Gelmers H J, Hennerici M
Department of Clinical Neurology, Twenteborg Ziekenhuis, Almelo, The Netherlands.
Stroke. 1990 Dec;21(12 Suppl):IV81-4.
In a review of pooled data from five double-blind, placebo-controlled studies of nimodipine in acute ischemic stroke, we compared the effect of 120 mg nimodipine given orally with that of placebo. In the five studies, 871 patients were followed, and 781 adhered to entry and inclusion criteria. End points were mortality and outcome at the end of the treatment period (21 or 28 days). Outcome was assessed with Mathew's scale and the physician's clinical judgement. The treatment and control groups were well matched with respect to demographic data, risk factors, and baseline Mathew scores. In the treatment group, 34 patients (7.9%) died during the treatment period, whereas 54 (12.3%) in the control group died, corresponding with a mortality reduction of 36%. Significantly less neurologic impairment at the end of the treatment period was documented under nimodipine treatment, and this impairment improved more in patients with moderate-to-severe stroke (baseline Mathew score less than 66) if administration of nimodipine occurred within 12 hours after stroke onset or if the patient was more than 65 years old. The overall incidence of adverse reactions was relatively modest, and these were of minor severity; only a few appeared to have more than a remote relation to the study medication.
在一项对尼莫地平治疗急性缺血性卒中的五项双盲、安慰剂对照研究的汇总数据回顾中，我们比较了口服120毫克尼莫地平与安慰剂的效果。在这五项研究中，对871名患者进行了随访，其中781名符合入选和纳入标准。终点指标为治疗期结束时（21天或28天）的死亡率和预后情况。预后采用马修量表和医生的临床判断进行评估。治疗组和对照组在人口统计学数据、危险因素和基线马修评分方面匹配良好。治疗组中有34名患者（7.9%）在治疗期间死亡，而对照组中有54名患者（12.3%）死亡，死亡率降低了36%。尼莫地平治疗组在治疗期结束时记录到的神经功能损害明显较少，对于中度至重度卒中（基线马修评分低于66分）患者，如果在卒中发作后12小时内给予尼莫地平治疗，或者患者年龄超过65岁，神经功能损害改善更为明显。不良反应的总体发生率相对较低，且严重程度较轻；只有少数不良反应似乎与研究药物有较密切的关系。
