不同剂量重组组织型纤溶酶原激活剂治疗中国急性脑卒中患者的疗效。
Different doses of recombinant tissue-type plasminogen activator for acute stroke in Chinese patients.
机构信息
From the Graduate Institute of Clinical Medicine and Department of Neurology, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan (A.-C.C., C.-K.L.); Department of Neurology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan (A.-C.C., C.-K.L.); Department of Neurology, College of Medicine, National Cheng Kung University, Tainan, Taiwan (C.-H.C.); Department of Neurology, Chi-Mei Medical Center, Tainan, Taiwan (H.-J.L.); Department of Neurology, China Medical University Hospital, Taichung, Taiwan (C.-H.L.); Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan (J.-S.J.); Graduate Institute of Clinical Medicine and Department of Neurology, College of Medicine, Taipei Medical University, Taipei, Taiwan (C.-J.H., H.-H.H.); Department of Neurology, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan (C.-P.C., W.-Y.S.); and Department of Neurology, Tungs' Taichung Metro Harbor Hospital and Department of Neurology, School of Medicine, Chung Shan Medical University, Taichung, Taiwan (H.-Y.H.).
出版信息
Stroke. 2014 Aug;45(8):2359-65. doi: 10.1161/STROKEAHA.114.005245. Epub 2014 Jul 3.
BACKGROUND AND PURPOSE
The relationship between the dose of recombinant tissue-type plasminogen activator (r-tPA) and its safety/efficacy for ischemic stroke has not been well evaluated in the East Asian population. We assessed the safety/efficacy of different doses of r-tPA for acute ischemic stroke in Chinese patients.
METHODS
A total of 1004 eligible patients were classified according to the dose of r-tPA received for managing acute ischemic stroke: 0.9 mg/kg (n=422), 0.8 mg/kg (n=202), 0.7 mg/kg (n=199), and 0.6 mg/kg (n=181). The safety outcome was symptomatic intracerebral hemorrhage and death within 3 months. The efficacy outcome was good functional outcome (modified Rankin Scale ≤1) at 3 months.
RESULTS
There was a significant trend for symptomatic intracerebral hemorrhage with age (P=0.002). With multivariate logistic regression analysis, a dose of 0.9 mg/kg was a predictor of symptomatic intracerebral hemorrhage (P=0.0109), and a dose ≤0.65 mg/kg was a predictor of good functional outcome (P=0.0369). In patients aged 71 to 80 years, there was a significant trend of increasing symptomatic intracerebral hemorrhage (P=0.0130) and less good functional outcome (P=0.0179) with increasing doses of r-tPA. There was also a trend of increasing mortality (P=0.0971) at 3 months in these patients.
CONCLUSIONS
These results did not support the dose of 0.9 mg/kg of r-tPA being optimal for all patients in the East Asian population. In elderly patients (71-80 years), a lower dose of 0.6 mg/kg is associated with a better outcome. Confirmation of the results through randomized trial is required.
背景与目的
重组组织型纤溶酶原激活剂（r-tPA）剂量与其在东亚人群中治疗缺血性脑卒中的安全性/疗效之间的关系尚未得到很好的评估。我们评估了不同剂量 r-tPA 治疗中国患者急性缺血性脑卒中的安全性/疗效。
方法
根据 r-tPA 治疗急性缺血性脑卒中的剂量，将 1004 例符合条件的患者分为四组：0.9 mg/kg（n=422）、0.8 mg/kg（n=202）、0.7 mg/kg（n=199）和 0.6 mg/kg（n=181）。安全性结局为 3 个月内症状性颅内出血和死亡。疗效结局为 3 个月时改良 Rankin 量表评分≤1 的良好功能结局。
结果
症状性颅内出血与年龄呈显著趋势（P=0.002）。多变量逻辑回归分析显示，0.9 mg/kg 剂量是症状性颅内出血的预测因素（P=0.0109），剂量≤0.65 mg/kg 是良好功能结局的预测因素（P=0.0369）。在 71-80 岁的患者中，r-tPA 剂量增加与症状性颅内出血增加（P=0.0130）和良好功能结局减少（P=0.0179）呈显著趋势。这些患者的 3 个月死亡率也呈上升趋势（P=0.0971）。
结论
这些结果不支持东亚人群中所有患者使用 0.9 mg/kg r-tPA 剂量为最佳剂量。在老年患者（71-80 岁）中，使用较低的 0.6 mg/kg 剂量与更好的结局相关。需要通过随机试验来证实这些结果。
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