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左乙拉西坦和卡马西平单药治疗部分性癫痫发作的疗效与安全性

Efficacy and Safety of Levetiracetam and Carbamazepine as Monotherapy in Partial Seizures.

作者信息

Suresh Swaroop Hassan, Chakraborty Ananya, Virupakshaiah Akash, Kumar Nithin

机构信息

Cipla Ltd, 117/1, Anjanadri, Pantharapalya, Bangalore 560039, India.

Department of Pharmacology, Vydehi Institute of Medical Sciences and Research Centre, No. 82 EPIP Area, Whitefield, Bangalore 560037, India.

出版信息

Epilepsy Res Treat. 2015;2015:415082. doi: 10.1155/2015/415082. Epub 2015 Dec 20.

Abstract

Introduction. Levetiracetam (LEV) is a newer antiepileptic drug with better pharmacokinetic profile. Currently, it is frequently used for the treatment of partial seizures. The present study was undertaken to compare the efficacy and safety of LEV and Carbamazepine (CBZ) in partial epilepsy. Methods. This was a prospective, open labeled, randomized study. It was conducted in participants suffering from partial seizures after the approval of ethics committee and written informed consent. The first group received Tab LEV (500 to 3000 mg/day) and the second group received Tab CBZ (300 to 600 mg/day). The primary outcomes were efficacy and safety. The secondary outcome was the Quality of Life (QOL). Efficacy was assessed by comparing the seizure freedom rates at the end of 6 months. Safety profile was evaluated by comparing the adverse effects. QOL was assessed by QOLIE-10 scale. Results. The overall seizure freedom rate at the end of 6 months was 71.42% in CBZ group compared to 78.57% in LEV group (p = 0.2529). Both LEV and CBZ reported a similar incidence of adverse reactions. LEV group reported more behavioral changes like increased aggression and anxiety. Also, it showed better QOL compared to the CBZ group. Conclusion. LEV monotherapy and CBZ monotherapy demonstrated similar efficacy for treatment of partial epilepsy and were found to be well tolerated.

摘要

引言。左乙拉西坦(LEV)是一种新型抗癫痫药物,具有更好的药代动力学特性。目前,它常用于治疗部分性癫痫发作。本研究旨在比较左乙拉西坦和卡马西平(CBZ)治疗部分性癫痫的疗效和安全性。方法。这是一项前瞻性、开放标签、随机研究。在伦理委员会批准并获得书面知情同意后,对部分性癫痫发作患者进行研究。第一组服用左乙拉西坦片(500至3000毫克/天),第二组服用卡马西平片(300至600毫克/天)。主要结局指标是疗效和安全性。次要结局指标是生活质量(QOL)。通过比较6个月末的无癫痫发作率评估疗效。通过比较不良反应评估安全性。通过QOLIE - 10量表评估生活质量。结果。6个月末,卡马西平组的总体无癫痫发作率为71.42%,左乙拉西坦组为78.57%(p = 0.2529)。左乙拉西坦和卡马西平报告的不良反应发生率相似。左乙拉西坦组报告有更多行为改变,如攻击性增加和焦虑。此外,与卡马西平组相比,其生活质量更好。结论。左乙拉西坦单药治疗和卡马西平单药治疗在治疗部分性癫痫方面显示出相似的疗效,且耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/62f9/4698781/16b5140a1e1b/ERT2015-415082.001.jpg

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