Strokes with minor symptoms: an exploratory analysis of the National Institute of Neurological Disorders and Stroke recombinant tissue plasminogen activator trials.
Strokes with minor symptoms: an exploratory analysis of the National Institute of Neurological Disorders and Stroke recombinant tissue plasminogen activator trials.
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DOI：
10.1161/strokeaha.110.593632
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发表时间：
2010-11
期刊：
影响因子：
8.3
通讯作者：
Broderick JP
中科院分区：
文献类型：
--
作者：
Khatri P;Kleindorfer DO;Yeatts SD;Saver JL;Levine SR;Lyden PD;Moomaw CJ;Palesch YY;Jauch EC;Broderick JP
关键的NINDS rt-PA试验排除了有特殊轻微症状或症状迅速改善的缺血性中风患者。Rt-PA产品标签指出，它在治疗轻微神经缺陷或迅速改善中风症状方面的用途尚未得到评估。因此，NIHSS评分低的患者在临床实践中并不常见。我们试图进一步确定纳入NINDS试验的轻度中风患者的特征。在这项回顾分析中，轻微中风在基线时被定义为NIHSS≤5，因为在临床实践和试验中，这一亚组最常被排除在治疗之外。根据预先指定的NIHSS条目得分集群来定义临床中风综合征。对临床结果进行总体回顾，并在这些亚组中进行。在NINDS试验中，只有58例患者的NIHSS评分为≤0-5(42例rt-PA和16例安慰剂)，2,971例患者因主要原因为“迅速改善”或“轻微症状”而被排除在试验之外。没有患者有孤立的运动症状、孤立的面部下垂、孤立的共济失调、构音障碍、孤立的感觉症状，或仅有症状/体征未被NIHSS评分(即NIHSS=0)。试验中有三名或更少的患者，其中每一名患者都有其他孤立的缺陷。NINDS试验排除了大量有轻微症状的中风，纳入的中风数量很少，无法根据特定症状得出关于结果的结论。需要对这一亚组进行进一步的前瞻性、系统性研究。
The pivotal NINDS rt-PA trials excluded ischemic stroke patients with specific minor presentations or rapidly improving symptoms. The rt-PA product label notes that its use for minor neurological deficit or rapidly improving stroke symptoms has not been evaluated. As a result, patients with low NIHSS scores are not commonly treated in clinical practice. We sought to further characterize the minor stroke patients that were included in the NINDS trials. Minor strokes were defined as NIHSS ≤ 5 at baseline for this retrospective analysis, as this subgroup is most commonly excluded from treatment in clinical practice and trials. Clinical stroke syndromes were defined based on prespecified NIHSS item score clusters. Clinical outcomes were reviewed generally and within these cluster subgroups. Only 58 cases had NIHSS scores of ≤0–5 in the NINDS trials (42 rt-PA and 16 placebo), and 2971 patients were excluded from the trials due to “rapidly improving” or “minor symptoms” as the primary reason. No patients were enrolled with isolated motor symptoms, isolated facial droop, isolated ataxia, dysarthria, isolated sensory symptoms, or with only symptoms/signs not captured by the NIHSS score (i.e., NIHSS=0). There were three or fewer patients with each of the other isolated deficits enrolled in the trial. The NINDS trials excluded a substantial number of strokes with minor presentations, those that were included were small in number, and conclusions about outcomes based on specific syndromes cannot be drawn. Further prospective, systematic study of this subgroup is needed.