Lancet. 1990 Nov 17;336(8725):1205-9.
The value of oral nimodipine 120 mg per day for acute stroke was assessed in a randomised, double-blind, placebo-controlled multicentre study of 1215 patients. The primary end-point was independence after 6 months, defined as a score of 60 or more on an activities of daily living (ADL) scale, the Barthel index. Patients were entered into the trial if they were aged over 40, became hemiparetic in the previous 48 h, were conscious, were able to swallow, and had been living independently before the stroke. At 6 months, 55% of the nimodipine group and 58% of the placebo group were independent, the odds ratio for independence on nimodipine being 0.88 (95% confidence limits 0.70-1.10). For mortality the odds ratio with nimodipine was 1.22 (95% confidence limits 0.95-1.57). ADL and neurological scores also suggested delayed recovery in the nimodipine group at 3 weeks. The results do not support the case for oral nimodipine therapy 120 mg per day starting within 48 h of the stroke, for patients with acute stroke.
在一项针对1215例患者的随机、双盲、安慰剂对照多中心研究中，评估了每天口服120毫克尼莫地平对急性中风的疗效。主要终点是6个月后的独立状态，定义为日常生活活动（ADL）量表（巴氏指数）得分60分或以上。如果患者年龄超过40岁，在过去48小时内出现偏瘫，意识清醒，能够吞咽，且中风前独立生活，则纳入试验。6个月时，尼莫地平组55%的患者和安慰剂组58%的患者达到独立状态，尼莫地平组独立的优势比为0.88（95%置信区间0.70 - 1.10）。关于死亡率，尼莫地平组的优势比为1.22（95%置信区间0.95 - 1.57）。ADL和神经学评分也表明尼莫地平组在3周时恢复延迟。对于急性中风患者，研究结果不支持在中风后48小时内开始每天口服120毫克尼莫地平治疗。
