Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland.
Stroke. 2010 Jul;41(7):1450-8. doi: 10.1161/STROKEAHA.109.576140. Epub 2010 Jun 10.
Numerous contraindications included in the license of alteplase, most of which are not based on scientific evidence, restrict the portion of patients with acute ischemic stroke eligible for treatment with alteplase. We studied whether off-label thrombolysis was associated with poorer outcome or increased rates of symptomatic intracerebral hemorrhage compared with on-label use.
All consecutive patients with stroke treated with intravenous thrombolysis from 1995 to 2008 at the Helsinki University Central Hospital were registered (n=1104). After excluding basilar artery occlusions (n=119), the study population included 985 patients. Clinical outcome (modified Rankin Scale 0 to 2 versus 3 to 6) and symptomatic intracerebral hemorrhage according to 3 earlier published criteria were analyzed with a logistic regression model adjusting for 21 baseline variables.
One or more license contraindications to thrombolysis was present in 51% of our patients (n=499). The most common of these were age >80 years (n=159), mild stroke National Institutes of Health Stroke Scale score <5 (n=129), use of intravenous antihypertensives prior to treatment (n=112), symptom-to-needle time >3 hours (n=95), blood pressure >185/110 mm Hg (n=47), and oral anticoagulation (n=39). Age >80 years was the only contraindication independently associated with poor outcome (OR, 2.18; 95% CI, 1.27 to 3.73) in the multivariate model. None of the contraindications were associated with an increased risk of symptomatic intracerebral hemorrhage.
Off-license thrombolysis was not associated with poorer clinical outcome, except for age >80 years, nor with increased rates of symptomatic intracerebral hemorrhage. The current extensive list of contraindications should be re-evaluated when data from ongoing randomized trials and observational studies become available.
阿替普酶的许可中包含许多禁忌症，其中大多数禁忌症都没有科学依据，限制了符合阿替普酶溶栓治疗条件的急性缺血性脑卒中患者的比例。我们研究了与适应证内溶栓相比，适应证外溶栓是否与较差的结局或更高的症状性颅内出血发生率相关。
1995 年至 2008 年在赫尔辛基大学中心医院接受静脉溶栓治疗的所有连续卒中患者均进行了登记（n=1104）。排除基底动脉闭塞（n=119）后，研究人群包括 985 例患者。使用逻辑回归模型，根据 3 项早期发表的标准，对临床结局（改良 Rankin 量表 0-2 分与 3-6 分）和症状性颅内出血进行分析，并对 21 项基线变量进行调整。
我们的患者中有 51%（n=499）存在 1 项或多项溶栓禁忌证。其中最常见的是年龄＞80 岁（n=159）、轻度卒中国立卫生研究院卒中量表评分＜5（n=129）、治疗前使用静脉降压药（n=112）、症状出现至溶栓时间＞3 小时（n=95）、血压＞185/110mmHg（n=47）和口服抗凝剂（n=39）。在多变量模型中，年龄＞80 岁是唯一与不良结局独立相关的禁忌症（OR，2.18；95%CI，1.27 至 3.73）。没有禁忌症与症状性颅内出血风险增加相关。
除年龄＞80 岁外，适应证外溶栓与较差的临床结局或更高的症状性颅内出血发生率无关。当前，应在现有随机试验和观察性研究的数据可用时，重新评估广泛的禁忌症列表。
