{"title":"Efficacy and safety of edaravone dexborneol in acute ischemic stroke: systematic review and meta-analysis of randomized controlled trials.","authors":"Muataz Kashbour, Abdelrahman Shata, Mohamed Wagdy, Asmaa Zakria Alnajjar, Mohamed A Aldemerdash, Husam Tarakhan, Moaz Elsayed Abouelmagd","doi":"10.1007/s00210-025-03950-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Stroke is a leading cause of global morbidity and mortality, with acute ischemic stroke (AIS) accounting for most cases. Despite advancements in reperfusion therapies, many patients do not achieve sufficient reperfusion, necessitating effective neuroprotective interventions. This meta-analysis evaluates the efficacy and safety of Edaravone Dexborneol (ED) compared to standard therapies in AIS treatment.</p><p><strong>Methods: </strong>A systematic review and meta-analysis were conducted according to PRISMA guidelines, including randomized controlled trials (RCTs) investigating ED in AIS. Primary outcomes included Modified Rankin Scale (mRS ≤ 1) at 90 days and changes in National Institutes of Health Stroke Scale (NIHSS) scores. Pooled effect sizes were calculated using random-effects models.</p><p><strong>Results: </strong>Five RCTs with 2,535 patients (1,263 ED, 1,272 control) were included. ED significantly improved the odds of achieving mRS ≤ 1 at 90 days (OR = 1.47, 95% CI [1.25-1.74], p < 0.00001). While NIHSS score changes at 14 days were not significant (p = 0.35), ED showed significant improvement at 30 days (MD = -1.77, 95% CI [-2.82 to -0.72], p = 0.0009). ED also significantly reduced the risk of hemorrhagic transformation (OR = 0.47, 95% CI [0.24-0.92], p = 0.03) and mortality rates were lower in the ED group but not statistically significant (OR = 0.66, 95% CI [0.41-1.06], p = 0.08, I<sup>2</sup> = 1%).</p><p><strong>Conclusion: </strong>ED demonstrates significant neuroprotective benefits in AIS by improving functional outcomes and reducing the risk of hemorrhagic transformation. However, further studies with larger sample sizes must confirm these findings and optimize treatment protocols.</p>","PeriodicalId":18876,"journal":{"name":"Naunyn-Schmiedeberg's archives of pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Naunyn-Schmiedeberg's archives of pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00210-025-03950-1","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Stroke is a leading cause of global morbidity and mortality, with acute ischemic stroke (AIS) accounting for most cases. Despite advancements in reperfusion therapies, many patients do not achieve sufficient reperfusion, necessitating effective neuroprotective interventions. This meta-analysis evaluates the efficacy and safety of Edaravone Dexborneol (ED) compared to standard therapies in AIS treatment.
Methods: A systematic review and meta-analysis were conducted according to PRISMA guidelines, including randomized controlled trials (RCTs) investigating ED in AIS. Primary outcomes included Modified Rankin Scale (mRS ≤ 1) at 90 days and changes in National Institutes of Health Stroke Scale (NIHSS) scores. Pooled effect sizes were calculated using random-effects models.
Results: Five RCTs with 2,535 patients (1,263 ED, 1,272 control) were included. ED significantly improved the odds of achieving mRS ≤ 1 at 90 days (OR = 1.47, 95% CI [1.25-1.74], p < 0.00001). While NIHSS score changes at 14 days were not significant (p = 0.35), ED showed significant improvement at 30 days (MD = -1.77, 95% CI [-2.82 to -0.72], p = 0.0009). ED also significantly reduced the risk of hemorrhagic transformation (OR = 0.47, 95% CI [0.24-0.92], p = 0.03) and mortality rates were lower in the ED group but not statistically significant (OR = 0.66, 95% CI [0.41-1.06], p = 0.08, I2 = 1%).
Conclusion: ED demonstrates significant neuroprotective benefits in AIS by improving functional outcomes and reducing the risk of hemorrhagic transformation. However, further studies with larger sample sizes must confirm these findings and optimize treatment protocols.
期刊介绍：
Naunyn-Schmiedeberg''s Archives of Pharmacology was founded in 1873 by B. Naunyn, O. Schmiedeberg and E. Klebs as Archiv für experimentelle Pathologie und Pharmakologie, is the offical journal of the German Society of Experimental and Clinical Pharmacology and Toxicology (Deutsche Gesellschaft für experimentelle und klinische Pharmakologie und Toxikologie, DGPT) and the Sphingolipid Club. The journal publishes invited reviews, original articles, short communications and meeting reports and appears monthly. Naunyn-Schmiedeberg''s Archives of Pharmacology welcomes manuscripts for consideration of publication that report new and significant information on drug action and toxicity of chemical compounds. Thus, its scope covers all fields of experimental and clinical pharmacology as well as toxicology and includes studies in the fields of neuropharmacology and cardiovascular pharmacology as well as those describing drug actions at the cellular, biochemical and molecular levels. Moreover, submission of clinical trials with healthy volunteers or patients is encouraged. Short communications provide a means for rapid publication of significant findings of current interest that represent a conceptual advance in the field.
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