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替罗非班用于静脉溶栓后进展性卒中的前瞻性试点研究。

Prospective pilot study of tirofiban in progressive stroke after intravenous thrombolysis.

作者信息

Zhang Yan, Wang Jianliang, Ma Zhaoxi, Mu Guihua, Liang Da, Li Yifan, Qian Xiaoyan, Zhang Luyuan, Shen Fang, Zhang Lei, Yu Jie, Liu Yang

机构信息

Department of Neurology, The Kunshan Affiliated Hospital of Jiangsu University, The First People's Hospital of Kunshan, Kunshan, China.

Department of Radiology, The Kunshan Affiliated Hospital of Jiangsu University, The First People's Hospital of Kunshan, Kunshan, China.

出版信息

Front Neurol. 2022 Oct 4;13:982684. doi: 10.3389/fneur.2022.982684. eCollection 2022.

Abstract

BACKGROUND

Intravenous thrombolysis (IVT) is a standard procedure for the treatment of patients with acute ischemic stroke (AIS). Improving the therapeutic efficacy of IVT is an important task for neurologists. The aim of this study was to evaluate the efficacy and safety of early low-dose tirofiban treatment in AIS patients with early neurological deterioration (END) after IVT.

METHODS

In this prospective and randomized pilot study, 73 AIS patients with END were recruited from a local hospital in China. Of these, 14 patients were treated with regular antiplatelet agents (aspirin plus clopidogrel) and 59 patients were treated with tirofiban within 24 h of IVT, followed by regular antiplatelet therapy. Neurological deficits and functional recovery were assessed with NIHSS and modified Rankin Scale (mRS) at 7 and 90 days. During the 90-day follow-up period, both hemorrhagic (e.g., intracerebral hemorrhage) and non-hemorrhagic (e.g., pneumonia) events were recorded.

RESULTS

Treatment with tirofiban compared with regular antiplatelet therapy: (1) improved functional recovery of AIS patients to mRS (≤2) at both 7 and 90 days (odds ratios [ORs], 1.37 and 1.64; 95% confidence interval [CI], 1.16-1.61 and 1.26-2.12; = 0.008 and < 0.001, respectively), and (2) reduced NIHSS scores from 11.14 ± 2.38 to 5.95 ± 3.48 at day 7 ( < 0.001) and from 8.14 ± 2.74 to 4.08 ± 3.50 at day 90 ( < 0.001). Tirofiban treatment did not increase the risk of hemorrhagic complications. Multivariate regression analysis showed that tirofiban treatment independently predicted a favorable functional outcome ( ≤ 0.001).

CONCLUSION

Early treatment with low-dose tirofiban in AIS patients with neurologic deterioration after IVT potentially improved functional recovery and attenuated neurologic deficits as early as 7 days and did not increase the risk of various hemorrhagic complications. However, the therapeutic efficacy of tirofiban treatment in END patients needs to be determined by future randomized clinical trials with a large study population.

CLINICAL TRIAL REGISTRATION

http://www.chictr.org.cn/, Identifier ChiCTR2200058513.

摘要

背景

静脉溶栓(IVT)是治疗急性缺血性卒中(AIS)患者的标准程序。提高IVT的治疗效果是神经科医生的一项重要任务。本研究的目的是评估早期低剂量替罗非班治疗对IVT后出现早期神经功能恶化(END)的AIS患者的疗效和安全性。

方法

在这项前瞻性随机对照试验中,从中国一家当地医院招募了73例END的AIS患者。其中,14例患者接受常规抗血小板药物(阿司匹林加氯吡格雷)治疗,59例患者在IVT后24小时内接受替罗非班治疗,随后进行常规抗血小板治疗。在第7天和第90天用美国国立卫生研究院卒中量表(NIHSS)和改良Rankin量表(mRS)评估神经功能缺损和功能恢复情况。在90天的随访期内,记录出血性(如脑出血)和非出血性(如肺炎)事件。

结果

与常规抗血小板治疗相比,替罗非班治疗:(1)在第7天和第90天均改善了AIS患者至mRS(≤2)的功能恢复情况(优势比[OR]分别为1.37和1.64;95%置信区间[CI]为1.16 - 1.61和1.26 - 2.12;P分别为0.008和<0.001),且(2)在第7天将NIHSS评分从11.14±2.38降至5.95±3.48(P<0.001),在第90天将NIHSS评分从8.14±2.74降至4.08±3.50(P<0.001)。替罗非班治疗未增加出血并发症的风险。多因素回归分析表明,替罗非班治疗可独立预测良好的功能结局(P≤0.001)。

结论

IVT后神经功能恶化的AIS患者早期使用低剂量替罗非班治疗可能改善功能恢复,并早在7天就减轻神经功能缺损,且不增加各种出血并发症的风险。然而,替罗非班治疗对END患者的疗效需要未来更大样本量的随机临床试验来确定。

临床试验注册

http://www.chictr.org.cn/,标识符ChiCTR2200058513。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dcd1/9577296/c8fb4e2844df/fneur-13-982684-g0001.jpg

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