Stroke Unit, Department of Neurology, IRYCIS, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Eur J Neurol. 2012 Mar;19(3):390-4. doi: 10.1111/j.1468-1331.2011.03517.x. Epub 2011 Sep 6.
Therapy for stroke with intravenous tissue plasminogen activator (IV-tPA) is hampered by tight licensing restrictions; some of them have been discussed in recent literature. We assessed the safety and effectiveness of off-label IV-tPA in the clinical settings.
Retrospective analysis of all the patients treated with IV-tPA at our Stroke Unit. Patients were divided into two groups by licence criteria [on-label group (OnLG), off-label group (OffLG)]. Primary outcome measures were symptomatic intracranial haemorrhages (sICH), major systemic haemorrhages, modified Rankin scale (mRS) and mortality rate at 3months.
Five hundred and five patients were registered, 269 (53.2%) were assigned to OnLG and 236 (46.9%) to OffLG. Inclusion criteria for the OffLG were aged >80 years (129 patients), time from onset of symptoms to treatment over 3h (111), prior oral anticoagulant treatment with International Normalised Ratio≤1.7 (41), combination of previous stroke and diabetes mellitus (14), surgery or severe trauma within 3months of stroke (13), National Institutes of Health Stroke Scale score over 25 (11), intracranial tumours (5), systemic diseases with risk of bleeding (7) and seizure at the onset of stroke (2). No significant differences were identified between both groups regarding the proportion of sICH (OnLG 2.2% vs. OffLG 1.6%, P=0.78) or the 3-month mortality rate (11.1% vs. 19%: odds ratio (OR), 1.49; 95% CI, 0.86-2.55; P=0.14). Multivariate analysis showed no significant differences in functional independence at 3months between both groups (mRS <3 64.3% vs. 50.4%: OR mRS >2 1.7; 95% CI, 0.96-2.5; P=0.07).
Intravenous thrombolysis may be safe and efficacious beyond its current label restrictions.
静脉注射组织型纤溶酶原激活剂（IV-tPA）治疗中风受到严格的许可限制；最近的文献中已经讨论了其中的一些限制。我们评估了临床环境中使用超说明书 IV-tPA 的安全性和有效性。
对我院卒中单元接受 IV-tPA 治疗的所有患者进行回顾性分析。根据许可标准将患者分为两组[标签内组（OnLG）和标签外组（OffLG）]。主要结局测量指标为症状性颅内出血（sICH）、主要全身性出血、改良 Rankin 量表（mRS）和 3 个月时的死亡率。
共登记了 505 名患者，269 名（53.2%）被分配到 OnLG，236 名（46.9%）被分配到 OffLG。OffLG 的纳入标准为年龄>80 岁（129 例）、症状发作至治疗时间超过 3 小时（111 例）、国际标准化比值≤1.7 的先前口服抗凝治疗（41 例）、先前中风和糖尿病合并症（14 例）、卒中后 3 个月内手术或严重创伤（13 例）、国立卫生研究院卒中量表评分>25 分（11 例）、颅内肿瘤（5 例）、有出血风险的系统性疾病（7 例）和卒中发作时的癫痫（2 例）。两组间 sICH 比例（OnLG 2.2% vs. OffLG 1.6%，P=0.78）或 3 个月死亡率（11.1% vs. 19%：优势比（OR）1.49；95%可信区间，0.86-2.55；P=0.14）均无显著差异。多变量分析显示，两组 3 个月时的功能独立性无显著差异（mRS<3 64.3% vs. 50.4%：OR mRS>2 1.7；95%可信区间，0.96-2.5；P=0.07）。
静脉溶栓治疗可能在超出其目前标签限制的情况下是安全有效的。
