years in the older group. The responder rate was 42.9% (36/84). The responder rate did not differ between the two age groups (<12 years, 20/44, 45.4%; >12 years, 16/40, 40.0%; p = 0.78). The younger age group had a significantly lower concentration-to-dose (CD) ratio than the older age group (<12 years, 1849.8 ± 2209.3; >12 years, 3076.3 ± 3352.2, p = 0.02). Treatment-emergent adverse events (TEAEs) were observed in 22.6% (19/84) of patients, with the most common being somnolence (8/84, 9.5%).

CONCLUSION

PER may be an alternative to treat seizures in paediatric drug-resistant epilepsy. Serum concentrations of PER might be lower in patients younger than 12 years than in older patients.

摘要

目的

吡仑帕奈(PER)是一种选择性、非竞争性的 α-氨基-3-羟基-5-甲基-4-异恶唑丙酸(AMPA)受体拮抗剂。在日本,PER 被批准用于 12 岁及以上的癫痫患者,作为原发性全面强直阵挛发作和部分发作(伴或不伴继发全面性发作)的辅助治疗药物。我们调查了 PER 的疗效、不良反应和血清浓度,特别关注了年龄小于 12 岁的患者。

方法

我们回顾性调查了接受 PER 治疗的患者的临床资料,并评估了治疗开始后 6 个月的疗效。我们比较了年龄小于 12 岁和大于 12 岁的患者的疗效、不良反应和血清浓度。应答者定义为发作减少≥50%的患者。

结果

共纳入 84 例患者。年龄较小组的平均年龄为 7.1±3.3(标准差)岁,年龄较大组为 16.4±3.7 岁。应答率为 42.9%(36/84)。两组的应答率无差异(<12 岁组,20/44,45.4%;>12 岁组,16/40,40.0%;p=0.78)。年龄较小组的浓度-剂量(CD)比值明显低于年龄较大组(<12 岁组,1849.8±2209.3;>12 岁组,3076.3±3352.2,p=0.02)。22.6%(19/84)的患者出现治疗中出现的不良事件(TEAEs),最常见的是嗜睡(8/84,9.5%)。

结论

PER 可能是治疗儿童耐药性癫痫发作的一种选择。血清 PER 浓度在年龄小于 12 岁的患者中可能低于年龄较大的患者。

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