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左乙拉西坦与苯妥英钠用于开颅术后癫痫预防的疗效和安全性比较。

Comparison of Efficacy and Safety of Levetiracetam Versus Phenytoin for Post-craniotomy Seizure Prophylaxis.

作者信息

Faghihjouibari Morteza, Khadivi Masoud, Rouhani Reza, Pazoki Toroudi Hamidreza, Nazari Masoud, Sadeghian Mahgol, Abolfazli Mehdi

机构信息

Department of Neurosurgery, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Department of Neurosurgery, Amiralmomenin Hospital, Zabol University of Medical Sciences, Zabol, Iran.

出版信息

Med J Islam Repub Iran. 2023 Feb 14;37:7. doi: 10.47176/mjiri.37.7. eCollection 2023.

Abstract

Superiority of levetiracetam over phenytoin for postcraniotomy seizure prophylaxis in patients with a supratentorial brain tumor is controversial. We aimed to evaluate the efficacy of levetiracetam versus phenytoin for postcraniotomy seizure prophylaxis in supratentorial brain tumor. In a randomized controlled trial study, 80 patients with a supratentorial brain tumor who underwent craniotomy were allocated to levetiracetam or phenytoin group, 40 patients each. Seizure prophylaxis was started 5 days before the surgery and continued until 90 days after surgery. Phenytoin group received 100 mg oral phenytoin 3 times a day. The levetiracetam group received 500 mg oral levetiracetam 2 times a day. The primary outcome was the incidence of postcraniotomy seizures. The secondary outcome measure was the safety profile of the drugs. All patients of the phenytoin group and 39 patients of levetiracetam completed the study. Two seizures developed in the study population, 1 in the phenytoin group (2.5%) and 1 in the levetiracetam group (2.6%) ( = 0.710). Renal or hepatic dysfunction was not observed in any patients. Wound hematoma was seen in 5 patients (12.5%) of the phenytoin and 6 patients (15.4%) of the levetiracetam group ( = 0.481). Skin rash developed in 3 patients (7.5%) of the phenytoin group and no patient of the levetiracetam group ( = 0.132). Thrombocytopenia was detected in 1 patient of the phenytoin group (2.5%) and no patient of the levetiracetam group ( = 0.511). None of the adverse events led to drug withdrawal. These results reveal no superiority of levetiracetam over phenytoin for postcraniotomy seizure prophylaxis in supratentorial brain tumor.

摘要

左乙拉西坦与苯妥英钠相比,在幕上脑肿瘤患者开颅术后预防癫痫发作方面的优越性存在争议。我们旨在评估左乙拉西坦与苯妥英钠在幕上脑肿瘤开颅术后预防癫痫发作的疗效。在一项随机对照试验研究中,80例接受开颅手术的幕上脑肿瘤患者被分配到左乙拉西坦组或苯妥英钠组,每组40例。术前5天开始预防癫痫发作,并持续至术后90天。苯妥英钠组患者每天口服苯妥英钠100毫克,3次。左乙拉西坦组患者每天口服左乙拉西坦500毫克,2次。主要结局是开颅术后癫痫发作的发生率。次要结局指标是药物的安全性。苯妥英钠组所有患者和左乙拉西坦组39例患者完成了研究。研究人群中出现了2次癫痫发作,苯妥英钠组1次(2.5%),左乙拉西坦组1次(2.6%)(P = 0.710)。未在任何患者中观察到肾功能或肝功能障碍。苯妥英钠组5例患者(12.5%)和左乙拉西坦组6例患者(15.4%)出现伤口血肿(P = 0.481)。苯妥英钠组3例患者(7.5%)出现皮疹,左乙拉西坦组无患者出现皮疹(P = 0.132)。苯妥英钠组1例患者(2.5%)检测到血小板减少,左乙拉西坦组无患者出现血小板减少(P = 0.511)。没有不良事件导致停药。这些结果表明,在幕上脑肿瘤开颅术后预防癫痫发作方面,左乙拉西坦并不优于苯妥英钠。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2ba/10134079/228fae9595a1/mjiri-37-7-g001.jpg

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