替罗非班联合小剂量 rt-PA 治疗急性非心源性脑梗死的安全性及有效性：一项单中心随机对照研究。
Safety and efficacy of low-dose rt-PA with tirofiban to treat acute non-cardiogenic stroke: a single-center randomized controlled study.
机构信息
Department of Neurology, Yantai Yuhuangding Hospital Affiliated to Qingdao University, 264000, Yantai, China.
Present Address: Yantai Yuhuangding Hostipal Affiliated to Qingdao University, No. 20 Yuhuangding East Road, Zhifu District, Shandong Province, Yantai, China.
出版信息
BMC Neurol. 2022 Jul 27;22(1):280. doi: 10.1186/s12883-022-02808-w.
BACKGROUND AND PURPOSE
The recanalization rate after intravenous thrombolysis (IVT) is not enough and there is still the possibility of re-occlusion. We aim to investigate the effectiveness and safety of infusing tirofiban after IVT.
METHODS
We performed a prospective controlled study of 60 patients with acute non-cardiogenic ischemic stroke who were hospitalized in Yantai Yuhuangding Hospital from January 2018 to December 2019. The patients were divided into 2 groups: those who received tirofiban for 24 h after IVT (rt-PA + T group) and those who did not receive postprocedural intravenous tirofiban (rt-PA group). The rt-PA + T group received low-dose rt-PA (0.6 mg/kg). The rt-PA group received standard dose rt-PA (0.9 mg/kg). The main outcome measure were safety, included the symptomatic intracranial hemorrhage (sICH), any ICH, severe systemic bleeding, and mortality. The secondary outcome measure is curative efficacy which were evaluated by the 7d-NIHSS score and functional outcomes at 90 days. During hospitalization, the deterioration of neurological function was recorded.
RESULTS
All patients completed the follow-up with complete data, there were 30 patients in each of groups. The general characteristics between the two group patients had no statistically significant differences. Compared with the rt-PA + T group and the rt-PA group, in terms of safety, the rates of the sICH, severe systemic bleeding, and mortality in both groups were 0, and there was no statistically significant difference in the rates of any ICH between the two groups (10.0% vs. 3.3%, P = 0.306). In terms of efficacy, the rate of the early neurological deterioration events (END) was no statistical significance (0 vs. 6.6%, P = 0.246). There was no significant difference in the NIHSS score between the two groups before the IVT, and also at 24 h, however, the 7d-NIHSS score was lower in the rt-PA + T group compared with the rt-PA group (2.33 ± 1.85 vs. 4.80 ± 4.02, P = 0.004). At 90 days, 83.3% of patients in the rt-PA + T group had favorable functional outcomes compared with 60.0% of patients in the rt-PA group (P = 0.045).
CONCLUSIONS
Low-dose rt-PA combined with tirofiban in acute non-cardiogenic ischemic stroke did not increase the risk of ICH, and mortality, and it was associated with neurological improvement.
TRIAL REGISTRATION
The trial has been registered at the ChiCTR and identified as ChiCTR1800014666 (28/01/2018).
背景与目的
静脉溶栓（IVT）后的再通率仍然不够，仍有再闭塞的可能。我们旨在研究替罗非班输注后的有效性和安全性。
方法
我们对 2018 年 1 月至 2019 年 12 月期间在烟台毓璜顶医院住院的 60 名急性非心源性缺血性脑卒中患者进行了前瞻性对照研究。患者分为 2 组：接受 IVT 后 24 小时内给予替罗非班的（rt-PA+T 组）和未接受术后静脉替罗非班的（rt-PA 组）。rt-PA+T 组给予低剂量 rt-PA（0.6mg/kg）。rt-PA 组给予标准剂量 rt-PA（0.9mg/kg）。主要观察指标为安全性，包括症状性颅内出血（sICH）、任何 ICH、严重全身性出血和死亡率。次要结局指标为治疗效果，由第 7 天 NIHSS 评分和 90 天的功能结局评估。住院期间记录神经功能恶化情况。
结果
所有患者均完成了随访，数据完整，每组各 30 例。两组患者的一般特征无统计学差异。与 rt-PA+T 组和 rt-PA 组相比，在安全性方面，两组 sICH、严重全身性出血和死亡率的发生率均为 0，两组任何 ICH 的发生率无统计学差异（10.0%比 3.3%，P=0.306）。在疗效方面，早期神经功能恶化事件（END）的发生率无统计学意义（0 比 6.6%，P=0.246）。两组患者 IVT 前 NIHSS 评分无统计学差异，24 小时 NIHSS 评分也无统计学差异，但 rt-PA+T 组 7 天 NIHSS 评分低于 rt-PA 组（2.33±1.85 比 4.80±4.02，P=0.004）。90 天时，rt-PA+T 组 83.3%的患者功能结局良好，rt-PA 组 60.0%的患者功能结局良好（P=0.045）。
结论
急性非心源性缺血性脑卒中患者低剂量 rt-PA 联合替罗非班不会增加 ICH 和死亡率的风险，并且与神经功能改善相关。
试验注册
该试验已在中国临床试验注册中心注册，编号 ChiCTR1800014666（28/01/2018）。
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