Efficacy of Dual Antiplatelet Therapy after Intravenous Thrombolysis in Patients with Mild Ischemic Stroke

doi:10.3969/j.issn.1673-5765.2021.10.012

Abstract

Abstract:

Objective To observe the efficacy and safety of rt-PA intravenous thrombolysis combined with dual antiplatelet therapy in patients with mild ischemic stroke.

Methods Patients with mild ischemic stroke who were admitted in Department of Neurology, the First Hospital of Shijiazhuang from December 2013 to December 2016 were prospectively enrolled in this study, and all subjects were randomly divided into three groups: control group, thrombolysis + mono antiplatelet therapy group (observation group A), and thrombolysis + dual antiplatelet therapy group (observation group B). The control group didn’t receive intravenous thrombolysis and were given long-term oral aspirin (100 mg/d), the observation group A was given long-term aspirin therapy (100 mg/d) after rt-PA intravenous thrombolysis (0.9 mg/kg, the maximum dose of 90 mg). The observation group B was given clopidogrel (75 mg/d) and aspirin (100 mg/d) for 21 days after intravenous thrombolysis, and then dual antiplatelet therapy was changed to long-term mono aspirin therapy. The follow-up time was 3 months. The efficacy indexes included the proportion of NIHSS score 0-1, Barthel index (BI) score 95-100, mRS score 0-1 at 3 months. The safety indexes included the incidence of 24-hour hemorrhagic transformation and symptomatic hemorrhagic transformation. In addition, the levels of serum hs-CRP and IL-6 at the baseline and 3 months were compared in the three groups.

Results A total of 85 patients were included in the study, including 28 cases in control group, 28 in observation group A and 29 in observation group B. All patients were followed up for 3 months and there was no death. The proportion of NIHSS score 0-1 in control group, observation group A and B were 46.43%, 78.57% and 93.10%, respectively, and that of BI score 95-100 for 53.57%, 82.14% and 89.66%, respectively, and that of mRS score 0-1 for 50.00%, 82.14% and 93.10%, respectively, and all the above differences among the three groups were statistically significant. The pairwise comparison of the above indexes showed that that of the observation group B was higher than that of observation group A and control group, and that of observation group A was higher than that of control group, and the differences were statistically significant. The incidence of recurrent ischemic stroke in the control group, observation group A and B were 32.14%, 7.14% and 3.45%, respectively, and the difference was statistically significant. There was no hemorrhagic transformation event in the three groups. In addition, the level of hs-CRP in the control group, observation group A and B were 11.92±3.58 mg/L, 9.04±2.85 mg/L and 6.04±2.65 mg/L, respectively, and the level of IL-6 for 26.18±4.65 ng/L, 16.11±6.93 ng/L and 12.84±2.57 ng/L, respectively, and the above differences in inflammatory factors among the three groups were statistically significant, and the pairwise comparison showed that that of observation group B was lower than that of observation group A and control group, and that of observation group A was lower than that of control group.

Conclusions For patients with mild ischemic stroke, short-term dual antiplatelet therapy after intravenous thrombolysis with rt-PA can significantly improve neurological function, reduce the levels of inflammatory factors and stroke recurrence, without increasing the risk of bleeding.

Key words: Ischemic stroke; Mild stroke; Thrombolysis; Antiplatelet; Aspirin; Clopidogrel;Neurological function; Hemorrhagic transformation

摘要：

目的观察rt-PA静脉溶栓联合双重抗血小板治疗轻型缺血性卒中的有效性及安全性。

方法以2013年12月-2016年12月在石家庄市第一医院连续住院治疗的轻型缺血性卒中患者为研究对象，将其随机分为对照组、溶栓+单抗组和溶栓+双抗组。对照组不进行静脉溶栓，长期口服阿司匹林（100 mg/d）抗血小板治疗；溶栓+单抗组在rt-PA静脉溶栓（0.9 mg/kg，最大剂量90 mg）基础上长期单用阿司匹林（100 mg/d）抗血小板治疗；溶栓+双抗组在溶栓后单抗基础上加用氯吡格雷（75 mg/d）双重抗血小板治疗，双抗治疗21 d后改为阿司匹林长期单抗治疗。随访3个月，有效性指标为3个月时NIHSS 0～1分、Barthel指数（Barthel index，BI）95～100分和mRS 0～1分的比例，3个月时缺血性卒中的复发率；安全性指标为治疗24 h出血转化和症状性出血转化的发生率。另外比较三组间基线和3个月时血清hs-CRP和IL-6的水平差异。

结果研究共纳入85例患者，对照组28例，溶栓+单抗组28例，溶栓+双抗组29例，全部患者均完成3个月随访，无死亡患者。对照组、溶栓+单抗组和溶栓+双抗组3个月随访时NIHSS 0～1分比例分别为46.43%、78.57%和93.10%，BI 95～100分比例分别为53.57%、82.14%和89.66%，mRS 0～1分的比例分别为50.00%、82.14%和93.10%，三组上述有效性指标差异均有统计学意义，两两比较显示，溶栓+双抗组高于溶栓+单抗组和对照组，溶栓+单抗组高于对照组，差异均有统计学意义；对照组、溶栓+单抗组和溶栓+双抗组3个月时缺血性卒中复发率分别为32.14%、7.14%和3.45%，差异有统计学意义。安全性指标方面，三组均无出血转化事件。对照组、溶栓+单抗组和溶栓+双抗组3 个月时的hs-CRP水平分别为11.92±3.58 mg/L、9.04±2.85 mg/L和6.04±2.65 mg/L，IL-6水平分别为 26.18±4.65 ng/L、16.11±6.93 ng/L和12.84±2.57 ng/L，三组上述炎症因子水平差异均有统计学意义，其中溶栓+双抗组低于溶栓+单抗组和对照组，溶栓+单抗组低于对照组。

结论对于急性轻型缺血性卒中患者，rt-PA静脉溶栓治疗后短期双重抗血小板治疗可显著改善患者神经功能，降低炎症因子水平，降低复发率，且不增加出血风险。

关键词: 缺血性卒中; 轻型卒中; 溶栓; 抗血小板; 阿司匹林; 氯吡格雷; 神经功能; 出血转化

WANG Cong-Jie, LI Hong, ZHENG Li, LIU Shan, LU Hai-Li, CHEN Na, ZHANG Bin, ZHOU Heng. Efficacy of Dual Antiplatelet Therapy after Intravenous Thrombolysis in Patients with Mild Ischemic Stroke[J]. Chinese Journal of Stroke, 2021, 16(10): 1044-1049.

王聪杰, 李虹, 郑丽, 刘珊, 卢海丽, 陈娜, 张斌, 周衡. 轻型缺血性卒中静脉溶栓后双重抗血小板疗效观察[J]. 中国卒中杂志, 2021, 16(10): 1044-1049.

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