Batino Laurence K J, Escabillas Cyrus G, Navarro Jose C
Department of Neurology, Zeenat Qureshi Stroke Institute, Jose R. Reyes Memorial Medical Center, Manila, Philippines.
Brain Behav. 2024 Dec;14(12):e70158. doi: 10.1002/brb3.70158.
We aimed to evaluate the safety of intravenous edaravone for the treatment of acute ischemic stroke among Filipino patients. The study, categorized as Phase IV, spans from December 2022 to November 2023. The primary objective is to document side effects and serious adverse events during the 14-day edaravone infusion period.
The protocol gained approval from the Institutional Review Board, and participants provided written consent. Inclusion criteria involved patients aged 18-70 with acute ischemic stroke within 24 h. Exclusion criteria included extremes of age, pregnancy, severe hepatic impairment, and participation in other clinical trials. Edaravone was administered for 14 days, underwent continuous monitoring, and adverse events were actively recorded.
Out of 64 enrolled patients, 58 completed the treatment, while 4 did not finish, and 2 dropped out. The majority were male (n = 35), median age of 53.5 years, and 81.03% exhibited moderate stroke severity. Two patients reported headaches, and one reported dizziness. No serious adverse events or other untoward effects were documented. Dropouts, attributed to a low ejection fraction, showed normal laboratory results and no side effects during edaravone infusion. Thrombolytic therapy was given to 37.93% of patients.
Our study contributes insights into edaravone's safety, revealing a favorable profile with mild side effects, aligning with existing literature. Notably, no serious adverse events occurred, emphasizing edaravone's tolerability. Headache and dizziness, which were the common side effects in our case, did not lead to treatment discontinuation. The findings support the growing evidence of edaravone's safety in acute ischemic stroke treatment. Overall, edaravone demonstrates promise in stroke management, necessitating vigilant monitoring, especially considering individual cardiovascular health.
我们旨在评估静脉注射依达拉奉治疗菲律宾急性缺血性中风患者的安全性。该研究为IV期研究，时间跨度从2022年12月至2023年11月。主要目标是记录依达拉奉14天输注期内的副作用和严重不良事件。
该方案获得了机构审查委员会的批准，参与者提供了书面同意书。纳入标准包括年龄在18 - 70岁、发病24小时内的急性缺血性中风患者。排除标准包括年龄极端情况、妊娠、严重肝功能损害以及参与其他临床试验。依达拉奉给药14天，进行持续监测，并积极记录不良事件。
64名入组患者中，58名完成治疗，4名未完成，2名退出。大多数为男性（n = 35），中位年龄53.5岁，81.03%表现为中度中风严重程度。两名患者报告头痛，一名患者报告头晕。未记录到严重不良事件或其他不良影响。因射血分数低退出的患者，实验室检查结果正常，依达拉奉输注期间无副作用。37.93%的患者接受了溶栓治疗。
我们的研究为依达拉奉的安全性提供了见解，显示其副作用轻微，与现有文献一致。值得注意的是，未发生严重不良事件，强调了依达拉奉的耐受性。头痛和头晕是我们病例中的常见副作用，但未导致治疗中断。这些发现支持了依达拉奉在急性缺血性中风治疗中安全性证据的不断增加。总体而言，依达拉奉在中风管理中显示出前景，需要进行密切监测，尤其是考虑到个体心血管健康状况。
