Efficacy of Urinary Kallidinogenase Plus Intravenous Recombinant Tissue Plasminogen Activator for Stroke Patients With Extended Window: A Retrospective Analysis.
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Abstract
Background: To assess the outcome of human urinary kallidinogenase (HUK) plus recombinant tissue plasminogen activator (rT-PA) intravenous thrombolysis for stroke patients with an extended time window(4.5 to 9 h).
Methods: A total of 92 acute ischemic stroke patients who fulfilled the criteria were included in this study. All patients received basic treatment and intravenous rT-PA, and 49 patients received additional injections of HUK (HUK group) once a day for 14 consecutive days. Outcomes were indicated by the thrombolysis in cerebral infarction score as the primary endpoint and the National Institute of Health Stroke Scale, modified Rankin Scale, and Barthel Index as the secondary endpoints. The safety outcomes were the rate of symptomatic intracranial hemorrhage, bleeding, angioedema, and mortality.
Results: The National Institute of Health Stroke Scale scores were significantly lower in the HUK group at hospital discharge (4.55 ± 3.78 vs 7.88 ± 7.31, P = 0.009) and day 90 (4.04 ± 3.51 vs 8.12 ± 9.53, P = 0.011). The improvements in the Barthel Index scores were more obvious in the HUK group. Patients in the HUK group achieved favorable functional independence (67.35% vs 46.51%; odds ratio: 2.37; 95% CI: 1.01-5.53) at 90 days. The recanalization rate of the HUK group was 64.10%, whereas that was 41.48% in the control group ( P = 0.050). The complete reperfusion rates were 42.9% and 23.3% in the HUK group and the control group, respectively. No significant differences were observed for adverse events between the two groups.
Conclusions: Combination therapy of HUK plus rT-PA in patients with acute ischemic stroke with an extended time window can safely improve their functional outcomes.
背景：评估人尿激肽原酶（HUK）联合重组组织纤溶酶原激活剂（rT-PA）静脉溶栓治疗延长时间窗（4.5至9小时）的脑卒中患者的疗效。方法：本研究共纳入92例符合标准的急性缺血性脑卒中患者。所有患者都接受了基础治疗和静脉注射rT-PA，49名患者接受了HUK（HUK组）的额外注射，每天一次，连续14天。结果以脑梗死溶栓评分为主要终点，以美国国家卫生研究所卒中量表、改良兰金量表和Barthel指数为次要终点。安全性结果是症状性颅内出血率、出血率、血管性水肿率和死亡率。结果：出院时（4.55±3.78 vs 7.88±7.31，P=0.009）和90天（4.04±3.51 vs 8.12±9.53，P=0.011），HUK组的国家健康研究所卒中量表评分显著降低。HUK组患者在90天时实现了良好的功能独立性（67.35%对46.51%；比值比：2.37；95%可信区间：1.01-5.53）。HUK组再通率为64.10%，对照组为41.48%（P=0.050），完全再灌注率分别为42.9%和23.3%。两组之间的不良事件没有观察到显著差异。结论：在延长时间窗的急性缺血性脑卒中患者中，HUK加rT-PA的联合治疗可以安全地改善他们的功能结果。
期刊介绍：
The Neurologist publishes articles on topics of current interest to physicians treating patients with neurological diseases. The core of the journal is review articles focusing on clinically relevant issues. The journal also publishes case reports or case series which review the literature and put observations in perspective, as well as letters to the editor. Special features include the popular "10 Most Commonly Asked Questions" and the "Patient and Family Fact Sheet," a handy tear-out page that can be copied to hand out to patients and their caregivers.
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