左乙拉西坦预防脑出血急性期癫痫发作的安全性和有效性

Sheherbano Jadoon, Imran Ahmed, Ibrar Saleem, Jalil Khan, Anusha Pervaiz, Pir Mubassar Shah, Shah Faisal
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摘要

背景:癫痫是脑内出血(ICH)患者的一个重要并发症,其特征是由于异常的脑部活动导致的无诱因的反复发作。在 ICH 急性期出现癫痫抽搐会恶化患者的预后和存活机会,因此找到一种安全有效的方法来预防癫痫发作至关重要。左乙拉西坦是一种吡咯烷酮衍生物,因其独特的作用机制、优异的耐受性和有利的药代动力学而备受关注,对各种类型的癫痫发作均有疗效:本研究旨在评估左乙拉西坦在预防 ICH 急性期癫痫发作方面的安全性和有效性,并确定其对此类患者神经系统预后的影响:2022 年 10 月至 2023 年 6 月期间,在巴基斯坦拉瓦尔品第的 Pak Emirates 军事医院开展了一项横断面调查,共涉及 85 名在症状出现 24 小时内经 CT 或 MRI 证实为自发性 ICH 的患者。纳入标准包括年龄在 18 岁或以上、患有各种形式 ICH 的成年患者,但不包括孤立性蛛网膜下腔出血、穿透性伤口损伤、凹陷性颅骨骨折或早期创伤后癫痫发作的患者。格拉斯哥昏迷量表(GCS)评分低于 6 分、血清肌酐水平大于 1.7 毫克/分升、有精神病史、无诱因癫痫发作、脑血管意外、脑外伤或在过去三年内患有脑炎的患者除外。患者接受首次左乙拉西坦负荷剂量(1,000 至 1,500 毫克),然后根据肾功能情况接受维持剂量(500 至 1,500 毫克,每 12 小时一次)。连续脑电图(cEEG)监测用于检测入院后至少72小时内的癫痫发作。主要结果是住院期间癫痫发作的发生率,次要结果是患者出院时的神经系统状况,采用改良朗肯量表(mRS)进行评估。数据采用描述性统计和卡方检验进行分析,P 值≤0.05 为具有统计学意义。分析使用 SPSS 25 版本:患者的平均年龄为 47.89 岁(SD=7.46),其中男性占 62.35%,女性占 37.65%。入院时平均 GCS 评分为 10.52(SD=2.13),平均 ICH 容量为 17.5 毫升(SD=3.4)。基线时,2.35%的患者 GCS 评分为 3-5,治疗后这一比例降至 0%。GCS评分为13-15分的患者比例从65.88%增至83.52%(P=0.3730)。有 10.58% 的患者在最初 7 天内出现癫痫发作,住院期间癫痫发作的总发生率为 20%。出院时,9.41% 的患者 mRS 评分为 0,mRS 评分为 2 的患者比例从 18.18% 显著增加到 37.64%(P=0.4086*)。严重残疾(mRS 评分 5 分)患者的比例从 22.72% 显著降至 5.68% (p=0.0094*):结论:左乙拉西坦能有效改善急性脑出血患者的神经功能预后,降低癫痫发作的发生率,且安全性可控。这些研究结果表明,左乙拉西坦可以成为控制 ICH 相关癫痫发作治疗策略的重要补充,从而有可能加强对患者的护理并改善健康状况。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and Efficacy of Levetiracetam for Prevention of Epileptic Seizures in Acute Phase of Intracerebral Bleeding
Background: Epilepsy, characterized by recurrent, unprovoked seizures due to anomalous brain activity, is a significant complication for patients with intracerebral hemorrhage (ICH). The onset of epileptic convulsions during the acute phase of ICH can worsen the patient's prognosis and survival chances, making it crucial to identify a safe and effective method to prevent these seizures. Levetiracetam, a pyrrolidone derivative, is noted for its unique mechanism of action, exceptional tolerability, and advantageous pharmacokinetics, making it efficacious against various types of seizures. Objective: This study aims to evaluate the safety and efficacy of levetiracetam in preventing epileptic seizures during the acute phase of ICH and to determine its impact on neurological outcomes in this patient population. Methods: A cross-sectional investigation was conducted between October 2022 and June 2023 at Pak Emirates Military Hospital in Rawalpindi, Pakistan, involving 85 patients with spontaneous ICH confirmed by CT or MRI within 24 hours of symptom onset. Inclusion criteria included adult patients aged 18 or older, with various forms of ICH, excluding isolated subarachnoid hemorrhage, penetrating wound injury, depressed skull fracture, or early posttraumatic seizure. Patients with a Glasgow Coma Scale (GCS) score of less than 6, serum creatinine level >1.7 mg/dL, history of psychosis, unprovoked seizures, cerebrovascular accidents, traumatic brain injuries, or encephalitis within the previous three years were excluded. Patients were administered an initial loading dose of levetiracetam (1,000 to 1,500 mg), followed by a maintenance dose (500 to 1,500 mg every 12 hours) based on renal function. Continuous electroencephalography (cEEG) monitoring was used to detect seizures for at least the first 72 hours of hospital admission. The primary outcome was the incidence of epileptic seizures during hospitalization, while the secondary outcome was the patient's neurological status at discharge, assessed using the Modified Rankin Scale (mRS). Data were analyzed using descriptive statistics and the Chi-square test, with a p-value of ≤0.05 considered statistically significant. Analyses were conducted using SPSS version 25. Results: The mean age of the patients was 47.89 years (SD=7.46), with 62.35% male and 37.65% female. The mean GCS score at admission was 10.52 (SD=2.13), and the mean volume of ICH was 17.5 ml (SD=3.4). At baseline, 2.35% of patients had GCS scores of 3-5, which improved to 0% after treatment. The percentage of patients with GCS scores of 13-15 increased from 65.88% to 83.52% (p=0.3730). Seizures within the first 7 days occurred in 10.58% of patients, and the overall seizure incidence during hospitalization was 20%. At discharge, 9.41% of patients had an mRS score of 0, and the percentage of patients with an mRS score of 2 increased significantly from 18.18% to 37.64% (p=0.4086*). The percentage of patients with severe disability (mRS score of 5) significantly decreased from 22.72% to 5.68% (p=0.0094*). Conclusion: Levetiracetam is effective in improving neurological outcomes and reducing the incidence of seizures in patients with acute intracerebral hemorrhage, with a manageable safety profile. These findings suggest that levetiracetam can be a valuable addition to therapeutic strategies for managing ICH-related seizures, potentially enhancing patient care and improving health outcomes.
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