静脉注射尿激酶与最佳药物治疗对急性轻度中风患者功能结局的影响（TRUST）：一项随机对照试验
Effect of intravenous urokinase vs best medicine treatment on functional outcome for patients with acute minor stroke (TRUST): a randomized controlled trial.
作者信息
Tao Yongli, Gao Yuan, Zhao Lu, Xu Yafang, Jiang Chenyang, Liu Kai, Fang Hui, Pei Lulu, Wang Xin, Zhang Rui, Wu Jun, Yang Jing, Han Xinsheng, Guo Hongling, Xue Baoguo, Li Jinlou, Liu Yuqian, Gu Hongqiu, Du Kejin, Cheng Xin, Dong Qiang, Wang Duolao, Buonanno Ferdinando S, Ning MingMing, Xu Yuming, Song Bo
机构信息
Department of Neurology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
NHC Key Laboratory of Prevention and Treatment of Cerebrovascular Disease, Zhengzhou, China.
出版信息
BMC Med. 2025 Jan 6;23(1):6. doi: 10.1186/s12916-024-03820-2.
BACKGROUND
The benefits of intravenous thrombolysis in patients with acute minor stroke remain controversial. For the aim of providing a better therapeutic strategy, high-quality trials are required to validate the efficacy of thrombolytic medicine other than intravenous recombinant tissue plasminogen and tenecteplase. In the trial, we evaluate the efficacy and safety of urokinase (UK) in acute minor stroke.
METHODS
This multicenter, open-label, blinded-endpoint, randomized controlled clinical trial enrolled patients with minor stroke within 6 h of symptom onset, with a NIHSS score ≤ 5. The trial was conducted at 25 hospitals in China between October 2020 and February 2023. Eligible patients were randomized to the UK group (1,000,000 U) or the best medicine treatment group. The responsible investigator recommended and implemented the best medicine treatment based on guidelines. The primary endpoint was an excellent functional outcome, defined as a modified Rankin scale (mRS) score of 0-1 at 90 days. The primary safety outcome was symptomatic intracranial hemorrhage (sICH) within 36 h.
RESULTS
A total of 999 patients were enrolled in the trial, the median age was 64 years, 371 (36.9%) were women; the median (IQR) NIHSS score was 3 (2-4). At 90 days, the primary endpoint was observed in 427 patients (84.9%) in the UK group and 425 patients (85.7%) in the control group (adjusted risk ratio [RR] 1.00, 95% CI 0.96-1.05, p = 0.87). A total of 3 patients in the UK-treated (0.6%) group experienced sICH compared to 1 patient (0.2%) in the control group (RR 1.83, 95% CI 0.16-20.27, p = 0.62).
CONCLUSIONS
For patients with acute minor stroke treated within 6 h of symptom onset, UK intravenous thrombolysis treatment was not found to be beneficial in terms of excellent functional outcome at 90 days, whereas it was safe.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04420351.
背景
急性轻度卒中患者静脉溶栓的益处仍存在争议。为了提供更好的治疗策略，需要高质量的试验来验证除静脉注射重组组织型纤溶酶原和替奈普酶之外的溶栓药物的疗效。在本试验中，我们评估了尿激酶（UK）治疗急性轻度卒中的疗效和安全性。
方法
这项多中心、开放标签、终点设盲、随机对照临床试验纳入了症状发作6小时内、美国国立卫生研究院卒中量表（NIHSS）评分≤5分的轻度卒中患者。该试验于2020年10月至2023年2月在中国的25家医院进行。符合条件的患者被随机分为尿激酶组（100万单位）或最佳药物治疗组。责任研究者根据指南推荐并实施最佳药物治疗。主要终点是良好的功能结局，定义为90天时改良Rankin量表（mRS）评分为0 - 1分。主要安全结局是36小时内出现症状性颅内出血（sICH）。
结果
共有999例患者纳入试验，中位年龄为64岁，371例（36.9%）为女性；中位（四分位间距）NIHSS评分为3分（2 - 4分）。90天时，尿激酶组427例患者（84.9%）达到主要终点，对照组425例患者（85.7%）达到主要终点（调整风险比[RR]为1.00，95%置信区间为0.96 - 1.05，p = 0.87）。尿激酶治疗组有3例患者（0.6%）发生症状性颅内出血，而对照组有1例患者（0.2%）发生症状性颅内出血（RR为1.83，95%置信区间为0.16 - 20.27，p = 0.62）。
结论
对于症状发作6小时内接受治疗的急性轻度卒中患者，90天时尿激酶静脉溶栓治疗在良好功能结局方面未显示出益处，但该治疗是安全的。
试验注册
ClinicalTrials.gov标识符：NCT04420351。
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