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卡马西平和奥卡西平对局灶性癫痫患者血清神经元特异性烯醇化酶的影响:一项随机对照试验。

Effect of carbamazepine and oxcarbazepine on serum neuron-specific enolase in focal seizures: A randomized controlled trial.

作者信息

Maiti Rituparna, Mishra Biswa Ranjan, Sanyal Soham, Mohapatra Debadatta, Parida Sansita, Mishra Archana

机构信息

Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.

Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.

出版信息

Epilepsy Res. 2017 Dec;138:5-10. doi: 10.1016/j.eplepsyres.2017.10.003. Epub 2017 Oct 6.

DOI:10.1016/j.eplepsyres.2017.10.003
PMID:29028517
Abstract

Neuron-specific enolase (NSE) is the most investigated biomarker in the context of epilepsy and brain damage. The present study was conducted to investigate the change in serum NSE in patients with focal seizure and the effect of carbamazepine and oxcarbazepine on serum NSE. The present study is a randomized, open-label, parallel design clinical trial (ClinicalTrials.gov Identifier: NCT02705768) conducted on 60 patients of focal seizure. After recruitment, detailed history, clinical evaluations including Chalfont-National Hospital seizure severity scale (NHS3), Quality of Life in Epilepsy Inventory (QOLIE-31) and serum NSE estimation were done at baseline. Thirty healthy volunteers were recruited for a baseline evaluation of serum NSE. After randomization, one group received tablet oxcarbazepine and another group received tablet carbamazepine. At 4 weeks follow-up, all the parameter were reassessed. Serum NSE level was found to be significantly increased in patients with focal seizure in comparison to healthy volunteers. In both drug groups, serum NSE decreased significantly but the reduction in carbamazepine group (1.43; 95%CI: 0.18-2.67; p=0.025) was significantly higher than oxcarbazepine group.NHS3 score, score in all seven domains of QOLIE-31 and final QOLIE-31 score improved significantly in both the groups. In conclusion, serum NSE increases in the patients with focal seizure within 48h of a seizure episode. Therapy with carbamazepine and oxcarbazepine can decrease serum NSE level but the reduction is significantly higher with carbamazepine. Therapy with both the drugs can decrease the severity of epilepsy and improve the quality of life but adverse events were more with carbamazepine.

摘要

神经元特异性烯醇化酶(NSE)是癫痫和脑损伤领域研究最多的生物标志物。本研究旨在调查局灶性癫痫患者血清NSE的变化以及卡马西平和奥卡西平对血清NSE的影响。本研究是一项随机、开放标签、平行设计的临床试验(ClinicalTrials.gov标识符:NCT02705768),对60例局灶性癫痫患者进行。招募后,在基线时进行详细病史、包括查尔方特-国立医院癫痫严重程度量表(NHS3)、癫痫患者生活质量量表(QOLIE-31)在内的临床评估以及血清NSE测定。招募30名健康志愿者进行血清NSE的基线评估。随机分组后,一组接受奥卡西平片,另一组接受卡马西平片。在4周随访时,重新评估所有参数。发现局灶性癫痫患者的血清NSE水平与健康志愿者相比显著升高。在两个药物组中,血清NSE均显著下降,但卡马西平组的下降幅度(1.43;95%CI:0.18-2.67;p=0.025)显著高于奥卡西平组。两组的NHS3评分、QOLIE-31所有七个领域的评分以及最终QOLIE-31评分均显著改善。总之,局灶性癫痫患者在癫痫发作后48小时内血清NSE升高。卡马西平和奥卡西平治疗可降低血清NSE水平,但卡马西平的降低幅度显著更高。两种药物治疗均可降低癫痫严重程度并改善生活质量,但卡马西平的不良事件更多。

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