替罗非班治疗MRI筛选的轻中度非心源性缺血性卒中的安全性和有效性研究

doi:10.3969/j.issn.1673-5765.2022.01.009

摘要/Abstract

摘要：

目的探讨替罗非班治疗MRI筛选的轻中度急性非心源性缺血性卒中的安全性及临床疗效。

方法前瞻性连续纳入2020年1月－2021年1月在青岛大学附属烟台毓璜顶医院住院治疗的，发病 6～72 h的，完善MRI 检查，非大动脉闭塞，未进行再灌注治疗的轻中度非心源性缺血性卒中患者60例作为研究对象。头颅MRI和MRA排除大面积脑梗死和大血管闭塞。1∶1随机分为试验组与对照组，试验组（30例）给予替罗非班连续静脉输注72 h（0.4 μg·kg－1·min－1维持30 mi n，续以0.1 μg·kg－1·min－1 泵入维持72 h），结束前4 h服用负荷量氯吡格雷（300 mg）和阿司匹林（100 mg），后续服用阿司匹林（100毫克/次，1次/日）和氯吡格雷（75毫克/次，1次/日）至21 d，然后单用阿司匹林（100毫克/次， 1次/日）或氯吡格雷（75毫克/次，1次/日）持续69 d。对照组不用替罗非班治疗，抗血小板治疗策略同试验组。其他治疗包括口服他汀药物等标准卒中二级预防治疗。主要观察指标是72 h内症状性颅内出血，次要观察指标是治疗后72 h、14 d NIHSS评分及90 d mRS评分，以mRS 0～2分为预后良好。

结果 59例患者完成了试验，其中试验组30例，对照组29例。两组患者基线资料比较差异无统计学意义。两组症状性颅内出血及死亡率均为0。试验组治疗后72 h NIHSS [5.00（3.75～7.00）分vs. 6.00 （5.00～8.00）分，P =0.042] 和14 d NIHSS [3.00（2.00～5.25）分 vs. 4.00（3.00～7.00）分，P =0.011] 均低于对照组。90 d时，试验组预后良好患者比例高于对照组（66.7% vs. 41.4%，P =0.045）。

结论替罗非班可能是轻中度非心源性缺血性卒中患者急性期一种安全有效的治疗方法，可以改善患者神经功能缺损症状及预后。

文章导读： 经影像学筛查无大动脉闭塞且超过溶栓时间窗的症状性颅内动脉粥样硬化或小动脉闭塞的穿支动脉梗死的缺血性卒中患者，急性期静脉注射替罗非班是安全且有效的，值得进一步行大样本随机对照研究验证。

关键词: 替罗非班; 非心源性卒中; 抗血小板药物; 安全性; 临床疗效

Abstract:

Objective To investigate the safety and clinical efficacy of tirofiban in the treatment of acute noncardiogenic ischemic stroke screened by MRI.

Methods This study prospectively enrolled sixty inpatients with non-cardiogenic ischemic stroke who did not receive intravenous thrombolysis and endovascular treatment and who underwent MRI scan during 6-72 hours after stroke onset in Yantai Yuhuangding Hospital Affiliated to Qingdao University from January 2020 to January 2021. The patients with massive cerebral infarction and large vessel occlusion were excluded. All the included patients were randomly assigned in a 1:1 double-blind fashion to observation and control groups. The medication regimen as follows: in observation group (n =30), intravenous tirofiban for 72 hours and overlapped with a loading dose of 100 mg aspirin and 300 mg clopidogrel in the last 4 hours, followed by 100 mg aspirin plus 75 mg clopidogrel per day for 21 days, after 21 days of dual antiplatelet treatment, the patients were administered mono-antiplatelet treatment (aspirin 100 mg or clopidogrel 75 mg per day) for the next 69 days. The control group (n =30) was not given tirofiban, and the other oral antiplatelet regimen were the same as that in observation group. The primary outcome was symptomatic intracranial hemorrhage (sICH) within 72 hours after treatment. The secondary outcome included NIHSS score at 72 hours, 14 days after treatment, and 90-day favorable prognosis. Favorable prognosis was defined as a mRS score of 0 to 2. The primary and secondary outcomes between the two groups were compared.

Results A total of 59 patients completed the trial, 30 in observation group and 29 in control group. No significant differences were found in baseline characteristics between the two groups. There was no sICH and death in both the two groups. The NIHSS scores were lower in observation group than that in control group at 72 hours [5.00 (3.75-7.00) vs . 6.00 (5.00-8.00), P =0.042] and 14 days [3.00 (2.00-5.25) vs . 4.00 (3.00-7.00), P =0.011]. The 90-day favorable prognosis rate in observation group was higher than that in control group (66.7% vs . 41.4%, P =0.045).

Conclusions Tirofiban can be a safe and effective therapy for mild and moderate acute noncardiogenic ischemic stroke, which can improve neurological function impairment and prognosis.

Key words: Tirofiban; Non-cardiogenic ischemic stroke; Antiplatelet agent; Safety; Clinical efficacy

张俊良, 黄双凤, 徐璐瑶, 向薇, 张曼曼, 梁志刚. 替罗非班治疗MRI筛选的轻中度非心源性缺血性卒中的安全性和有效性研究[J]. 中国卒中杂志, 2022, 17(01): 66-72.

ZHANG Junliang, HUANG Shuangfeng, XU Luyao, XIANG Wei, ZHANG Manman, LIANG Zhigang. Safety and Efficacy of Tirofiban in the Treatment of Mild to Moderate Non-Cardiogenic Ischemic Stroke Screened by MRI[J]. Chinese Journal of Stroke, 2022, 17(01): 66-72.

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