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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Repeated-measures analysis of the National Institute of Neurological Disorders and Stroke rt-PA stroke trial.
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Repeated-measures analysis of the National Institute of Neurological Disorders and Stroke rt-PA stroke trial.

机译:美国国家神经疾病研究所和卒中rt-PA卒中试验的重复测量分析。

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Previous analyses, including the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stoke Trial, have assessed the clinical treatment efficacy only at single study point, but did not assess efficacy using outcomes collected at multiple time points and incorporate within-patient correlation. The data from the NINDS rt-PA Stroke Trial was analyzed with repeated-measures analysis with generalized estimating equations (GEE) approach using dichotomized outcomes (modified Rankin Scale [mRS], National Institutes of Health Stroke Scale [NIHSS], Barthel Index [BI], and Glasgow Outcome Scale [GOS]). The results were compared with data from previous analyses. All of the outcome variables at different time points were significantly correlated. rt-PA was superior to placebo overall and at specific time points individually. The overall odds of having minimal or no disability (mRS score 0 or 1) for patients treated with rt-PA was higher than those treated with placebo (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.5-3.0). The ORs were 2.3 (95% CI, 1.5-3.4) times higher at 3 months, 1.9 (95% CI, 1.3-2.8) times higher at 6 months, and 2.0 (95% CI, 1.3-2.9) times higher at 12 months. A similar treatment effect also was observed with the NIHSS, BI, and GOS. Compared with previous analyses, an augmented treatment effect with larger ORs and smaller P values were observed. Repeated-measures analysis provides an alternative method for assessing treatment effect, as demonstrated in the analysis of data from the NINDS rt-PA Stroke Trial. This method could be used in future stroke trials in which outcomes of interest are collected at multiple time points.
机译:先前的分析,包括美国国家神经疾病和中风研究所(NINDS)rt-PA斯托克试验,仅在单个研究点评估了临床治疗效果,但没有使用在多个时间点收集的结局并纳入患者内部评估疗效相关性。 NINDS rt-PA卒中试验的数据采用二分法结果(广义兰克量表[mRS],美国国立卫生研究院卒中量表[NIHSS],巴特尔指数[BI]),采用广义估计方程(GEE)的重复测量分析进行了分析。 ]和格拉斯哥成果量表[GOS])。将结果与先前分析的数据进行比较。在不同时间点的所有结果变量均显着相关。总体而言,在特定时间点,rt-PA优于安慰剂。接受rt-PA治疗的患者有最小残疾或无残疾(mRS评分为0或1)的总几率高于接受安慰剂的患者(几率[OR]为2.1; 95%置信区间[CI]为1.5-3.0) )。 3个月时OR升高2.3(95%CI,1.5-3.4)倍,6个月升高1.9(95%CI,1.3-2.8)倍,12个月时升高2.0(95%CI,1.3-2.9)倍几个月。 NIHSS,BI和GOS也观察到类似的治疗效果。与以前的分析相比,观察到较大的OR和较小的P值可增强治疗效果。重复测量分析提供了一种评估治疗效果的替代方法,如NINDS rt-PA中风试验数据的分析所示。该方法可用于将来的卒中试验中,在该试验中多个时间点收集感兴趣的结果。

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