目的：描述发病48 h内急性缺血性卒中（acute ischemic stroke，AIS）患者依达拉奉右莰醇真实世界用药特征，探讨48 h内不同启动时间与住院期间神经功能改善及短期预后的关系。方法：回顾性连续筛选2023年12月1日至2026年4月30日本院诊断为AIS并使用依达拉奉右莰醇的住院患者，药学部基于药学信息系统、住院医嘱及病历记录提取资料。初筛147例，排除35例，纳入112例发病至首次用药时间（onset-to-treatment time，OTT）≤48 h者；按预设24 h界值分为24 h内用药组（n=67）和24～48 h用药组（n=45）。主要结局为住院期间美国国立卫生研究院卒中量表（National Institutes of Health Stroke Scale，NIHSS）变化值（ΔNIHSS=入院NIHSS评分－出院前NIHSS评分）；次要结局包括出院前NIHSS评分、出院改良Rankin量表（modified Rankin Scale，mRS）评分、显著神经功能改善、住院时间、出院去向及安全性事件。采用多因素线性回归分析24 h内用药与ΔNIHSS的相关性，并行简化模型、排除再灌注治疗患者、完整疗程人群、进一步调整大血管闭塞及OTT连续变量模型等敏感性分析。结果：总体OTT为19.65（14.97，34.68）h，疗程12.00（11.00，13.00）d，完成相对完整疗程比例89.3%。两组入院NIHSS评分差异无统计学意义［8.00（6.00，9.00）分 vs 8.00（6.00，10.00）分，P=0.447］；24 h内用药组出院前NIHSS评分更低［5.00（4.00，6.50）分 vs 6.00（5.00，8.00）分，P=0.025］，ΔNIHSS更高［3.00（2.00，3.00）分 vs 2.00（1.00，2.00）分，P＜0.001］，显著神经功能改善率更高（77.6% vs 60.0%，P=0.045）。多因素校正后，24 h内用药仍与更大的ΔNIHSS相关（β=0.768，95%CI：0.377～1.159，P＜0.001）；Logistic探索性分析显示其与显著神经功能改善发生可能性较高相关（OR=2.475，95%CI：1.047～5.853，P=0.039）。两组出血转化、症状性颅内出血、药物相关不良反应及院内死亡差异均无统计学意义。结论：本单中心真实世界队列中，发病48 h内依达拉奉右莰醇治疗疗程完成比例较高、短期安全性事件发生率低；24 h内启动治疗与住院期间NIHSS改善幅度较大及显著神经功能改善率较高相关。由于为回顾性观察性研究，结果应解释为关联性证据，需前瞻性、多中心研究及长期功能结局验证。
Objective: To describe real-world treatment characteristics of edaravone dexborneol in acute ischemic stroke (AIS) patients treated within 48 hours of onset and to explore the association between initiation time and short-term in-hospital outcomes. Methods: This single-center retrospective real-world study screened hospitalized AIS patients with edaravone dexborneol records from December 1, 2023 to April 30, 2026. Medication data were extracted from the pharmacy information system, inpatient orders, and medical records. After 35 exclusions, 112 of 147 patients with onset-to-treatment time (OTT) ≤48 h were included and classified by a prespecified 24-hour cutoff into a within-24-hour group (n=67) and a 24-48-hour group (n=45). The primary outcome was in-hospital National Institutes of Health Stroke Scale (NIHSS) change (ΔNIHSS=admission NIHSS minus pre-discharge NIHSS); secondary outcomes included pre-discharge NIHSS, discharge modified Rankin Scale (mRS), marked neurological improvement, length of stay, discharge destination, and safety events. Multivariable linear regression assessed the association between within-24-hour treatment and ΔNIHSS, with sensitivity analyses using simplified adjustment, exclusion of reperfusion-treated patients, the complete-course population, additional adjustment for large-vessel occlusion, and continuous OTT modeling. Results: Median OTT was 19.65 (14.97, 34.68) h, treatment duration was 12.00 (11.00, 13.00) days, and 89.3% completed a relatively complete course. Baseline NIHSS was comparable [8.00 (6.00, 9.00) vs 8.00 (6.00, 10.00), P=0.447]. The within-24-hour group had lower pre-discharge NIHSS [5.00 (4.00, 6.50) vs 6.00 (5.00, 8.00), P=0.025], greater ΔNIHSS [3.00 (2.00, 3.00) vs 2.00 (1.00, 2.00), P<0.001], and a higher marked improvement rate (77.6% vs 60.0%, P=0.045). After adjustment for age, admission NIHSS, reperfusion therapy, and atrial fibrillation, within-24-hour treatment remained associated with greater ΔNIHSS (β=0.768, 95% CI: 0.377-1.159, P<0.001). Exploratory logistic regression showed a higher likelihood of marked improvement (OR=2.475, 95% CI: 1.047-5.853, P=0.039). Hemorrhagic transformation, symptomatic intracranial hemorrhage, drug-related adverse reactions, and in-hospital death did not differ significantly. Conclusion: In this real-world cohort, edaravone dexborneol within 48 h of AIS onset showed a high complete-course proportion and low short-term safety event incidence. Initiation within 24 h was associated with greater in-hospital NIHSS improvement and a higher marked improvement rate than initiation at 24-48 h. These findings are associative and need prospective multicenter validation with long-term functional outcomes.
