Deguchi Ichiro, Tanahashi Norio, Takao Masaki
Department of Neurology, Saitama Medical University International Medical Center, Saitama, Japan.
Department of Neurology, Saitama Medical University International Medical Center, Saitama, Japan.
J Stroke Cerebrovasc Dis. 2018 Apr;27(4):1033-1040. doi: 10.1016/j.jstrokecerebrovasdis.2017.11.009. Epub 2017 Dec 6.
An intravenous recombinant tissue plasminogen activator (rt-PA, alteplase .6 mg/kg) for acute cerebral infarction within 3 hours of onset was approved in Japan in 2005. The treatment window was subsequently extended to within 4.5 hours of onset. However, few Japanese studies have compared the efficacy and safety of rt-PA therapy between patients treated within 3 hours and patients treated within 3-4.5 hours.
This study included 323 patients who received rt-PA for acute cerebral infarction within 3 hours or 3-4.5 hours between April 2007 and March 2017. Patients' characteristics, outcomes (modified Rankin Scale [mRS] score at 3 months), and symptomatic intracranial hemorrhage (sICH) were retrospectively investigated.
Of the 323 patients, 219 were treated within 3 hours and 104 were treated at 3-4.5 hours. Among patients receiving rt-PA alone, 154 were treated within 3 hours (3-hour group), and 69 were treated at 3-4.5 hours (3-4.5-hour group). There was no difference in the sICH rate (3.9% versus 4.3%, respectively; P = 1.00) or mRS score of 0-1 (38.3% versus 40.6%, respectively; P = .76) between these groups. In patients receiving additional neuroendovascular therapy, 65 were in the 3-hour group and 35 were in the 3-4.5-hour group. There was no significant difference in the sICH rate (1.5% versus 0%, respectively; P = 1.00) or mRS score of 0-1 (30.8% versus 31.4%, respectively; P = 1.00) between these groups.
Low-dose rt-PA treatment from either 3 or 3-4.5 hours after acute cerebral infarction has the same efficacy and safety.
2005年，静脉注射重组组织型纤溶酶原激活剂（rt-PA，阿替普酶，剂量为0.6mg/kg）用于急性脑梗死发病3小时内的治疗在日本获得批准。随后治疗时间窗延长至发病4.5小时内。然而，很少有日本研究比较在3小时内接受治疗的患者与在3 - 4.5小时内接受治疗的患者接受rt-PA治疗的疗效和安全性。
本研究纳入了2007年4月至2017年3月期间在3小时内或3 - 4.5小时内接受rt-PA治疗急性脑梗死的323例患者。对患者的特征、结局（3个月时的改良Rankin量表[mRS]评分）和症状性颅内出血（sICH）进行回顾性调查。
在323例患者中，219例在3小时内接受治疗，104例在3 - 4.5小时内接受治疗。在仅接受rt-PA治疗的患者中，154例在3小时内接受治疗（3小时组），69例在3 - 4.5小时内接受治疗（3 - 4.5小时组）。这些组之间的sICH发生率（分别为3.9%和4.3%；P = 1.00）或mRS评分为0 - 1的比例（分别为38.3%和40.6%；P = 0.76）没有差异。在接受额外神经血管内治疗的患者中，3小时组有65例，3 - 4.5小时组有35例。这些组之间的sICH发生率（分别为1.5%和0%；P = 1.00）或mRS评分为0 - 1的比例（分别为30.8%和31.4%；P = 1.00）没有显著差异。
急性脑梗死发病3小时或3 - 4.5小时后进行低剂量rt-PA治疗具有相同的疗效和安全性。
