Kent David M, Price Lori Lyn, Ringleb Peter, Hill Michael D, Selker Harry P
Institute for Clinical Research and Health Policy Studies, Tufts-New England Medical Center, 750 Washington Street, #63, Boston, MA, 02111, USA.
Stroke. 2005 Jan;36(1):62-5. doi: 10.1161/01.STR.0000150515.15576.29. Epub 2004 Nov 29.
Women experience worse outcomes after stroke compared with men. Prior work has suggested sex-based differences in coagulation and fibrinolysis markers in subjects with acute stroke. We explored whether sex might modify the effect of recombinant tissue plasminogen activator (rtPA) on outcomes in patients with acute ischemic stroke.
Using a combined database including subjects from the National Institute of Neurological Disorders and Stroke (NINDS), Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke (ATLANTIS) A and B, and the Second European Cooperative Acute Stroke Study (ECASS II) trials, we examined 90-day outcomes in patients randomized to rtPA versus placebo by sex. We used logistic regression to control for potential confounders.
Among 988 women treated between 0 and 6 hours from symptom onset, patients receiving rtPA were significantly more likely than those receiving placebo to have a modified Rankin Score < or =1 (40.5% versus 30.3%, P<0.0008). Among 1190 men, the trend toward benefit in the overall group did not reach statistical significance (38.5% versus 36.7%, P=0.52). An unadjusted analysis showed that women were significantly more likely to benefit from rtPA compared with men (P=0.04). Controlling for age, baseline National Institutes of Health Stroke Scale, diabetes, symptom onset to treatment time, prior stroke, systolic blood pressure, extent of hypoattenuation on baseline computed tomography scan and several significant interaction terms (including onset to treatment time-by-treatment and systolic blood pressure-by treatment) did not substantially change the strength of the interaction between gender and rtPA treatment (P=0.04).
In this pooled analysis of rtPA in acute ischemic stroke, women benefited more than men, and the usual gender difference in outcome favoring men was not observed in the thrombolytic therapy group. For patients presenting at later time intervals, when the risks and benefits of rtPA are more finely balanced, sex may be an important variable to consider for patient selection.
与男性相比，女性中风后的预后更差。先前的研究表明，急性中风患者的凝血和纤维蛋白溶解标志物存在基于性别的差异。我们探讨了性别是否可能改变重组组织型纤溶酶原激活剂（rtPA）对急性缺血性中风患者预后的影响。
使用一个综合数据库，其中包括来自美国国立神经疾病与中风研究所（NINDS）、急性缺血性中风非介入性溶栓治疗阿替普酶（ATLANTIS）A和B试验以及第二次欧洲急性中风协作研究（ECASS II）试验的受试者，我们按性别检查了随机接受rtPA与安慰剂治疗的患者的90天预后。我们使用逻辑回归来控制潜在的混杂因素。
在症状发作后0至6小时接受治疗的988名女性中，接受rtPA治疗的患者改良Rankin评分≤1的可能性显著高于接受安慰剂治疗的患者（40.5%对30.3%，P<0.0008）。在1190名男性中，总体组的获益趋势未达到统计学意义（38.5%对36.7%，P=0.52）。未经调整的分析显示，与男性相比，女性从rtPA治疗中获益的可能性显著更高（P=0.04）。控制年龄、基线美国国立卫生研究院卒中量表评分、糖尿病、症状发作至治疗时间、既往中风史、收缩压、基线计算机断层扫描上的低密度程度以及几个显著的交互项（包括症状发作至治疗时间×治疗和收缩压×治疗）后，性别与rtPA治疗之间的交互强度没有实质性变化（P=0.04）。
在这项对急性缺血性中风中rtPA的汇总分析中，女性比男性获益更多，并且在溶栓治疗组中未观察到通常在预后方面有利于男性的性别差异。对于就诊时间较晚的患者，当rtPA的风险和获益更为平衡时，性别可能是患者选择时需要考虑的一个重要变量。
