Department of Neurology, Chongqing General Hospital, Chongqing, China.
Department of Neurology, Southwest Jiaotong University Affiliated Hospital, Chengdu Third People's Hospital, Chengdu, China.
CNS Neurosci Ther. 2024 Aug;30(8):e14877. doi: 10.1111/cns.14877.
The objective of this study was to evaluate the effectiveness of batroxobin in improving functional outcomes and reducing stroke recurrence among patients with acute ischemic stroke beyond the therapeutic time window for thrombolytic therapy.
This multicenter, retrospective study enrolled 492 patients with acute moderate-to-severe ischemic stroke within 24 h. 238 patients were given standard (basic) therapy. On the basis of standard treatment, 254 patients received an initial intravenous infusion of batroxobin 10 U on day 1, followed by subsequent infusions of batroxobin 5 U on the 3rd and 5th days, respectively.
In the batroxobin group, 8.3% of patients experienced recurrence stroke, compared to 17.2% in the control group (HR, 0.433; 95% CI, 0.248 to 0.757; p = 0.003). Furthermore, intravenous batroxobin significantly improved the distribution of 90-120 day disability. Moderate-to-severe bleeding events were reported in three patients (1.2%) in the batroxobin group and one patient (0.4%) in the control group (p = 0.369).
Among patients with acute moderate-to-severe ischemic stroke beyond the time window for thrombolytic therapy, treatment with intravenous batroxobin had a lower risk of stroke recurrence and a better recovery of function outcome without increasing bleeding events. Prospective studies are needed to further confirm.
本研究旨在评估巴曲酶在溶栓治疗时间窗之外改善急性缺血性脑卒中患者功能结局和降低卒中复发的效果。
这是一项多中心、回顾性研究，共纳入 492 例发病 24 小时内的急性中重度缺血性脑卒中患者。238 例患者接受标准（基础）治疗。在标准治疗基础上，254 例患者于第 1 天给予 10 U 初始静脉滴注巴曲酶，第 3、5 天分别给予后续 5 U 静脉滴注。
巴曲酶组有 8.3%的患者复发卒中，而对照组为 17.2%（HR：0.433，95%CI：0.2480.757，p=0.003）。此外，静脉巴曲酶明显改善了 90120 天残疾分布。巴曲酶组有 3 例（1.2%）患者发生中重度出血事件，对照组有 1 例（0.4%）（p=0.369）。
在溶栓治疗时间窗之外的急性中重度缺血性脑卒中患者中，静脉应用巴曲酶治疗卒中复发风险较低，功能结局恢复较好，且不增加出血事件。需要进一步开展前瞻性研究加以证实。
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