Kent David M, Hinchey Judith, Price Lori Lyn, Levine Steven R, Selker Harry P
Institute for Clinical Research and Health Policy Studies, Department of Medicine, Tufts-New England Medical Center, 750 Washington St, Box 63, Boston, Mass 02111, USA.
Stroke. 2004 May;35(5):1141-6. doi: 10.1161/01.STR.0000125712.02090.6e. Epub 2004 Apr 15.
In patients with acute ischemic stroke, intracranial hemorrhages are categorized as symptomatic or asymptomatic based on the presence or absence of a clinically detectable neurological deterioration. Asymptomatic intracranial hemorrhages are believed by many to be clinically innocuous. We examined whether the occurrence of an asymptomatic intracranial hemorrhage affects functional outcome in patients with acute ischemic stroke (AIS) treated or not treated with recombinant tissue plasminogen activator (rt-PA).
We combined data from the NINDS rt-PA Stroke Trial and the ATLANTIS Trials, excluding patients with symptomatic intracranial hemorrhage (n=1193). We used generalized estimating equations to test whether asymptomatic intracranial hemorrhage altered the likelihood of a normal or near-normal outcome at 90 days, as measured across 4 commonly used functional outcome scales, controlling for other variables that affect outcome. To look at additional outcomes, including the likelihood of disability and death, we used logistic regression equations. Additionally, we systematically reviewed previous studies that assessed the effect of intracranial hemorrhage in AIS.
In the combined database, the rate of asymptomatic intracranial hemorrhage was higher in rt-PA treated than in nontreated patients (9.9% versus 4.2%, P<0.0001). Controlling for other prognostic factors, the odds of a normal or near-normal outcome was lower when a patient had an asymptomatic intracranial hemorrhage, but this effect did not reach statistical significance (OR=0.69, 95% CI: 0.43 to 1.12, P=0.13). Similarly, the odds of not being moderately to severely disabled (modified Rankin Score < or =2) was also lower for patients with asymptomatic intracranial hemorrhage (OR=0.60, 95% CI: 0.33 to 1.08, P=0.09). Despite using a larger sample than any previously published study, the power in our study to detect a 30% decrease in the odds of a good outcome was inadequate ( approximately 32%).
We could not confirm or exclude a clinically significant effect for asymptomatic intracranial hemorrhages based either on our analysis or on any previously published trial. Analysis of substantially larger databases are needed to assess the import of this common clinical event.
在急性缺血性卒中患者中，颅内出血根据是否存在临床上可检测到的神经功能恶化分为有症状或无症状。许多人认为无症状颅内出血在临床上无害。我们研究了无症状颅内出血的发生是否会影响接受或未接受重组组织型纤溶酶原激活剂（rt-PA）治疗的急性缺血性卒中（AIS）患者的功能结局。
我们合并了美国国立神经疾病与卒中研究所（NINDS）rt-PA卒中试验和ATLANTIS试验的数据，排除了有症状颅内出血的患者（n = 1193）。我们使用广义估计方程来测试无症状颅内出血是否改变了90天时正常或接近正常结局的可能性，这是通过4种常用的功能结局量表进行衡量的，同时控制其他影响结局的变量。为了观察其他结局，包括残疾和死亡的可能性，我们使用了逻辑回归方程。此外，我们系统回顾了先前评估颅内出血对AIS影响的研究。
在合并数据库中，接受rt-PA治疗的患者无症状颅内出血的发生率高于未治疗患者（9.9%对4.2%，P<0.0001）。在控制其他预后因素后，患者发生无症状颅内出血时正常或接近正常结局的几率较低，但这种影响未达到统计学意义（OR = 0.69，95%CI：0.43至1.12，P = 0.13）。同样，无症状颅内出血患者无中度至重度残疾（改良Rankin评分≤2）的几率也较低（OR = 0.60，95%CI：0.33至1.08，P = 0.09）。尽管我们使用的样本量比以往任何已发表的研究都大，但我们的研究检测良好结局几率降低30%的效能不足（约32%）。
基于我们的分析或任何先前发表的试验，我们无法证实或排除无症状颅内出血具有临床显著影响。需要分析规模大得多的数据库来评估这一常见临床事件的重要性。
