Acute Stroke Unit, University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary & Faculty of Medicine, University of Glasgow, Glasgow, UK.
Neurology. 2011 Nov 22;77(21):1866-72. doi: 10.1212/WNL.0b013e318238ee42. Epub 2011 Nov 16.
Patients with concomitant diabetes mellitus (DM) and prior stroke (PS) were excluded from European approval of alteplase in stroke. We examined the influence of DM and PS on the outcomes of patients who received thrombolytic therapy (T; data from Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register) compared to nonthrombolyzed controls (C; data from Virtual International Stroke Trials Archive).
We selected ischemic stroke patients on whom we held data on age, baseline NIH Stroke Scale score (NIHSS), and 90-day modified Rankin Scale score (mRS). We compared the distribution of mRS between T and C by Cochran-Mantel-Haenszel (CMH) test and proportional odds logistic regression, after adjustment for age and baseline NIHSS, in patients with and without DM, PS, or the combination. We report odds ratios (OR) for improved distribution of mRS with 95% confidence interval (CI) and CMH p value.
Data were available for 29,500 patients: 5,411 (18.5%) had DM, 5,019 had PS (17.1%), and 1,141 (5.5%) had both. Adjusted mRS outcomes were better for T vs C among patients with DM (OR 1.45 [1.30-1.62], n = 5,354), PS (OR 1.55 [1.40-1.72], n = 4,986), or concomitant DM and PS (OR 1.23 [0.996-1.52], p = 0.05, n = 1,136), all CMH p < 0.0001. These are comparable to outcomes between T and C among patients with neither DM nor PS: OR = 1.53 (1.42-1.63), p < 0.0001, n = 19,339. There was no interaction on outcome between DM and PS with alteplase treatment (tissue plasminogen activator × DM × PS, p = 0.5). Age ≤80 years or >80 years did not influence our findings.
Outcomes from thrombolysis are better than the controls among patients with DM, PS, or both. We find no statistical justification for the exclusion of these patients from receiving thrombolytic therapy.
在欧洲批准阿替普酶用于治疗脑卒中时，同时患有糖尿病（DM）和既往脑卒中（PS）的患者被排除在外。我们通过比较接受溶栓治疗（T；来自 Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register 的数据）的患者和未溶栓的对照组（C；来自 Virtual International Stroke Trials Archive 的数据），研究了 DM 和 PS 对患者结局的影响。
我们选择了年龄、基线 NIH 卒中量表评分（NIHSS）和 90 天改良 Rankin 量表评分（mRS）方面有数据的缺血性脑卒中患者。我们使用 Cochran-Mantel-Haenszel（CMH）检验和比例优势逻辑回归比较了 T 组和 C 组的 mRS 分布，对年龄和基线 NIHSS 进行了调整，分别在 DM、PS 或两者同时存在的患者中进行了比较。我们报告了 mRS 分布改善的比值比（OR）及其 95%置信区间（CI）和 CMH p 值。
共有 29500 名患者的数据可用：5411 名（18.5%）患有 DM，5019 名（17.1%）患有 PS，1141 名（5.5%）同时患有 DM 和 PS。在患有 DM（OR 1.45 [1.30-1.62]，n = 5354）、PS（OR 1.55 [1.40-1.72]，n = 4986）或同时患有 DM 和 PS（OR 1.23 [0.996-1.52]，p = 0.05，n = 1136）的患者中，T 治疗与 C 相比，调整后的 mRS 结局更好，所有 CMH p < 0.0001。这些结果与既无 DM 也无 PS 的患者中 T 与 C 之间的结果相似：OR = 1.53（1.42-1.63），p < 0.0001，n = 19339。阿替普酶治疗与 DM 和 PS 之间的交互作用对结局没有影响（组织型纤溶酶原激活物×DM×PS，p = 0.5）。年龄≤80 岁或>80 岁并不影响我们的发现。
在患有 DM、PS 或两者同时存在的患者中，溶栓治疗的结局优于对照组。我们没有发现统计学上的理由将这些患者排除在溶栓治疗之外。
