Gao Haobo, Tan Hongtu, Wang Jiabin, Yang Dongyi, Liu Yangyang, Wu Tao
Department of Intervention, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.
Front Neurol. 2025 Aug 28;16:1589307. doi: 10.3389/fneur.2025.1589307. eCollection 2025.
In China, edaravone dexborneol (ED) is often used to treat acute ischemic stroke (AIS), but internationally, ED is not commonly used. This study aimed to conduct a meta-analysis on the application of ED in AIS, so as to provide reference and guidance for clinical use in the future.
Pubmed and Web of Science databases were searched for articles on ED in the treatment of AIS. Two researchers independently searched the articles based on pre-specified inclusion (randomized controlled trial, complete data, correct logic, English literature, etc.) and exclusion criteria (studies lacking objective reference standards, studies with follow-up success rates below 80%, etc.), and duplicate articles were excluded using Endnote. The search was set for the build time to December 2024. Then, the initially enrolled articles were subjected to information and data extraction and crosschecking, followed by meta analysis using the RevMan 5.3 software after screening. Primary outcome measures included clinical efficacy, safety, and NIHSS.
A total of 5 articles were included after screening, totaling 2,651 study participants. Subjects in the 5 articles were divided into an experimental group (ED treatment, = 1,465) and a control group (other treatment regimen(s), = 1,226). All the articles were of high quality and high reference value. According to Meta-analysis, no statistically significant difference was observed in the incidence of adverse reactions between the ED and control groups (95%CI = 0.67 ~ 1.04, = 0.11), but the clinical efficacy in the experimental group exhibited significantly better outcomes compared to the control group (95%CI = 0.03 ~ 0.09, = 0.0002). In addition, NIHSS (95%CI = -4.67 ~ -0.13, = 0.04) and hs-CRP (95%CI = -1.90 ~ -0.23, = 0.01) were lower in the experimental group than in the control group. Funnel plots were drawn for outcome measures with heterogeneity. The results showed that the funnel plot of the NIHSS scores and hs-CRP were basically symmetrical.
While ED demonstrates short-term efficacy in improving neurological outcomes, its clinical applicability remains uncertain due to unresolved questions about drug diffusion and delivery in human brain tissue, which may fundamentally limit its long-term benefits.
在中国，依达拉奉右莰醇（ED）常用于治疗急性缺血性卒中（AIS），但在国际上，ED并不常用。本研究旨在对ED在AIS中的应用进行荟萃分析，以便为未来的临床应用提供参考和指导。
在Pubmed和Web of Science数据库中检索关于ED治疗AIS的文章。两名研究人员根据预先设定的纳入标准（随机对照试验、完整数据、逻辑正确、英文文献等）和排除标准（缺乏客观参考标准的研究、随访成功率低于80%的研究等）独立检索文章，并使用Endnote排除重复文章。检索设定的建库时间截至2024年12月。然后，对最初纳入的文章进行信息和数据提取及交叉核对，筛选后使用RevMan 5.3软件进行荟萃分析。主要结局指标包括临床疗效、安全性和美国国立卫生研究院卒中量表（NIHSS）。
筛选后共纳入5篇文章，研究参与者总计2651名。这5篇文章中的受试者分为实验组（ED治疗，=1465）和对照组（其他治疗方案，=1226）。所有文章质量高，具有较高参考价值。根据荟萃分析，ED组和对照组之间不良反应发生率无统计学显著差异（95%CI = 0.67 ~ 1.04，= 0.11），但实验组的临床疗效明显优于对照组（95%CI = 0.03 ~ 0.09，= 0.0002）。此外，实验组的NIHSS（95%CI = -4.67 ~ -0.13，= 0.04）和超敏C反应蛋白（hs-CRP）（95%CI = -1.90 ~ -0.23，= 0.01）低于对照组。对存在异质性的结局指标绘制漏斗图。结果显示，NIHSS评分和hs-CRP的漏斗图基本对称。
虽然ED在改善神经功能结局方面显示出短期疗效，但其临床适用性仍不确定，因为关于药物在人脑组织中的扩散和递送问题尚未解决，这可能从根本上限制其长期益处。
