Acute Stroke Unit, University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary, Glasgow, UK.
Stroke. 2010 Nov;41(11):2612-7. doi: 10.1161/STROKEAHA.110.589317. Epub 2010 Oct 14.
Baseline stroke severity predicts outcomes among thrombolysed patients. The baseline National Institutes of Health Stroke Scale (NIHSS) thresholds are sometimes used to select patients for thrombolysis, clinical trial enrollment, or both. Using data lodged with Virtual International Stroke Trials Archive, we compared adjusted outcomes between thrombolysed and nonthrombolysed patients enrolled in neuroprotection trials (1998-2007) to assess the influence of various levels of baseline NIHSS. Method-We assessed the association of treatment with outcome, measured across the modified Rankin scale score distribution, in patients categorized by baseline NIHSS in increments of 4. We used an age and baseline NIHSS adjusted Cochran-Mantel-Haenszel test followed by proportional odds logistic regression analysis. We report the Cochran-Mantel-Haenszel P values and estimated odds ratios (OR) for improved modified Rankin scale score distribution with treatment for patients within each baseline NIHSS category.
Data were available for 5817 patients (1585 thrombolysed and 4232 nonthrombolysed). Baseline severity was greater among thrombolysed than nonthrombolysed (median baseline NIHSS, 14 vs 13; P < 0.05). An association of treatment with outcome was seen independently and was of similar magnitude within each of the baseline NIHSS categories 5 to 8 (P=0.04; OR, 1.25; 95% confidence interval [CI], 1.0-1.6; N = 278/934 thrombolysed/nonthrombolysed), 9 to 12 (P = 0.01; OR, 1.3; 95% CI, 1.1-1.6; N = 404/942), 13 to 16 (P < 0.05; OR, 1.6; 95% CI, 1.3-2.1; N = 342/814), 17 to 20 (P < 0.05; OR, 1.7; 95% CI, 1.3-2.1; N = 311/736), and 21 to 24 (P < 0.05; OR, 1.6; 95% CI, 1.1-2.1; N = 178/466). No association was observed within baseline NIHSS categories 1 to 4 (P = 0.8; OR, 1.1; 95% CI, 0.3-4.4; N = 8/161) or ≥ 25 (P = 0.08; OR, 1.1; 95% CI, 0.7-1.9; N = 64/179).
In this nonrandomized comparison, outcomes after thrombolysis were significantly better than in untreated comparators across baseline NIHSS 5 to 24. The significant association was lost only at extremes of baseline NIHSS when sample sizes were small and confidence limits were wide.
基线卒中严重程度可预测溶栓患者的结局。美国国立卫生研究院卒中量表（NIHSS）的基线阈值有时用于选择溶栓患者、临床试验入组或两者兼而有之。利用虚拟国际卒中试验档案的数据，我们比较了神经保护试验（1998-2007 年）中溶栓和未溶栓患者的调整后结局，以评估不同基线 NIHSS 水平的影响。方法-我们评估了按基线 NIHSS 每增加 4 分进行分类的患者中，治疗与结局的关系，通过改良 Rankin 量表评分分布进行衡量。我们使用年龄和基线 NIHSS 调整的 Cochrane-Mantel-Haenszel 检验，然后进行比例优势逻辑回归分析。我们报告 Cochran-Mantel-Haenszel P 值和估计的优势比（OR），用于评估每个基线 NIHSS 类别内接受治疗的患者改良 Rankin 量表评分分布的改善。
共纳入 5817 例患者（1585 例溶栓和 4232 例未溶栓）。溶栓组基线严重程度高于未溶栓组（中位数基线 NIHSS，14 分比 13 分；P<0.05）。治疗与结局之间存在独立关联，并且在基线 NIHSS 5-8 分（P=0.04；OR，1.25；95%置信区间[CI]，1.0-1.6；N=278/934 溶栓/未溶栓）、9-12 分（P=0.01；OR，1.3；95%CI，1.1-1.6；N=404/942）、13-16 分（P<0.05；OR，1.6；95%CI，1.3-2.1；N=342/814）、17-20 分（P<0.05；OR，1.7；95%CI，1.3-2.1；N=311/736）和 21-24 分（P<0.05；OR，1.6；95%CI，1.1-2.1；N=178/466）这些基线 NIHSS 类别中观察到治疗与结局之间存在显著关联。在基线 NIHSS 类别 1-4 分（P=0.8；OR，1.1；95%CI，0.3-4.4；N=8/161）或≥25 分（P=0.08；OR，1.1；95%CI，0.7-1.9；N=64/179）时未观察到关联。
在这项非随机比较中，溶栓后结局明显优于未经治疗的对照组，基线 NIHSS 为 5-24 分。仅在基线 NIHSS 的极端情况下，样本量较小且置信区间较宽时，才失去了显著关联。
