Klinik für Neurologie, Universitätsklinik, Goethe-Universität, Frankfurt, Deutschland.
Cerebrovasc Dis. 2012;33(4):316-21. doi: 10.1159/000335816. Epub 2012 Feb 15.
Systemic thrombolysis for acute stroke was approved by German authorities in 2002. While recombinant tissue plasminogen activator (rtPA) use first remained low, systemic thrombolysis is nowadays an established part of common stroke care. The purpose of this study was to determine changes in systemic thrombolysis rates within an observation period of 7 years following the approval of rtPA therapy in Germany in a large state-wide stroke data set.
We analyzed a prospective hospital-based stroke registry covering the entire federal state of Hesse, Germany. All hospitals providing stroke care in Hesse (neurology hospitals and hospitals for internal medicine) are obligated to register all inpatients. All cases admitted between 2003 and 2009 with a final diagnosis of ischemic stroke (ICD-10: I63) were selected. We analyzed the relationship between thrombolysis rates, onset-to-admission time (hospital arrival ≤3 and >3 h after symptom onset), patient age (quartiles and dichotomized in ≤80 and >80 years) and disability at admission (assessed by the Rankin Scale). A one-way ANOVA with Bonferroni correction for multiple comparisons was performed to test for significant changes during the observation period.
88,340 patients with ischemic stroke were identified. Thrombolysis rates increased continuously from 2.5% in 2003 to 8.4% in 2009. In patients admitted within 3 h after symptom onset, the thrombolysis rate was 2.5-fold higher in 2009 (25.4%) as compared to 2003 (10.5%). The mean age (±SD) of thrombolyzed patients increased from 68.7 (±11.5) years in 2003 to 70.7 (±13.4) years in 2009 (p for trend = 0.014), but remained stable in the entire cohort. 20.1% of all systemic thrombolytic treatments were performed in patients >80 years old. Disability at admission decreased more pronouncedly in rtPA-treated patients (Rankin Scale score 0-2: 15.2% in 2003 and 24.5% in 2009; p for trend <0.001) as compared to the entire cohort (34.5% in 2003 and 41.5% in 2009; p for trend <0.001).
Thrombolytic therapy is increasingly used in acute stroke, particularly in patients admitted within the 3-hour time window. Higher treatment rates are at least partially explained by spreading rtPA application, including older and less severely affected patients. Approximately one fifth of all rtPA treatments were given to the very old (>80 years), which is outside the age limit for rtPA approval. In the light of upcoming demographic changes, the proportion of very aged stroke patients will increase substantially, further tightening the current discussion of an upper age limit for thrombolytic therapy.
2002 年德国批准了全身性溶栓治疗急性中风。虽然重组组织纤溶酶原激活剂（rtPA）的使用最初较低，但目前全身性溶栓治疗已成为常见的中风治疗的一部分。本研究的目的是在德国批准 rtPA 治疗后 7 年的观察期内，在一个大型全州性中风数据集内确定全身性溶栓治疗率的变化。
我们分析了一个覆盖德国黑森州全州的前瞻性医院为基础的中风登记处。黑森州提供中风护理的所有医院（神经病学医院和内科医院）都有义务登记所有住院病人。选择 2003 年至 2009 年间最终诊断为缺血性中风（ICD-10：I63）的所有病例。我们分析了溶栓治疗率与发病至入院时间（入院≤3 小时和>3 小时）、患者年龄（四分位数和≤80 岁和>80 岁）和入院时残疾（用 Rankin 量表评估）之间的关系。采用单向方差分析（Bonferroni 多重比较检验）来检验观察期内的显著变化。
共确定了 88340 例缺血性中风患者。溶栓治疗率从 2003 年的 2.5%连续增加到 2009 年的 8.4%。在症状发作后 3 小时内入院的患者中，2009 年的溶栓率（25.4%）是 2003 年（10.5%）的 2.5 倍。溶栓患者的平均年龄（±标准差）从 2003 年的 68.7（±11.5）岁增加到 2009 年的 70.7（±13.4）岁（趋势 p 值=0.014），但在整个队列中保持稳定。20.1%的全身性溶栓治疗是在>80 岁的患者中进行的。rtPA 治疗的患者入院时残疾程度下降更为明显（Rankin 量表评分 0-2：2003 年为 15.2%，2009 年为 24.5%；趋势 p 值<0.001），而整个队列为（2003 年为 34.5%，2009 年为 41.5%；趋势 p 值<0.001）。
溶栓治疗在急性中风中越来越多地使用，特别是在 3 小时时间窗内入院的患者。更高的治疗率至少部分解释为 rtPA 应用的扩展，包括较年长和病情较轻的患者。大约五分之一的 rtPA 治疗是给非常高龄（>80 岁）的患者，这超出了 rtPA 批准的年龄限制。鉴于即将到来的人口结构变化，非常高龄的中风患者比例将大幅增加，进一步加剧了目前对溶栓治疗上限年龄的讨论。
