Department of Neurology, University of Pennsylvania, Philadelphia, PA 19104, USA.
Stroke. 2013 Jul;44(7):2025-7. doi: 10.1161/STROKEAHA.113.000870. Epub 2013 May 9.
Two randomized trials suggested that transcranial laser therapy (TLT) may benefit patients with acute ischemic stroke, although efficacy has not been confirmed. Supportive proof of concept could be demonstrated if TLT reduces the volume of cortical infarction.
The NeuroThera Efficacy and Safety Trial-2 (NEST-2) was a randomized trial of TLT versus sham in patients with acute ischemic stroke treated within 24 hours of onset. Infarct volumes were measured quantitatively and semiquantitatively on all protocol-required computed tomography (or MRI, if clinically indicated) scans performed on day 5 (±2). Two approaches assessed treatment effects on cortex: (1) indirectly, by analyzing total infarct volume among patients with clinical presentations suggesting cortical involvement; and (2) directly, by assessing the cortical Alberta Stroke Program Early CT Score (cASPECTS) components (M1-M6, anterior, posterior) on a 0- to 8-point modified scale.
A total of 640 subjects had scans (576 computed tomography, 64 MRI) on day 5. The reliability of ASPECTS (intraclass correlation coefficient=0.85) and cASPECTS (intraclass correlation coefficient=0.82) was excellent, and total ASPECTS was correlated with total infarct volume (r=0.71). In the overall study population, there was no impact of TLT on total infarct volume (P=0.30), total ASPECTS (P=0.85), or cASPECTS (P=0.89). Similarly, no effect was seen in any of the following prespecified subgroups selected to indicate cortical involvement: baseline National Institutes of Health Stroke Scale score >10, Oxfordshire Total Anterior Circulation Syndrome, subjects with aphasia or extinction at baseline, or subjects with radiographic involvement of cortex.
TLT was not associated with a reduction in overall or cortical infarct volume as measured on computed tomography in the subacute phase.
两项随机试验表明，经颅激光治疗（TLT）可能有益于急性缺血性脑卒中患者，尽管其疗效尚未得到证实。如果 TLT 可减少皮质梗死体积，则可以提供支持性概念验证。
NeuroThera 疗效和安全性试验-2（NEST-2）是一项 TLT 与假对照治疗急性缺血性脑卒中患者的随机试验，这些患者在发病后 24 小时内接受治疗。在第 5 天（±2 天）进行的所有协议要求的计算机断层扫描（或临床需要时的磁共振成像）扫描上定量和半定量测量梗死体积。采用两种方法评估治疗对皮质的影响：（1）通过分析临床表现提示皮质受累的患者中总梗死体积间接评估；（2）通过评估 0-8 分改良量表上的皮质 Alberta 卒中计划早期 CT 评分（cASPECTS）成分（M1-M6、前、后）直接评估。
共有 640 名患者在第 5 天进行了扫描（576 次 CT，64 次 MRI）。ASPECTS（组内相关系数=0.85）和 cASPECTS（组内相关系数=0.82）的可靠性极好，总 ASPECTS 与总梗死体积呈正相关（r=0.71）。在总体研究人群中，TLT 对总梗死体积（P=0.30）、总 ASPECTS（P=0.85）或 cASPECTS（P=0.89）均无影响。同样，在选择表明皮质受累的以下预定亚组中也未观察到效果：基线国立卫生研究院卒中量表评分>10，牛津郡全前循环综合征，基线时存在失语症或失认症，或影像学显示皮质受累的患者。
在亚急性期的 CT 上，TLT 与总梗死体积或皮质梗死体积的减少无关。
