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.
论著
目的 评价银杏二萜内酯葡胺注射液(DGMI)联合依达拉奉右崁对急性缺血性脑卒中(AIS)的治疗效果。方法 回顾性分析我院2021年3月—2022年6月收治的86例AIS患者,根据治疗方法不同,分为单药组和联合组,每组43例,2组均予以DGMI治疗,联合组加用依达拉奉右崁醇。对比2组的治疗效果。结果 治疗后,联合组美国国立卫生研究院卒中量表(NIHSS)评分低于单药组(P<0.05),简易智能精神状态检查量表(MMSE)和Barthel指数(BI)得分高于单药组(P<0.05);联合组治疗后脑血流动力学指标(Qmin和Vmin)高于单药组(P<0.05),而全血还原黏度、血浆黏度和血小板聚集指数低于单药组(P<0.05);联合组治疗后血清丙二醛(MDA)、超敏C-反应蛋白(hsCRP)和白细胞介素-6(IL-6)低于单药组(P<0.05),而超氧化物歧化酶(SOD)高于单药组(P<0.05);联合组治疗总有效率88.37%,高于单药组的67.44%(P<0.05),且2组不良反应总发生率比较差异无统计学意义(P>0.05)。结论 DGMI联合依达拉奉右崁醇可有效提高AIS患者的神经功能、认知功能及日常生活能力,降低血液高凝状态,改善脑部血流,缓解机体氧化应激及炎症反应,且不良反应发生率较低,安全性良好。
Objective To evaluate the clinical efficacy of diterpene ginkgolides meglumine injection(DGMI)combined with edaravone dextracanthol in the treatment of acute ischemic stroke(AIS).Methods A total of 86 patients with AIS admitted to our hospital from March 2021 to June 2022 were divided into single drug group and combination group according to different treatment methods,with 43 patients in each group.Both groups were treated with DGMI,and the combination group was added with edaravone dextracanthol.The therapeutic effect,neurological function and adverse reactions of the two groups were compared.Results After treatment,compared with the single drug group,the NIH Stroke Scale(NIHSS)score of the combination group was significantly lower(P<0.05),and the Mini-Mental State Examination(MMSE)and Barthel index(BI)scores were significantly higher(P<0.05).After treatment,the cerebral hemodynamic indexes(Qmin and Vmin)in the combination group were significantly higher(P<0.05),while the whole blood reducing viscosity,plasma viscosity and platelet aggregation index were significantly lower(P<0.05).After treatment,compared with the single drug group,the serum malondialdehyde(MDA),high sensitive C-reactive protein(hsCRP)and interleukin- 6(IL-6)levels in the combination group were significantly lower(P<0.05),while the level of superoxide dismutase(SOD)was significantly higher(P<0.05).The total effective rate of the combination group was 88.37%,which was significantly higher than 67.44% of the single drug group(P<0.05).The incidence of adverse reaction between two groups was not significant(P>0.05).Conclusions DGMI combined with edaravone dextracanthol can effectively improve the neurological function,cognitive function and daily living ability of patients with AIS,reduce blood hypercoagulability,improve cerebral blood flow,alleviate oxidative stress and inflammatory reaction,improve the therapeutic effect,without increasing the incidence of adverse reactions,which has good safety.
临床诊疗
目的 对于急性脑梗死患者联用依达拉奉、阿加曲班注射液治疗的临床效果进行观察。方法 运用随机、开放以及对照原则,将发病12~48 h内的80位急性脑梗死患者,随机分为40例对照组、40例联合组,2组都以对症治疗以及常规治疗为基础,在此之上,对照组以依达拉奉进行治疗,联合组以依达拉奉辅以阿加曲班进行治疗,将2组最终治疗疗效作比较,对2组患者治疗前后血清hs-CRP、凝血功能状况、日常活动能力、血流变指标以及NIHSS评分的动态变化进行实时观察。结果 就总有效率而言,对照组的72.5%显著低于联合组的92.5%,P<0.05。经治疗,2组患者凝血功能指标、血清hs-CRP、血流变指标以及NIHSS评分均有所下降,联合组较之对照组降幅更为显著(P<0.05),较之2组治疗前后,差异无统计学意义(P>0.05)。2组都不曾有不良反应出现。结论 应用依达拉奉辅以阿加曲班进行治疗急性脑梗死患者,可显著提升临床疗效,促进患者神经功能及日常活动能力恢复,减少炎症反应发生,改善预后,且无明显不良反应。