Sobesky Jan, Frackowiak Monika, Zaro Weber Olivier, Hahn Moritz, Möller-Hartmann Walter, Rudolf Jobst, Neveling Michael, Grond Martin, Schmulling Susanne, Jacobs Andreas, Heiss Wolf-Dieter
Max Planck Institute for Neurological Research, University of Cologne, Cologne, Germany.
Cerebrovasc Dis. 2007;24(1):56-65. doi: 10.1159/000103117. Epub 2007 May 22.
Predictors of outcome and safety in intravenous thrombolysis within 3 h in clinical routine is a matter of ongoing debate. Available reports contain small patient numbers or summarize heterogeneous multicenter data.
Four hundred and fifty patients received intravenous thrombolysis within 3 h after stroke. Pretreatment NIHSS score and detailed medical history were analyzed. Noncontrast CT was performed before thrombolysis, 24-36 h later and in case of clinical deterioration. Symptomatic intracranial hemorrhage (SICH; any bleeding with an NIHSS increase of > or =4 points) and clinical outcome (modified Rankin Scale, mRS) after 3 months were recorded. Logistic regression identified parameters predictive of independence (mRS 0-2) and SICH.
Median onset to admission, door to needle and onset to treatment time was 75, 50 and 135 min, respectively. Direct presentation by emergency service (64%) was the fastest way of referral. Median pretreatment NIHSS was 11 points. Independence (mRS 0-2) was reached by 53%. Mortality was 11% (7% intracerebral, 4% extracerebral complications). Logistic regression identified low NIHSS, low age and absent diabetes as predictors of independence. Overall hemorrhagic complications and SICH were found in 18 and 4% of the patients, respectively. Extracerebral bleeding complications and allergic reactions were found in 3 and 1%, respectively.
This largest single center report presents a sample in the range of the 3 h rt-PA cohort of all randomized controlled trials. Outcome was comparable to randomized studies with a higher rate of independence and a lower rate of mortality and SICH.
临床常规中3小时内静脉溶栓治疗的预后及安全性预测因素一直存在争议。现有报告纳入的患者数量较少，或汇总了异质性多中心数据。
450例患者在卒中后3小时内接受了静脉溶栓治疗。分析了治疗前的美国国立卫生研究院卒中量表（NIHSS）评分及详细病史。溶栓前、溶栓后24 - 36小时以及临床病情恶化时均进行了非增强CT检查。记录了有症状性颅内出血（SICH；任何导致NIHSS评分增加≥4分的出血）及3个月后的临床结局（改良Rankin量表，mRS）。逻辑回归分析确定了预测独立（mRS 0 - 2）及SICH的参数。
从发病到入院、从进院到穿刺及从发病到治疗的中位时间分别为75分钟、50分钟和135分钟。急诊直接送达（64%）是最快的转诊方式。治疗前NIHSS评分中位数为11分。53%的患者达到了独立（mRS 0 - 2）。死亡率为11%（7%为颅内病变，4%为脑外并发症）。逻辑回归分析确定低NIHSS评分、低年龄及无糖尿病是独立的预测因素。分别有18%和4%的患者出现了总体出血并发症及SICH。脑外出血并发症及过敏反应的发生率分别为3%和1%。
这份最大的单中心报告提供了一个样本，其范围与所有随机对照试验的3小时重组组织型纤溶酶原激活剂（rt - PA）队列研究相当。预后与随机研究相当，独立率更高，死亡率及SICH发生率更低。
