Kaste M, Fogelholm R, Erilä T, Palomäki H, Murros K, Rissanen A, Sarna S
Department of Neurology, University of Helsinki, Finland.
Stroke. 1994 Jul;25(7):1348-53. doi: 10.1161/01.str.25.7.1348.
A randomized, double-blind, placebo-controlled multicenter trial was conducted to test the hypothesis that nimodipine would improve the functional outcome in acute ischemic hemispheric stroke.
A total of 350 patients were randomized to nimodipine 120 mg/d PO or matching placebo for 21 days. Randomization was stratified by onset of therapy, age, and stroke severity. Treatment was begun within 48 hours of onset. The patients had neurological evaluation on admission, on days 1, 7, and 21, and at 3 and 12 months. The primary end points were Rankin grade, neurological score, and mobility at 12 months.
We did not find any differences in the functional outcome between the treatment groups or between the stratified subgroups. We were also unable in post hoc analyses to find any groups of patients who benefited from nimodipine. During the first month and at 3 months the case-fatality rate was higher in the nimodipine-treated patients than in those on placebo (P = .004 and P = .030, respectively), but at the 1-year follow-up this difference had lost statistical significance. During the first week nimodipine had a statistically significant lowering effect on both systolic (P = .005) and diastolic (P = .013) blood pressure.
Nimodipine did not improve the functional outcome of acute ischemic hemispheric stroke. The early case-fatality rate was higher in the nimodipine group, possibly due to the blood pressure-lowering effect of nimodipine.
开展了一项随机、双盲、安慰剂对照的多中心试验，以检验尼莫地平可改善急性缺血性半球卒中功能结局的假设。
总共350例患者被随机分为口服尼莫地平120mg/d组或匹配的安慰剂组，治疗21天。随机分组按治疗开始时间、年龄和卒中严重程度进行分层。在发病48小时内开始治疗。患者在入院时、第1天、第7天和第21天以及3个月和12个月时进行神经学评估。主要终点为12个月时的Rankin分级、神经学评分和活动能力。
我们未发现治疗组之间或分层亚组之间在功能结局上存在任何差异。我们在事后分析中也未能发现任何从尼莫地平治疗中获益的患者亚组。在第一个月和3个月时，尼莫地平治疗患者的病死率高于安慰剂治疗患者（分别为P = 0.004和P = 0.030），但在1年随访时，这种差异已无统计学意义。在第一周，尼莫地平对收缩压（P = 0.005）和舒张压（P = 0.013）均有统计学显著的降低作用。
尼莫地平未能改善急性缺血性半球卒中的功能结局。尼莫地平组早期病死率较高，可能是由于尼莫地平的降压作用所致。
