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中国维吾尔族癫痫患儿左乙拉西坦的长期安全性、疗效和耐受性:回顾性分析。

Long-term safety, efficacy, and tolerability of levetiracetam in pediatric patients with epilepsy in Uygur, China: A retrospective analysis.

机构信息

Department of Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China; Institute of Clinical Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China.

Department of Neurology, Pediatric Patients's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China.

出版信息

Epilepsy Behav. 2021 Jul;120:108010. doi: 10.1016/j.yebeh.2021.108010. Epub 2021 May 5.

DOI:10.1016/j.yebeh.2021.108010
PMID:33964540
Abstract

PURPOSE

Levetiracetam is approved as an add-on therapy to treat refractory partial seizures in pediatric patients over four years old. The efficacy and safety in pediatric patients with epilepsy in Uygur, China, is unknown. Therefore, the objective of this study was to investigate the safety, efficacy, and tolerability of levetiracetam in pediatric patients with epilepsy in Uygur, China.

METHODS

This retrospective study compared the efficacy and safety of levetiracetam monotherapy and in combination with other antiseizure medications (ASMs) in 1055 pediatric patients with epilepsy treated with levetiracetam. The seizure frequencies at 1, 2, and 3 years after starting levetiracetam therapy were recorded and compared with the baseline yearly frequency. Safety variables included the incidence and type of adverse reactions.

RESULTS

A total of 680 (64%) pediatric patients responded to levetiracetam therapy with a more than 50% reduction in the frequency of seizures. Seizure-free rates increased over time, 13%, 15%, and 18% at 1, 2, and 3 years, respectively. The number of baseline ASMs and the order of levetiracetam introduction were highly significant, impacting the likelihood of seizure remission during a 3-year follow-up period (p < 0.001). During levetiracetam treatment, 233 pediatric patients (22%) experienced at least one adverse reaction.

CONCLUSION

These significant findings indicate that levetiracetam is likely to become a widely prescribed ASM for epilepsy in pediatric clinical practice because of its long-term safety, efficacy, and tolerability.

摘要

目的

左乙拉西坦被批准作为附加疗法,用于治疗 4 岁以上儿童难治性部分性癫痫发作。该药在中国维吾尔族儿童癫痫患者中的疗效和安全性尚不清楚。因此,本研究旨在探讨左乙拉西坦在中国维吾尔族儿童癫痫患者中的安全性、疗效和耐受性。

方法

本回顾性研究比较了左乙拉西坦单药治疗和联合其他抗癫痫药物(AEDs)治疗 1055 例接受左乙拉西坦治疗的癫痫儿童的疗效和安全性。记录左乙拉西坦治疗开始后 1、2 和 3 年的癫痫发作频率,并与基线年频率进行比较。安全性变量包括不良反应的发生率和类型。

结果

共有 680 例(64%)儿科患者对左乙拉西坦治疗有反应,癫痫发作频率降低了 50%以上。无癫痫发作率随时间增加,分别为 1 年、2 年和 3 年时的 13%、15%和 18%。基线 AEDs 的数量和左乙拉西坦引入的顺序对癫痫缓解的可能性有显著影响,在 3 年随访期间(p<0.001)。在左乙拉西坦治疗期间,233 例(22%)儿科患者出现至少一次不良反应。

结论

这些重要发现表明,左乙拉西坦可能成为儿科临床实践中广泛应用的抗癫痫药物,因为其长期安全性、疗效和耐受性。

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