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替罗非班注射液治疗超标准时间窗急性缺血性卒中的安全性及有效性评估

Evaluation of safety and efficacy of Tirofiban injection for treating acute ischemic stroke beyond standard time window.

作者信息

Yang Qian, He Qiaofeng, Mao Xinfa, Fan Weibing, Luo Xin

机构信息

Department of Neurology, The Third Hospital of Changsha, Changsha, Hunan, China.

出版信息

Sci Rep. 2025 Jul 28;15(1):27399. doi: 10.1038/s41598-025-11882-2.

Abstract

To evaluate the safety and efficacy of tirofiban in the treatment of acute ischemic stroke (AIS). Clinical data of 152 AIS patients with small vessel occlusion admitted in 2023 were retrospectively analyzed. These patients did not receive intravenous thrombolysis and endovascular treatment within 72 h of onset. Patients were divided into two groups (n = 76 each group): a dual antiplatelet group (aspirin + clopidogrel for 14 days, followed by aspirin alone) and a tirofiban group (dual antiplatelet therapy plus tirofiban). Neurological deficits and functional outcomes were assessed before treatment, on day 7, and day 90. Serum hs-CRP and IL-6 levels were measured prior to treatment and on day 7. Symptom aggravation, symptomatic bleeding, and mortality within 90 days were also recorded. Baseline characteristics of the two groups were comparable. Tirofiban treatment significantly improved mRS scores from baseline to day 7 (t = 5.94, p < 0.001) and day 90 (t = 5.67, p < 0.001) (F = 53.13, p < 0.001), with improvements persisting after adjusting for baseline scores (F = 32.56, p < 0.001). Moreover, tirofiban treatment significantly reduced NIHSS scores at days 7 (mean difference = - 0.97 (95% CI: - 1.53, - 0.41); t = 3.57, p < 0.001) and 90 (mean difference = - 0.82 (95% CI: - 1.29, - 0.34); t = 3.97, p < 0.001) and increased Barthel Index scores at days 7 (mean difference = 9.8 (95% CI: 4.3, 15.3); t = - 3.14, p = 0.002) and 90 (mean difference = 11.7 (95% CI: 6.2, 17.2); t = - 4.41, p < 0.001), indicating greater functional independence. No significant differences were observed between the two groups in inflammatory markers (hs-CRP and IL-6), intracranial hemorrhage, or mortality. However, there was a trend toward a higher rate of deterioration in the dual antiplatelet group (13.4% vs. 5.6%). Tirofiban combined with conventional treatment significantly improves neurological deficits and disease outcomes in AIS patients without increasing the risk of bleeding and mortality.

摘要

评估替罗非班治疗急性缺血性卒中(AIS)的安全性和有效性。回顾性分析了2023年收治的152例小血管闭塞性AIS患者的临床资料。这些患者在发病72小时内未接受静脉溶栓和血管内治疗。患者分为两组(每组n = 76):双联抗血小板组(阿司匹林 + 氯吡格雷治疗14天,随后单独使用阿司匹林)和替罗非班组(双联抗血小板治疗加替罗非班)。在治疗前、第7天和第90天评估神经功能缺损和功能结局。在治疗前和第7天测量血清hs-CRP和IL-6水平。还记录了90天内的症状加重、症状性出血和死亡率。两组的基线特征具有可比性。替罗非班治疗从基线到第7天(t = 5.94,p < 0.001)和第90天(t = 5.67,p < 0.001)显著改善了mRS评分(F = 53.13,p < 0.001),在调整基线评分后改善仍持续存在(F = 32.56,p < 0.001)。此外,替罗非班治疗在第7天(平均差值 = - 0.97(95%CI:- 1.53,- 0.41);t = 3.57,p < 0.001)和第90天(平均差值 = - 0.82(95%CI:- 1.29,- 0.34);t = 3.97,p < 0.001)显著降低了NIHSS评分,并在第7天(平均差值 = 9.8(95%CI:4.3,15.3);t = - 3.14,p = 0.002)和第90天(平均差值 = 11.7(95%CI:6.2,17.2);t = - 4.41,p < 0.001)提高了Barthel指数评分,表明功能独立性更强。两组在炎症标志物(hs-CRP和IL-6)、颅内出血或死亡率方面未观察到显著差异。然而,双联抗血小板组有更高恶化率的趋势(13.4%对5.6%)。替罗非班联合传统治疗可显著改善AIS患者的神经功能缺损和疾病结局,且不增加出血和死亡风险。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb34/12304154/5df9aa38dd52/41598_2025_11882_Fig1_HTML.jpg

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