Intracerebral hemorrhage after intravenous t-PA therapy for ischemic stroke
Intracerebral hemorrhage after intravenous t-PA therapy for ischemic stroke
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DOI：
10.1161/01.str.28.11.2109
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发表时间：
1997-11-01
期刊：
影响因子：
8.3
通讯作者：
Fong, WC
中科院分区：
文献类型：
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作者：
Brott, T;Broderick, J;Fong, WC
背景和目的：我们试图确定与接受组织纤溶酶原激活剂（t-PA）治疗的急性缺血性卒中患者脑出血相关的变量，我们对一项随机、双盲、安慰剂对照试验的数据进行了亚组分析，该试验对卒中患者在发病3小时内静脉注射t-PA。使用多变量回归建模程序，我们评估了基线和治疗后变量与症状性和无症状性脑出血的关系，在第一个36小时后treatment.Results，总的来说，t-PA治疗的患者有症状性脑出血的绝对风险增加6%，3个月死亡率的绝对风险降低4%，与安慰剂治疗的患者相比。在312例t-PA治疗患者的最终多变量logistic回归模型中，与症状性脑出血风险增加独立相关的唯一变量是神经功能缺损的严重程度（通过美国国立卫生研究院卒中量表评分测量）（5个类别;比值比[OR]，1.8; 95%置信区间[CI]，1.2 ~ 2.9）和脑水肿（定义为急性低密度）或治疗前CT的占位效应（OR，7.8; 95% CI，2.2 ~ 27.1）。最终模型正确预测了t-PA治疗的患者是否会出现症状性出血，有效率仅为57%。在重度神经功能缺损患者亚组中，t-PA治疗患者比安慰剂治疗患者更有可能获得有利的3个月结局（基于多个结局调整的OR，4.3; 95% CI，1.6 - 11.9）。CT显示水肿或肿块效应的亚组的这些结果相似（校正OR，3.4; 95% CI，0.6 - 20.7）。对于具有这两种基线特征的t-PA治疗患者和安慰剂治疗患者，严重残疾或死亡的可能性相似。结论尽管脑内出血的发生率较高，但基线CT显示严重中风或水肿或占位效应的患者是合理的候选人如果在发病后3小时内给予t-PA。
Background and Purpose We sought to identify variables associated with intracerebral hemorrhage in patients with acute ischemic stroke who receive tissue plasminogen activator (t-PA).Methods We performed subgroup analyses of data from a randomized, double-blind, placebo-controlled trial of intravenous t-PA administered to stroke patients within 3 hours of onset. Using multivariable regression modeling procedures, we assessed the relationship of baseline and after-treatment variables with symptomatic and asymptomatic intracerebral hemorrhage during the first 36 hours after treatment.Results Overall, t-PA-treated patients had an increase in the absolute risk of symptomatic intracerebral hemorrhage of 6% and a decrease in the absolute risk of 3-month mortality of 4% compared with placebo-treated patients. The only variables independently associated with an increased risk of symptomatic intracerebral hemorrhage in the final multivariable logistic regression model for the 312 t-PA-treated patients were the severity of neurological deficit as measured by the National Institutes of Health Stroke Scale score (five categories; odds ratio [OR], 1.8; 95% confidence interval [CI], 1.2 to 2.9) and brain edema (defined as acute hypodensity) or mass effect by CT before treatment (OR, 7.8; 95% CI,2.2 to 27.1). This final model correctly predicted those t-PA-treated patients who would or would not have a symptomatic hemorrhage with only 57% efficiency. In the subgroup of patients with a severe neurological deficit, t-PA-treated patients were more likely than placebo-treated patients to have a favorable 3-month outcome (adjusted OR based on multiple outcomes, 4.3; 95% CI, 1.6 to 11.9). These results were similar for the subgroup with edema or mass effect by CT (adjusted OR, 3.4; 95% CI, 0.6 to 20.7). The likelihood of severe disability or death was similar for t-PA- and placebo-treated patients with these two baseline characteristics.Conclusions Despite a higher rate of intracerebral hemorrhage, patients with severe strokes or edema or mass effect on the baseline CT are reasonable candidates for t-PA, if it is administered within 3 hours of onset.