Acute Stroke Unit, University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary & Faculty of Medicine, Glasgow, UK.
Stroke. 2010 Dec;41(12):2840-8. doi: 10.1161/STROKEAHA.110.586206. Epub 2010 Oct 28.
Thrombolysis for acute ischemic stroke in patients aged > 80 years is not approved in some countries due to limited trial data in the very elderly. We compared outcomes between thrombolysed and nonthrombolysed (control) patients from neuroprotection trials to assess any influence of age on response. Method-Among patients with ischemic stroke of known age, pretreatment severity (baseline National Institutes of Health Scale Score), and 90-day outcome (modified Rankin Scale score; National Institutes of Health Scale score), we compared the distribution of modified Rankin score in thrombolysed patients with control subjects by Cochran-Mantel-Haenszel test and then logistic regression after adjustment for age and baseline National Institutes of Health Scale score. We examined patients ≤ 80 and ≥ 81 years separately and then each age decile.
Rankin data were available for 5817 patients, 1585 thrombolysed and 4232 control subjects; 20.5% were aged > 80 years (mean ± SD, 85.1 ± 3.4 years). Baseline severity was higher among thrombolysed than control subjects (median National Institutes of Health Scale score 14 versus 13, P < 0.05). The distribution of modified Rankin Scale scores was better among thrombolysed patients (P < 0.0001; OR, 1.39; 95% CI, 1.26 to 1.54). The association occurred independently with similar magnitude among young (P < 0.0001; OR, 1.42; 95% CI, 1.26 to 1.59) and elderly (P = 0.002; OR, 1.34; 95% CI, 1.05 to 1.70) patients. ORs were consistent across all age deciles > 30 years; outcomes assessed by National Institutes of Health Scale score gave supporting significant findings, and dichotomized modified Rankin Scale score outcomes were also consistent.
Outcome after thrombolysis for acute ischemic stroke was significantly better than in control subjects. Despite the expected poorer outcomes among elderly compared with young patients that is independent of any treatment effect, the association between thrombolysis treatment and improved outcome is maintained in the very elderly. Age alone should not be a barrier to treatment.
由于高龄患者的临床试验数据有限,一些国家不批准对 80 岁以上的急性缺血性脑卒中患者进行溶栓治疗。我们比较了神经保护试验中溶栓治疗和未溶栓(对照组)患者的结局,以评估年龄对反应的影响。方法:在已知年龄的缺血性脑卒中患者中,我们比较了溶栓患者和对照组患者的治疗前严重程度(基线国立卫生研究院量表评分)和 90 天结局(改良 Rankin 量表评分;国立卫生研究院量表评分),通过 Cochran-Mantel-Haenszel 检验比较溶栓患者和对照组患者改良 Rankin 量表评分的分布,然后根据年龄和基线国立卫生研究院量表评分进行逻辑回归分析。我们分别检查了≤80 岁和≥81 岁的患者,然后检查了每个年龄组。
5817 例患者的 Rankin 数据可用,其中 1585 例接受溶栓治疗,4232 例为对照组;20.5%的患者年龄>80 岁(平均±标准差,85.1±3.4 岁)。与对照组相比,溶栓组患者基线严重程度更高(中位数国立卫生研究院量表评分 14 分比 13 分,P<0.05)。溶栓患者的改良 Rankin 量表评分分布更好(P<0.0001;比值比,1.39;95%置信区间,1.26 至 1.54)。这种关联在年轻患者(P<0.0001;比值比,1.42;95%置信区间,1.26 至 1.59)和老年患者(P=0.002;比值比,1.34;95%置信区间,1.05 至 1.70)中独立存在,且具有相似的幅度。在所有>30 岁的年龄组中,比值比均一致;用国立卫生研究院量表评分评估的结局也得出了支持的显著发现,二分法改良 Rankin 量表评分结局也一致。
急性缺血性脑卒中溶栓治疗后的结局明显优于对照组。尽管与年轻患者相比,老年患者的预期结局较差,且与任何治疗效果无关,但溶栓治疗与改善结局之间的关联在非常高龄患者中仍然存在。年龄本身不应成为治疗的障碍。